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  • For the Record - November 7 - REMINDER: Time to Zipline!

    Nov 15, 2016 at 10:22am

    It's Time for Everyone to Zipline!

    All IRB applications for new studies must now be submitted through Zipline and must use the new IRB Protocol application form. This means:

    1. No more initial applications will be accepted on paper.
    2. All initial paper application forms have been removed from the HSD website as of November 1.
    3. For questions, send an email to hsdinfo@uw.edu, or contact the Team Operations Lead for your department.
    Team Contact
    IRB Team A Laurie Berger, lberger@uw.edu, 206.543.3033
    IRB Team B Galen Basse, gkbasse@uw.edu, 206.685.1211
    IRB Team D Leah Miller, lemiller@uw.edu, 206.543.2977
    IRB Team J Amanda Guyton, aguyton7@uw.edu, 206.616.5576

    If you don't know who your department contact is, use this PDF form to find them.


    Anniversary Dates of IRB Approval

    Zipline does not allow the beginning of your next IRB approval to be the same date as the beginning of your previous IRB approval period. In other words, studies will not be able to retain an "anniversary date" from year to year. The only exception is when the IRB's approval is literally granted on your anniversary date.

    For readers who know some of the arcane details of the human subjects regulations, the retention of the anniversary date is based on the "30-day rule". When the IRB reviews and approves the Status Report (Continuing Review application) for a study within 30 days of the expiration of the current approval period, the anniversary date may be retained for the next approval period. However, Zipline does not support the 30-day rule. Instead, Zipline requires the start date of the new approval period to be the same as the date of IRB approval.

    Example: Your new study received IRB approval on October 12, 2016. The approval expires on October 11, 2017.

    • In the past, we would have been able to start your next approval period on October 12, 2017, as long as the IRB granted your new approval anytime during the 30 days prior to October 12, 2017.
    • Now, the start of your next approval period will be the date on which your IRB approval was granted. If the IRB approves the research on October 1, 2017 for one year, the new approval period would start on October 1, 2017 and IRB approval would expire on September 30, 2018.

    We know that many researchers like the anniversary date approach, and we are sorry that we cannot continue it. We explored the possibility of customizing Zipline to allow it, but the cost was prohibitive.


    Welcome New HSD Staff

    HSD has successfully filled the positions advertised in early fall. Please welcome the new and newly-promoted staff to HSD:

    Person Position Team
    Paige Bacon-Abdelmeteleb IRB Administrator IRB Team A
    Liz Liss IRB Administrator IRB Team B
    Jennifer McBride IRB Administrator IRB Team B
    Rachel Thomas IRB Administrator IRB Team B
    Casey Evans Post Approval Monitor Regulatory Affairs
    Adrienne Meyer Assistant Director for Researcher Support Management
    Lisa Newmark Metrics and Reporting Specialist Operations

     


    Review Turn-around Times

    For studies reviewed by the UW IRB

    Does not apply to requests to use an external IRB

    HSD review turn-around times will be significantly longer than usual for Fall Quarter 2016. Please plan accordingly and allow extra time for the completion of the review process. The reasons include:

    • Training of new staff.
    • The large number of departments that began using Zipline on November 1.
    • The increasing number of "conversion applications" - i.e., paper-based applications for approved studies that must be converted to an electronic Zipline application.

    Quick Tips

    So this little thing called "Zipline" happened, and now we're in this new world of Roles and Permissions and Access Levels.

    Quick Tips would like to take you through a frequently encountered Zipline scenario, and then point you to some resources. Here we go!

    I'm a research coordinator, and I've entered all my study information into Zipline, and I've uploaded all my documents to the correct categories, and I've assigned the PI...

    And now I can't submit! What's going on?

    Only the PI, or the PI's Proxy can submit a study. This is because this action affirms that the PI is assuming responsibility for all aspects of the study. Think of it as an ink signature. We can't give that role to just anyone, right? Once a PI is named, Zipline will only recognize the PI as having the ability to submit. This is where assigning a PI Proxy comes into play.

    Check out our amazing instructions and education page, but specifically "Managing Access to the Zipline Application", and watch the video or read the instructions for assigning a PI Proxy. Have your PI give you the permission to submit that study via the PI Proxy role. You'll soon be role-ing along in Zipline again!

  • For the Record - October 17 - Time to Zipline!

    Oct 18, 2016 at 12:34pm

    It's Time for Everyone to Zipline!

    November 1

    Zipline will be open to all departments on all three campuses submitting a new IRB application on November 1. This means:

    1. No more initial applications will be accepted on paper.
    2. All initial paper application forms will be removed from the HSD website on November 1.
    3. For questions, send an email to hsdinfo@uw.edu, or contact the Team Operations Lead for your department.
    Team Contact
    IRB Team A Laurie Berger, lberger@uw.edu, 206.543.3033
    IRB Team B Galen Basse, gkbasse@uw.edu, 206.685.1211
    IRB Team D Leah Miller, lemiller@uw.edu, 206.543.2977
    IRB Team J Amanda Guyton, aguyton7@uw.edu, 206.616.5576

    If you don't know who your department contact is, use this PDF form to find them.


    WIRB's Initial Review Submission Form

    Important new question has been added

    Most UW industry-initiated clinical trials are reviewed by WIRB instead of the UW IRB. WIRB has added a new question to Page 1 of their WCG Initial Review Submission Form that asks the submitter to identify the submitting institution. This information will better ensure that WIRB links the UW to the submission when WIRB receives it.

    Here is what the question looks like on the form. For name, insert University of Washington. For WIRB institution number, insert 55014.

    WIRB Form

  • For the Record - October 3 - Turn-around Times

    Oct 3, 2016 at 2:33pm

    Review Turn-around Times

    HSD review turn-around times will be significantly longer than usual for Fall Quarter 2016. Please plan accordingly and allow extra time for the completion of the review process. The reasons include:

    • Four vacant IRB Administrator positions must be filled, and then the individuals must be trained.
    • The roll-out of the last half of the Zipline implementation schedule. Approximately 50% of academic units will begin using Zipline on November 1.
    • The increasing number of "conversion applications" - i.e., paper-based applications for approved studies that must be converted to an electronic Zipline application.

    Zipline Updates

    The need to decide which initial paper application to use is finally ending! On November 1, all academic units will begin using Zipline for new applications. The six types of initial paper applications will all be retired and removed from our website.

    Get Ready:

    1. All remaining academic units begin using Zipline on November 1. See the roll out and conversion schedule here.
    2. As of November 1, no paper applications for new studies will be accepted.
    3. The six paper initial applications will be removed from HSD's website.
      • PAPER APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee
      • PAPER APPLICATION: Specimen or Data Use, Non-Identifiable (and self-determination)
      • PAPER APPLICATION: Specimen or Data Use, Identifiable (PDF and Word) Use for Medical Records Review
      • PAPER APPLICATION: Determination, Exempt Status (PDF and Word)
      • PAPER APPLICATION: Center, Program, or Training Grant
      • PAPER APPLICATION: Repository
    4. Take advantage of all the learning materials on the Zipline Education webpages
    5. The Zipline Roadshows are being repeated in September and October

    Because so many departments will begin using Zipline on November 1, these in-person presentations are being repeated. They will include refreshed, up-to-date information based on the first three months of Zipline implementation.

    Topic Date Time Location
    Zipline: The software & process Thu, Oct 6 2:30 to 3:20pm Foege Auditorium*
    The new IRB application form Tue, Oct 4 9:30 to 10:30am Foege Auditorium*
    The new IRB application form Wed, Oct 5 9:00 to 10:00am Harborview R & T #109/113
    The new IRB application form Fri, Oct 14 9:00 to 10:00am Tower Auditorium*
    Conversion of existing IRB applications Thu, Oct 13 8:30 to 9:30am Foege Auditorium*
    Conversion of existing IRB applications Thu, Oct 13 2:00 to 3:00pm Tower Auditorium*
    Conversion of existing IRB applications Fri, Oct 14 2:30 to 3:30pm Harborview R & T #109/113
    Zipline: General overview Wed, Oct 5 11:30 to 1:00pm Bothell: Discovery Hall Rm 464
    Zipline: General overview Thu, Oct 20 12:30 to 1:30 pm Tacoma: Tioga Library Bldg. Atrium, 3rd Floor (307b)

    *Webinar


    Departmental Access to Studies in Zipline

    Departments can obtain access to the IRB applications submitted by their faculty, staff, and students. Please see the INSTRUCTIONS: Create Default Department Access and INSTRUCTIONS: Department Access to IRB Studies.

    Send an email to hsdinfo@uw.edu if you have any questions, or need assistance with this process.


    Want Help With Your Zipline "Conversion" Application?

    Effective Immediately

    The UW's Institute of Translational Health Sciences (ITHS) has a Research Coordination Center (RCC) that consists of a multidisciplinary team of research coordinators, regulatory specialists, research nurses, and study monitors who can support the design and conduct of clinical and translational research.

    The RCC is offering fee-based conversion assistance to investigators who need to convert their existing UW paper-based IRB applications to a Zipline application. The RCC and HSD have worked together to ensure that this service will efficiently meet the Zipline conversion requirements. The RCC will:

    • Work with your study team to identify the information needed to complete the conversion process
    • Complete the conversion application SmartForm and required supplements
    • Submit the completed conversion study documents to Zipline
    • Upload relevant study documents to the Zipline system
    • Be available for follow-up questions from HSD staff and IRB members

    HSD highly recommends this service, and is grateful to ITHS for its willingness to develop and provide this significant time-saving support to investigators. Contact ITHS through the Contact email form available on the ITHS Conversion webpage.


    GCP Training Required for NIH-Funded Clinical Trials

    Implementation: January 1, 2017

    Good Clinical Practice (GCP) training will soon be required for the PI and clinical trial staff of all NIH-funded clinical trials, including ongoing trials. GCP principles help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct and reporting.

    For new NIH grant awards, providing documentation of training completion will be part of the Just-in-Time process associated with NIH grant awards. It is not clear yet how NIH will implement this requirement for current awards. HSD and OSP are working together to clarify this issue for researchers.

    Specific details of this new requirement are listed here:

    QUESTION ANSWER
    When is the implementation date? January 1, 2017
    Which research is affected? All current and future NIH grants and contracts that fund clinical trials
    Who has to take the GCP training? The principal investigator (PI) and clinical trial staff
    Does this requirement replace the current NIH requirement for training on protections for human subjects? No. GCP training is required in addition to, and complements, the existing training requirement
    Who is responsible for retaining documentation of completed GCP training? The NIH policy states, "Recipients of GCP training are expected to retain documentation of their training."
    Is a refresher course required? Yes. GCP training must be refreshed at least every three years.
    Where/how can UW researchers obtain GCP training? Current options are listed here. HSD is investigating additions to these options.

    *Note: GCP Training is already required for PIs conducting FDA-regulated clinical trials with an investigational drug or device, and for many industry trials.


    Emergency Medicine Checklist and Application Supplement

    Available now

    A Checklist is now available for emergency medicine research that requires the special consent waiver called "exception for informed consent (EFIC)". The Checklist describes the regulatory and UW policy requirements for IRB approval of this type of research. Emergency medicine research can occur in any clinical department or setting, and it involves a subject population that is not capable of providing informed consent - for example, individuals with cardiac arrest. The research typically does not qualify for a standard waiver of consent because it involves more than minimal risk.

    An Exception from Informed Consent Supplement must accompany any new IRB application for this type of research.


    Registration of Clinical Trials at CT.gov

    Implementation: January 18, 2017

    The federal requirement to register clinical trials has been expanded to include additional trials, additional information elements, and new penalties for non-compliance. These expanded requirements are the joint result of a new NIH policy and an expanded regulation from the Food and Drug Administration and the Department of Health & Human Services. A summary table describes the changes. Three especially noteworthy changes are:

    • The NIH policy expands the registration requirement to all clinical trials funded in whole, or in part, by NIH, regardless of study phase or type of intervention.
    • A sentence about the trial registration must be inserted into the study consent form, using the words provided by the FDA and NIH.
    • Possible non-compliance penalties include:
      • Identifying the clinical trial record as non-compliant in ClinicalTrials.gov
      • Suspension or termination of grant or contract funding, if required registration and reporting cannot be verified
      • Consideration of the non-compliance in future funding decisions
      • Civil monetary penalties to the "responsible party" (PI) of up to $10,000/day

    HSD, the UW Office of Research, and the Office of Sponsored Programs are collaborating with others at the UW to explore ways to help support researchers in meeting these requirements.

    In the meantime, information on how to do the initial registration of a clinical trial is available on the HSD website.

  • Zipline Fall Roadshows

    Sep 19, 2016 at 10:38am
    Zipline Roadshow, Round 2

    The Roadshows at various campus locations are being repeated, with updated and refreshed information based on the past three and a half months of experience with Zipline. Some of the presentations will be broadcast as webinars and made available on the HSD website. See the links in the table for the Adobe Connect webinars. The presentations in Foege will also be webcast via Mediasite. The links for these will be published soon.

     
    Topic Date Time Location
    Zipline: The software & process Fri, Sept 30 10:30 to 11:30am Tower Auditorium*
    Zipline: The software & process Thu, Oct 6 2:30 to 3:20pm Foege Auditorium*
    The new IRB application form Tue, Oct 4 9:30 to 10:30am Foege Auditorium
    The new IRB application form Wed, Oct 5 9:00 to 10:00am Harborview R & T #109/113
    The new IRB application form Fri, Oct 14 9:00 to 10:00am Tower Auditorium*
    Conversion of existing IRB applications Thu, Oct 13 8:30 to 9:30am Foege Auditorium*
    Conversion of existing IRB applications Thu, Oct 13 2:00 to 3:00pm Tower Auditorium*
    Conversion of existing IRB applications Fri, Oct 14 2:30 to 3:30pm Harborview R & T #109/113
    Zipline: General overview Wed, Oct 5 11:30 to 1:00pm Bothell: Discovery Hall Rm 464
    Zipline: General overview Thu, Oct 20 12:30 to 1:30pm Tacoma: Tioga Library Bldg. Atrium, 3rd Floor (307b)

    *Webcast

  • zNews - HSD Zipline Rollout - Last Issue!

    Sep 15, 2016 at 9:23am
    Last Issue

    This is the last edition of HSD's zNews.

    This series of 16 issues was released every other week (sometimes weekly) to provide you with detailed information about our new eIRB system called Zipline and its implementation on campus. The key topics have now been covered, and last week we began expanding Zipline's implementation to many other departments and programs.

    Past issues will continue to be available on the HSD Announcements page, well after all departments have begun using Zipline.


    Zipline Roadshow, Round 2

    The Roadshows at various campus locations are being repeated, with updated and refreshed information based on the past three and a half months of experience with Zipline. Some of the presentations will be broadcast as webinars and made available on the HSD website. See the links in the table for the Adobe Connect webinars. The presentations in Foege will also be webcast via Mediasite. The links for these will be published on our announcements page soon.

     

    Topic Date Time Location
    Zipline: The software & process Thu, Sept 29 2:30 to 3:30pm Harborview R & T Auditorium
    Zipline: The software & process Fri, Sept 30 10:30 to 11:30am Tower Auditorium*
    Zipline: The software & process Thu, Oct 6 2:30 to 3:20pm Foege Auditorium*
    The new IRB application form Tue, Oct 4 9:30 to 10:30am Foege Auditorium*
    The new IRB application form Wed, Oct 5 9:00 to 10:00am Harborview R & T Auditorium
    The new IRB application form Fri, Oct 14 9:00 to 10:00am Tower Auditorium*
    Conversion of existing IRB applications Thu, Oct 13 8:30 to 9:30am Foege Auditorium*
    Conversion of existing IRB applications Thu, Oct 13 2:00 to 3:00pm Tower Auditorium*
    Conversion of existing IRB applications Fri, Oct 14 2:30 to 3:30pm Harborview R & T Auditorium
    Zipline: General overview Wed, Oct 5 11:30 to 1:00pm Bothell: Discovery Hall Rm 464
    Zipline: General overview October TBD Tacoma: TBD

    *Webcast


    End of Zipline Implementation (Rollout)

    All departments reviewed by IRB Committee J have been using Zipline for at least 3 months. The College of Engineering began using Zipline on September 1st. All other departments and programs that are reviewed by IRB Committee B must use Zipline as of September 15.

    On November 1st, all remaining departments and programs start using Zipline. That day will mark the end of new paper IRB applications at the University of Washington!

    We want to thank the Information School one last time for their whole-hearted support of Zipline by participating in multiple pre-implementation testing phases and by volunteering to be the "first adopter" of Zipline. Thank you also to the other campus participants in those early test phases.


    Want Someone to Do Your Conversion for You?

    The UW's Institute of Translational Health Sciences (ITHS) has a Research Coordination Center (RCC) that consists of a multidisciplinary team of research coordinators, regulatory specialists, research nurses, and study monitors who can support the design and conduct of clinical and translational research.

    The RCC is offering fee-based conversion assistance to investigators who need to convert their existing UW paper-based IRB applications to a Zipline application. The RCC and HSD have worked together to ensure that this service will efficiently meet the Zipline conversion requirements. The RCC will:

    • Work with your study team to identify the information needed to complete the conversion process
    • Complete the conversion application SmartForm and required supplements
    • Submit the completed conversion study documents to Zipline
    • Upload relevant study documents to the Zipline system
    • Be available for follow-up questions from HSD staff and IRB members

    HSD highly recommends this service, and is grateful to ITHS for its willingness to develop and provide this significant time-saving support to investigators. Contact ITHS through the Contact email form available on the ITHS Conversion webpage.


    What's Next?

    We will continue to update and add to our self-directed learning materials and Instructions on the Zipline Education page.

    We will also continue to closely analyze the Zipline-related experiences and comments of researchers, IRB members, and HSD staff over the next several months. We expect to implement a "patch" (i.e., some revisions and minor process changes) to Zipline and the IRB Protocol form sometime in mid-December, based on those experiences. It will be announced and described well in advance, through our long-standing monthly e-newsletter For the Record and on our webpage.

    Thank you for reading the zNews!

    People on a zipline

  • For the Record - September 7th - Zipline Updates and Roadshow

    Sep 9, 2016 at 5:00pm

    Zipline News

    Several Significant Events

    1. Zipline implementation expands to more departments.
    2. New learning materials are now available on the Zipline Education webpages
    3. The last issue of the zNews email series on September 14th
    4. This bi-weekly newsletter will end with the 16th issue on September 14. Each issue has a thematic focus on one element of the Zipline eIRB process and/or the new IRB Protocol form. They are archived on HSD's announcements page and should remain valuable resources for the coming year.

    5. The Zipline Roadshows are being repeated in September and October
    6. Because the remaining 75% of campus will begin using Zipline on September 15 or November 1, these in-person presentations are being repeated. They will include refreshed, up-to-date information based on the first three months of Zipline Implementation.

    Topic Date Time Location
    Zipline: The software & process Thu, Sept 29 2:30 to 3:30pm Harborview R & T Auditorium
    Zipline: The software & process Fri, Sept 30 10:30 to 11:30am Tower Auditorium
    Zipline: The software & process Thu, Oct 6 2:30 to 3:20pm Foege Auditorium
    The new IRB application form Tue, Oct 4 9:30 to 10:30am Foege Auditorium
    The new IRB application form Wed, Oct 5 9:00 to 10:00am Harborview R & T Auditorium
    The new IRB application form Fri, Oct 14 9:00 to 10:00am Tower Auditorium
    Conversion of existing IRB applications Thu, Oct 13 8:30 to 9:30am Foege Auditorium
    Conversion of existing IRB applications Thu, Oct 13 2:00 to 3:00pm Tower Auditorium
    Conversion of existing IRB applications Fri, Oct 14 2:30 to 3:30pm Harborview R & T Auditorium
    Zipline: General overview Wed, Oct 5 11:30 to 1:00pm Bothell: Discovery Hall Rm 464
    Zipline: General overview October TBD Tacoma: TBD

    Each topic will also be broadcast as a webinar and will be archived on HSD's website. More details will be available soon.


    HSD is Hiring!

    One of the nation's largest IRB offices

    HSD encourages interested individuals to apply for any of the following positions. Individuals with experience as a researcher, study coordinator, or research nurse are especially encouraged. These are permanent positions (not soft money).

    Requisition # HSD Title (Payroll Title)
    136009 Post Approval Monitor (Compliance Analyst) NEW POSITION
    136555 Metrics & Reporting Specialist (Program Operations Specialist)
    136876 Assistant Director for Researcher Support (Assistant Director) NEW POSITION
    136960 IRB Administrator (Compliance Analyst) (3 positions)

    For questions regarding the Post Approval Monitor position, contact Jason Malone, Assistant Director for Regulatory Affairs, jmmalone@uw.edu, 206-543-2254. All other questions can be directed to Karen Moe, HSD Director, at kemoe@uw.edu or 206-543-7246

    This is an exciting time to work at one of the nation's largest IRB offices. In addition to moving away from paper (no more stamping!), we are looking forward to innovative changes that will improve the IRB process because of the pending changes to the regulations and the pending requirement to use a single IRB for multi-site studies. HSD staff see every kind of research imaginable from a project documenting the blues music culture in Angola state prison to first-in-human clinical drug trials and everything in between!


    Collect Calls to HSD

    Effective Immediately

    HSD now has a phone line that can accept collect calls from research participants or others in the United States who have questions or complaints. This number is now part of the UW standard consent form template: 206-221-5940. There is no need to modify currently approved consent forms unless the addition of the number would be helpful for your subject population.

    This will ensure that subject populations who do not typically have cellphones and who do not have the money to pay for long distance calls can still contact HSD with any concerns or complaints. For example, this might be especially useful for research with homeless populations. We are looking into extending this to international calls as well. At present it is only available to subjects calling within the United States.


    FDA Guidance About Expanded Access

    Clinical Use of Investigational Drugs

    The Food and Drug Administration (FDA) released a Guidance document in June, entitled “Expanded Access to Investigational Drugs for Treatment Use Questions and Answers”. It provides practical information for physicians who may wish to use an investigational drug for clinical purposes instead of research.

    Contact HSD at hsdinfo@uw.edu or 206-543-0098 if you have any questions about a specific expanded access use situation or are not sure about whether you need IRB review. The UW Investigational Drug Services (IDS) at UW Medical Center (206-598-6054) and at Harborview (206-744-5448) are also useful sources of guidance and assistance.

  • zNews - HSD Zipline Rollout - Report of New Information

    Sep 1, 2016 at 8:57am
    Reminders...
    1. All academic units reviewed by IRB J as well as requests for review by WIRB or the Cancer Consortium IRB must use Zipline for new applications. Academic units reviewed by IRB Committee B begin using Zipline on September 1 (College of Engineering) or September 15 (All other units reviewed by IRB B).
    2. If you can't find someone in Zipline, it's likely because they have yet to register. Watch the video, or read the instructions on self-registration in Zipline, or cut and paste this information into an email and send it to the person who is ready to self-register.
    3. Until you've converted your paper file into a Zipline electronic file, there is nothing in Zipline to modify. You will need to use the paper Modification form until then.
    4. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline. Researchers whose departments are not yet using Zipline can choose to use this new application form for paper applications.
    5. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
    6. All forms necessary for using Zipline are now linked to the HSD forms page under "Z".
    7. If you need help with Zipline or the new forms, contact the Team Operations Lead associated with the IRB that reviews for your department, or contact hsdinfo@uw.edu.

    News Features

    Revised Zipline Implementation Schedule

    Due to the dissolution of Committee G, the rollout dates for the academic units reviewed by Committees A and D will be moved up from December 1st to November 1st, and the two week test period for one department has been eliminated.

    Also, the academic units formerly reviewed by G will be rolled into Zipline on November 1st, regardless of the committee to which they have been reassigned. See the updated rollout table on our website for the full list of academic units that will now be rolling into Zipline on November 1st.


    Report of New Information

    Regulatory requirement to report to the IRB. Researchers are required to report promptly to the IRB about a variety of events and new information. Some examples are: unanticipated problems involving risks to subjects or others; serious or continuing non-compliance; new information about the risks of the study (for example, from a drug manufacturer); and monitoring reports from study monitors or a Data and Safety Monitoring Board.

    The paper process before Zipline. Prior to Zipline, researchers fulfilled this obligation by sending HSD a completed Problem Report paper form.

    The Zipline reporting process. For studies that are in Zipline, this process is called Report of New Information. Though the process is now electronic rather than paper-based, it is very similar to the old paper process. See the table below for a comparison. Note that the Zipline process cannot be used for studies whose IRB applications are paper-based.

    Zipline Report of New Information (RNI) compared with paper Problem Report

    What is reported

    No changes except that reports from Data & Safety Monitoring Boards should now be submitted as a RNI instead of a Modification.

    See the table that describes what must be reported

    Forms to complete

    RNI SmartForm (a Zipline webform) and SUPPLEMENT: Report of New Information (an attached Word document).

    Information requested

    No changes.

    The order and wording of questions is different.

    Review process by HSD and IRB

    No changes, except that the communications happen within Zipline instead of by email.

    What to do if the new information requires a corrective or preventative action plan involving changes to the study

    No change - submit a Modification (through Zipline instead of on paper).

    What if the researcher wants to provide a follow-up report

    No change - submit another RNI (for the paper process, you would have submitted another Problem Report).

    What if the report is relevant to more than one study

    Submit a single RNI. The SmartForm allows you to indicate all of the studies to which the RNI applies.New

    The paper Problem Report required you to submit a separate report for each study.

    How to decide whether an event is related to the research activities

    The paper Problem Report asks for the researcher's opinion about whether the problem was: not related; possibly related or related to the research activities.New

    The Zipline RNI forms asks the researcher's opinion about whether the problem was: not related; probably related; or related.

    "Probably" means that it is more likely than not that the incident, experience, or outcome was caused by the research procedures


    Important Dates

    Departments Reviewed by IRB Committee B

    Zipline will be open for new applications from the College of Engineering on September 1st. All other departments that are reviewed by IRB Committee B will be required to enter new applications through Zipline on September 15th. See the UPDATED rollout schedule located here.

    Departments Formerly Reviewed by IRB Committee G

    All departments formerly reviewed by IRB Committee G will be required to enter new applications in to Zipline on November 1st. See the UPDATED rollout schedule located here.


    A Frequently Asked Question

    Q: Do I need to submit a RNI for minor non-compliance?

    A: No. Human subjects regulations require only that serious or continuing types of non-compliance must be promptly reported to the IRB. However, some minor compliance events may also result in a breach of confidentiality, unanticipated, or other event that must be reported.

    Non-compliance: An action or omission by the researcher that is inconsistent with the following:

    • The ethical principles of human subjects research as described in the Belmont Report
    • Federal, state, and/or local regulations application to human subjects research under the jurisdiction of the UW IRB
    • UW policies and procedures governing human subjects research, or
    • The research activities as approved by the UW IRB, including any IRB requirements or determinations.

    Serious non-compliance: Non-compliance which did or could have:

    • Significantly increased risks to, or jeopardized the safety, welfare, and/or rights or subjects or others
    • Significantly decreased potential benefits, or
    • Compromises the scientific integrity of the study such that important conclusions can no longer be reached.

    Conducting non-exempt human subjects research without any prospective IRB approval is always considered serious non-compliance.

    Continuing non-compliance: A pattern of repeated non-compliance by the same investigator or the IRB that:

    • Suggests the likelihood that non-compliance will continue without intervention;
    • Represents a failure to respond to a request to resolve an episode of non-compliance or pattern of minor non-compliance; or
    • Increases the risk of serious non-compliance.

    Minor non-compliance: Non-compliance that is neither serious nor continuing.


    Zipline Sneak Peek

    Report of New Information

    This screen shot shows the activities that are available for an already-approved study, including the Report of New Information activity. Clicking on this button opens a simple SmartForm.

    See future issues of zNews for more sneak peeks of key screen shots!

     


     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    "RNI"

    This stands for Report of New Information, which is the Zipline activity that researchers use to report a variety of events to the IRB. Examples include: unanticipated problems, serious non-compliance, new risk information, reports from a monitoring board, subject complaints, etc.

  • zNews - HSD Zipline Rollout - Status Reports and Closures

    Aug 17, 2016 at 3:44pm
    Reminders...
    1. All academic units reviewed by IRB J as well as requests for review by WIRB or the Cancer Consortium IRB must use Zipline for new applications. The College of Engineering will roll into Zipline on September 1st, followed by all the academic units reviewed by Committee B on September 15th.
    2. If you can't find someone in Zipline, it's likely because they have yet to register. Watch the video, or read the instructions on self-registration in Zipline, or cut and paste this information into an email and send it to the person who is ready to self-register.
    3. Until you've converted your paper file into a Zipline electronic file, there is nothing in Zipline to modify. You will need to use the paper Modification form until then.
    4. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline. Researchers whose departments are not yet using Zipline can choose to use this new application form for paper applications.
    5. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
    6. All forms necessary for using Zipline are now linked to the HSD forms page under "Z".
    7. If you need help with Zipline or the new forms, contact the Team Operations Lead associated with the IRB that reviews for your department, or contact hsdinfo@uw.edu.

    News Features
    Status Reports and Closures

    Researchers are responsible for renewing their IRB approval before it expires. They are also responsible for informing the IRB when the research has been completed and the IRB application can be closed. At the UW, these processes have historically been called Status Reports and Closures. In Zipline, they are collectively called Continuing Review.

    Easier in ZiplineIt's Easy

    Continuing Review (Status Reports and Closures) is much easier in Zipline than with the old paper process. Less information and fewer attachments are required. Instead, the focus is on identifying anything that is new or has changed for the research since your initial IRB review (or the last Status Report). Researchers provide this information by completing the Continuing Review activity in Zipline and uploading the Zipline-specific Status Report. Unless something has happened in your study, the application is very short and easy to complete. See the table below for a comparison of the paper versus Zipline processes.

    Elements UW Paper Process Zipline Process
    Number of pages before answering the questions 7 pages Smart Form - 1 page Attached Status Report - 2 pages Total: 3 pages
    PI and study contact names, titles, contact information Required Already in Zipline
    Provide current funding information Required Already in Zipline
    Short research description Required Already in Zipline
    Short description of research progress Required Required
    Study consent forms (stamped) Required attachments Already in Zipline
    Copy of manuscripts, abstracts, or papers since last Status Report Required attachments Not required
    Subject numbers Required; complicated table Required; simple table
    Clarity About When to Close an IRB Application

    Close your IRB application by creating a Continuing Review in Zipline and uploading the Zipline-specific Statuslight bulb Report. Zipline's Continuing Review SmartForm makes it very easy to know whether you can close your IRB application. If you can check the first four boxes on Question 2, then your application will be closed because your human subjects research is considered to be completed (as defined by federal regulations).


    Revised Zipline Implementation Schedule

    Due to the dissolution of Committee G, the rollout dates for the academic units reviewed by Committees A and D will be moved up from December 1st to November 1st, and the two week test period for one department has been eliminated.

    Also, the academic units formerly reviewed by G will be rolled into Zipline on November 1st, regardless of the committee to which they have been reassigned. See the updated rollout table on our website for the full list of academic units that will now be rolling into Zipline on November 1st.


    Minor Updates to Zipline

    Effective August 11, 2016

    HSD has made minor changes to the Zipline SmartForms and to the IRB Protocol application form. This is a planned part of the overall Zipline implementation schedule, which allows us to address any issues discovered during the pilot phase of Zipline implementation.

    Zipline SmartForms

    • The requirement for department ancillary review has been removed.
    • The text of some questions and help "bubbles" have been revised for clarity.
    • There are no new questions, and no questions have been removed.

    IRB Protocol form

    • Hyper links to documents and information have been added.
    • A few questions have been revised for clarity - especially the questions about identifiability in the Procedures section.
    • One new question about identifiability has been added. No questions have been removed.

    Important Dates
    Departments Reviewed by IRB Committee B

    Zipline will be open for new applications from the College of Engineering on September 1st. All other departments that are reviewed by IRB Committee B will be required to enter new applications through Zipline on September 15th. See the UPDATED rollout schedule located here.

    Departments Formerly Reviewed by IRB Committee G

    All departments formerly reviewed by IRB Committee G will be required to enter new applications in to Zipline on November 1st. See the UPDATED rollout schedule located here.


    A Frequently Asked Question

    Q: What should I do on the Continuing Review SmartForm if my subject numbers are more complicated than the table on the SmartForm can handle (see the screen shot below)? How do I communicate this to the IRB?

    A: The short Status Report form that you are required to complete and attach to the Continuing Review SmartForm has a table that is more flexible and a text box for explanations or additional information.


    Zipline Sneak Peek
    Enrollment totals

    This screen shot shows the first question on the Continuing Review SmartForm. It asks for the number of subjects in the study.

    Study milestone

    This screen shot shows the second question on the Continuing Review SmartForm. If you check all four of the first four boxes, your IRB application can be closed.

    See future issues of zNews for more sneak peeks of key screen shots!


    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    "Continuing Review"

    This refers to the federal requirement that all IRB-approved studies need to be periodically re-reviewed by the IRB. IRB approval is typically granted for one or three years, to ensure that this continuing review occurs and IRB approval is renewed.

    For years, researchers have used the paper form called the Status Report to (1) request renewal of their IRB approval or (2) inform the IRB that their research has been completed and the IRB application can be closed. Now these process will occur in Zipline, where it is called Continuing Review.

  • zNews - HSD Zipline Rollout - Updates to Zipline

    Aug 9, 2016 at 9:38am
    Reminders...
    1. All academic units reviewed by IRB J as well as requests for review by WIRB or the Cancer Consortium IRB must use Zipline for new applications.
    2. If you can't find someone in Zipline, it's likely because they have yet to register. Watch the video, or read the instructions on self-registration in Zipline, or cut and paste this information into an email and send it to the person who is ready to self-register.
    3. Until you've converted your paper file into a Zipline electronic file, there is nothing in Zipline to modify. You will need to use the paper Modification form until then.
    4. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline. Researchers whose departments are not yet using Zipline can choose to use this new application form for paper applications.
    5. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
    6. All forms necessary for using Zipline are now linked to the HSD forms page under "Z".
    7. If you need help with Zipline or the new forms, contact the Team Operations Lead associated with the IRB that reviews for your department, or contact hsdinfo@uw.edu.

    Revised Zipline Implementation Schedule

    Due to the dissolution of Committee G, the rollout dates for the academic units reviewed by Committees A and D will be moved up from December 1st to November 1st, and the two week test period for one department has been eliminated.

    Also, the academic units formerly reviewed by G will be rolled into Zipline on November 1st, regardless of the committee to which they have been reassigned. See the updated rollout table on our website for the full list of academic units that will now be rolling into Zipline on November 1st.

     


     

    Department Sign-Off ("Ancillary Review")

    Effective August 1, 2016

    The change. Departments will no longer be required to sign off on new IRB applications submitted through the Zipline eIRB system. The ink signature on paper applications will continue to be required until November 1st, when new paper applications will no longer be accepted by HSD.

    The rationale. The requirement to assess researcher qualifications and resources in a way that is appropriate for the research risk level is accomplished through other existing mechanisms, which makes the department sign-off redundant. For example, most research that involves more than minimal risk is externally funded. Funding agencies typically use a rigorous peer-review process that considers the PI's qualifications and resources. In addition, departments sign off on grant applications before they are submitted.

    Continued assistance to departments, if necessary. A few departments rely on the sign-off process to trigger a formal review and/or to help them track the department's research portfolio. There is an easy way for departments to use Zipline to continue this process, without making it a requirement for IRB approval. Contact HSD through the Team Operations Lead that supports your department or through hsdinfo@uw.edu for information.


    Minor Updates to Zipline

    Effective Mid August, 2016

    HSD is making some minor changes to the Zipline SmartForms and to the IRB Protocol application form. This is a planned part of the overall Zipline implementation schedule, which allows us to address any issues discovered during the pilot phase of Zipline implementation. Watch the featured news on the Zipline login page for the exact date.

    Zipline SmartForms

    • The requirement for department ancillary review will be removed.
    • The text of some questions and help "bubbles" will be revised for clarity.
    • There are no new questions, and no questions have been removed.

    IRB Protocol form

    • Hyper links to documents and information will be added.
    • A few questions will be revised for clarity - especially the questions about identifiability in the Procedures section.
    • One new question about identifiability has been added. No questions have been removed.

    Important Dates

    Departments Reviewed by IRB Committee B

    Zipline will be open for new applications from the College of Engineering on September 1st. All other departments that are reviewed by IRB Committee B will be required to enter new applications through Zipline on September 15th. See the UPDATED rollout schedule located here.

    Departments Formerly Reviewed by IRB Committee G

    All departments formerly reviewed by IRB Committee G will be required to enter new applications in to Zipline on November 1st. See the UPDATED rollout schedule located here.


    A Frequently Asked Question

    Q: The departments reviewed by IRB Committees A and D were originally scheduled to start using Zipline for new applications on December 1 (School of Nursing; Department of Family Medicine) or December 15 (all other departments reviewed by IRB A or D). Now that the Zipline implementation schedule has been revised, when will these departments start using Zipline for new applications?

    A: November 1


    Zipline Sneak Peek
    Manage Ancillary Review

    This screen shot shows the Manage Ancillary Reviews activity in the "My Current Actions" menu, which is now required ONLY for students, residents, fellows and post-docs who are requesting the mandatory sign-off of their faculty advisors.

    See future issues of zNews for more sneak peeks of key screen shots!

     


     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    "Help bubbles"

    This refers to the short, context-specific help that is Question marklocated throughout the Zipline SmartForms. These helpful hints, explanations, and definitions are indicated with a small question mark bubble symbol. They are especially useful because they do not require the researcher to navigate away from the Zipline SmartForm or to open a document. Simply click on the help bubble in Zipline (Icon to the right) to reveal the text.

  • For the Record - August 1st - Farewell to IRB Committee G

    Aug 1, 2016 at 4:05pm

    A Fond Farewell to IRB Committee G

    Effective September 1, 2016

    IRB Committee G is being disbanded, effective September 1, 2016.

    Rationale. IRB Committee G reviews IRB applications for social/behavioral research. In the past year, the number of social/behavioral applications requiring review by the full convened IRB has dropped dramatically.

    • 31% of IRB G's meetings in 2016 have been cancelled because there were no applications to review.
    • The number of items reviewed by the full IRB G committee has averaged only 37% of the number of items reviewed by the other UW IRB committees.

    This is the direct result of HSD's multi-faceted efforts at ensuring that applications receive the appropriate type and level of review. Most social/behavioral applications meet the federal criteria for exempt status or minimal risk review; nevertheless, HSD sent many of these applications to the full IRB Committee in the past.

    No layoffs. No HSD staff are being laid off. The Team G staff are being re-assigned to the teams that support the other IRBs.

    Departments reviewed by G. The academic departments that are currently assigned to G for all types of review will be assigned to one of the other IRBs and staff teams. See the Contact Finder PDF for a complete list of these departments and their new team assignments. For example:

    Department Currently Reviewed by G

    New IRB and Team Assignment

    Alcohol & Drug Abuse Institute

    J

    College of Arts & Sciences (except Psychology)

    A

    College of Education, Tacoma Education, Bothell Education

    D

    Psychology

    B

    Psychiatry and Behavioral Sciences

    J

    Speech and Hearing Sciences

    D

    Review turn-around time. We expect little or no effect of this change on review turn-around times, because (1) each of the other IRBs is absorbing only a very small number of additional full board items; and (2) the HSD staff that currently do the exempt and minimal risk reviews for G will continue to do those reviews under the umbrella of a new HSD team. A few of the IRB members from G will move to one of the other IRBs.

    Zipline rollout for "G" departments. See the news item below for information about when the departments who have been reviewed by IRB G will begin using the new eIRB system called Zipline.

    THANK YOU to the many faculty members who served on the IRB Committee G since its inception in May 2001, and to the HSD staff who have supported it.

    ***The news items below are important announcements about Zipline that will be repeated in the August 3rd edition of HSD's zNews email.***

    Revised Zipline Implementation Schedule

    Effective Immediately

    Due to the dissolution of Committee G, the rollout dates for the academic units reviewed by Committees A and D will be moved up from December 1st to November 1st, and the two week test period for one department has been eliminated.

    Also, the academic units formerly reviewed by G will be rolled into Zipline on November 1st, regardless of the committee to which they have been reassigned. See the updated rollout table on our website for the full list of academic units that will now be rolling into Zipline on November 1st.


    Department Sign-Off ("Ancillary Review")

    Effective August 1, 2016

    The change. Departments will no longer be required to sign off on new IRB applications submitted through the Zipline eIRB system. The ink signature on paper applications will continue to be required until November 1st, when new paper applications will no longer be accepted by HSD.

    The rationale. The requirement to assess researcher qualifications and resources in a way that is appropriate for the research risk level is accomplished through other existing mechanisms, which makes the department sign-off redundant. For example, most research that involves more than minimal risk is externally funded. Funding agencies typically use a rigorous peer-review process that considers the PI's qualifications and resources. In addition, departments sign off on grant applications before they are submitted.

    Continued assistance to departments, if necessary. A few departments rely on the sign-off process to trigger a formal review and/or to help them track the department's research portfolio. There is an easy way for departments to use Zipline to continue this process, without making it a requirement for IRB approval. Contact HSD through the Team Operations Lead that supports your department or through hsdinfo@uw.edu for information.


    Minor Updates to Zipline

    Effective Mid August, 2016

    HSD is making some minor changes to the Zipline SmartForms and to the IRB Protocol application form. This is a planned part of the overall Zipline implementation schedule, which allows us to address any issues discovered during the pilot phase of Zipline implementation. Watch the featured news on the Zipline login page for the exact date.

    Zipline SmartForms

    • The requirement for department ancillary review will be removed.
    • The text of some questions and help "bubbles" will be revised for clarity.
    • There are no new questions, and no questions have been removed.

    IRB Protocol form

    • Hyper links to documents and information will be added.
    • A few questions will be revised for clarity - especially the questions about identifiability in the Procedures section.
    • One new question about identifiability has been added. No questions have been removed.
  • zNews - HSD Zipline Rollout - Modifications

    Jul 20, 2016 at 3:00pm
    Reminders...
    1. The pilot phase of Zipline began May 31st, when IRB J began accepting new applications from the Information School, and all requests for review by WIRB now go through Zipline. On June 15, all other academic units reviewed by IRB J began using Zipline. On July 1st, requests for review by the Cancer Consortium IRB started going through Zipline.
    2. NEW If you can't find someone in Zipline, it's likely because they have yet to register. Watch the video, or read the instructions on self-registration in Zipline.
    3. NEW Until you've converted your paper file into a Zipline electronic file, there is nothing in Zipline to modify. You will need to use the paper Modification form until then.
    4. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline. Researchers whose departments are not yet using Zipline can choose to use this new application form for paper applications.
    5. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
    6. Copies of the webinars and talks given by Karen Moe and the Regulatory Affairs team are available on the Zipline News page and the Zipline General Help page.
    7. All forms necessary for using Zipline are now linked to the HSD forms page under "Z".
    8. If you need help with Zipline or the new forms, contact the Team Operations Lead associated with the IRB that reviews for your department, or contact hsdinfo@uw.edu.

    News Features

    Modifications in Zipline

    Modifications in Zipline are very different than the paper process. One of the best benefits of an electronic system isChange sign that the information provided to HSD can later be edited directly; all modifications are made to the originally submitted documents and SmartForms! In contrast to our paper process, this means that your application in Zipline will always contain the most current information about the study, and no "outdated" information. Zipline keeps a history of all changes, but these are separated from the rest of the file, so it is clear to reviewers and researchers which information is relevant and current.

     

    Key Information about Modifications in Zipline

    1.

    The application will always contain the most recently approved information; so no need to dig through many modifications to piece together the current snapshot of your study!

    2.

    Only one modification of each type (see below) can be submitted at a time.

    3.

    The names of the Principal Investigator (PI) and the faculty advisor (if any) are the only names listed in the application; the study team addendum will collect "study role" information for the other team members, but no names. This means that the only time a modification is required for making team member changes is when the PI or faculty advisor changes, or when the study roles change.

    4.

    Access to the application for other study team members can be managed through an activity called Manage Study Team. This activity is available throughout the life of the study and does not require a modification to update.

    5.

    Zipline modifications can only be created for those studies that exist in Zipline; if your study currently exists on paper, you are required to submit paper modifications until your study is converted in Zipline.

     

    Making Changes to the Study - Creating a New Modification

    For studies that are active and approved, there will be a button under My Current Actions in the study workspace that will allow you to create a modification.

    Create Modification

     

    Types or "Scope" of Modification

    There are two different modification types; you can have one modification of each type under review at any one time in the system. When you create a new modification, you will see the screen below. Note that there are two options under "Modification Scope".

    Modification Scope

    Modification to other parts of the study include changes to anything besides study roles. For example, this would include updating the IRB Protocol, consent forms, and Zipline Smart Forms.

    Study team roles modifications are very limited in scope. This type of modification allows you to edit only the StudyPeriscope Roles Addendum that describes team members by position/descriptive title rather than name. IMPORTANT: HSD does not require modifications for personnel (name) changes other than the Principal Investigator and/or faculty advisors. However, if a study role changes (e.g. a licensed practitioner is added to the study team), information about the role change is required via modification.

    HSD recognizes that many people are often involved in the creation/modification of human subjects applications. Zipline has an activity called Manage Study Team that allows you to manage access to the application without having to add a person's name to the IRB application.

     

    Modifying the Study Roles Vs. Updating the Person Filling a Role

    In Zipline, information about the study team is provided in two different locations - in the Study Roles Addendum, and in the Manage Study Team activity:

     

    The Study Roles Addendum

    Manage Study Team Activity

    What information is captured?

    Identifies the roles on your study team, such as study coordinator, interpreter, or licensed psychologist and does not include any names

    Lists the names of any study team members that need the ability to access and edit the Zipline IRB application

    Do changes to it require a study modification?

    Yes, because it is considered a part of the application that the IRB reviews. Therefore, a study modification is required if there is a change

    No, because it is not considered a part of the application. Changes can be made by any team member at any time without a study modification

    Where do I make a change?

    The Study Roles Addendum form, which is attached to the Study Team Roles page in the Zipline SmartForms

    This is available as an activity in the study workspace

     

    Modifications are Allowed for all Application Types

    With the paper-based process, modifications are allowed only for studies that receive IRB approval, either through the expedited process or from the convened IRB. Though studies that receive a determination such as "Exempt Status" or "Not Human Subjects Research" do need to inform HSD of any changes to the study that may require IRB review, this notification is accomplished by submitting a new application (instead of a modification).

    In contrast, the Zipline system allows modifications to studies that receive determination such as "Exempt or "Not Human Subjects Research." This means that instead of submitting a brand new application, you can instead submit a modification to your existing study if the change may require IRB review.

    Determination

    Modification allowed on paper?

    Modification allowed in Zipline?

    IRB Approval (expedited or from convened IRB)

    YES

    YES

    Exempt Status Determination

    NO

    YES

    Not Human Subjects Research Determination

    NO

    YES

    Not Research Determination

    NO

    YES

     


    Pardon Our Dust

    Safety Cone
    Pardon our dust for another few weeks while we finish making all of the Zipline-related changes to the HSD website and ensure consistency of information across web pages and documents.


    Important Dates

    Departments Reviewed by IRB Committee B

    Zipline will be open for new applications from the College of Engineering on September 1st. All other departments that are reviewed by IRB Committee B will be required to enter new applications through Zipline on September 15th. See the rollout schedule located here.


    Frequently Asked Questions

    Q: What if I discover something else I need to change while I have a Modification already in pre-review?

    A: There are several ways that you can add something to a Modification that is already in pre-review, but the first thing you should always do is contact the HSD Team Operations Lead for your department or the team member assigned to your study to let them know that you need to make an additional change. (1) Once you've notified HSD, you can use the Withdraw activity to return your Modification to the pre-submission state. Then make your updates and re-submit the modification to HSD. (2) You may also request that your HSD contact send you a "Request for Clarification" in Zipline, and you can add your updates then. (3) The last option is to wait until the review of the current Modification is complete, and then submit another Modification.

    Q: How do I modify my current paper-based study in Zipline?

    A: You cannot submit Modifications in Zipline unless your study already exists in Zipline. In other words, you can submit modifications in Zipline only after your paper-based application has been converted into Zipline at the time of your next Continuing Review (Status Report). For more information on conversions see our Zipline Conversions webpage.

     


    Zipline Sneak Peek
    Create Modification

    When you are ready to create a Modification or submit a Status Report (Continuing Review) in Zipline for an already-approved study, click the "Create Modification/CR" button in the left hand navigation of the study workspace.

    Modification Types

    You will then be asked to choose which type of Modification you are submitting.

    See future issues of zNews for more sneak peeks of key screen shots!

     


     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    "Study Roles"

    In order to reduce the number of "nuisance" modifications, HSD instituted a flexibility policy in 2014 allowing researchers to change staff to specific study roles by confirming their qualifications but not mentioning their names. In Zipline, the distinction between "Study Roles" and the names of individuals filling those roles is even sharper, because researchers are required to submit a modification to change study roles only when the role itself changes. The ZIPLINE ADDENDUM: Study Roles is a smart PDF form that tracks roles and qualifications for that role, rather than the name of the person. So if a staff member who is obtaining subject consent is replaced by a Licensed Nurse Practitioner who will obtain consent AND perform research procedures a modification is necessary. However, if the staff member obtaining consent leaves the study and is replaced by another person obtaining consent, a Modification is not required.

  • zNews - HSD Zipline Rollout - Communication Within Zipline

    Jul 7, 2016 at 9:22am
    Reminders...
    1. The pilot phase of Zipline began May 31st, when IRB J began accepting new applications from the Information School, and all requests for review by WIRB now go through Zipline. On June 15, all other academic units reviewed by IRB J begin using Zipline. On July 1st, requests for review by the Cancer Consortium IRB started going through Zipline.
    2. If you can't find someone in Zipline, it's likely because they have yet to register. Watch the video, or read the instructions on self-registration in Zipline.
    3. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline. Researchers whose departments are not yet using Zipline can choose to use this new application form for paper applications.
    4. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
    5. Copies of the webinars and talks given by Karen Moe and the Regulatory Affairs team are available on the Zipline News page and the Zipline General Help page page.
    6. All forms necessary for using Zipline are now linked to the HSD forms page under "Z".
    7. If you need help with Zipline or the new forms, contact the Team Operations Lead associated with the IRB that reviews for your department, or contact hsdinfo@uw.edu.

    News Features

    "Back and Forth" Between Researchers and the IRB

    One of the biggest differences between the Zipline system and the paper-based IRB system is that the "back andTin can telephones forth" between researchers and the IRB about a specific application occurs largely within Zipline and by revising the documents in Zipline. The table below summarizes the key differences between the two systems in this important communication process. After the table, we provide tips for successful communication about specific applications using Zipline. NOTE: Questions that are not specific to an application that is under review should continue to be directed to hsdinfo@uw.edu or the HSD staff Team Operations Lead for your department.

    Event

    Paper-Based IRB system

    Zipline IRB system

    Application has been assigned to an IRB

    This status (and which IRB) is not known unless the PI specifically contacts HSD and asks

    Submission "workspace"; displays which IRB has been assigned and visual status of Pre-Review

    Application has been assigned to a specific HSD staff person to do a pre-review (screening) and to shepherd the application through the review process

    This status (and which staff person) is not known unless the PI specifically contacts HSD and asks

    Submission "workspace" displays which HSD staff person has been assigned ("IRB Coordinator") and visual status of Pre-Review

    Notification that a screening or IRB review has occurred and is available for the PI's response

    Email notice, to

    • Principal investigator (PI)
    • Primary contact

    Email notice, to

    • PI
    • Primary contact
    • PI Proxy (can be more than 1)

    Location of screening and review letters

    Email attachment

    Zipline History tab

    How point-by-point response letter from PI is sent to HSD

    Printed copy delivered to HSD
    (optional: email)

    Attached to Supporting Documents section of Submit Response Zipline screen (see Zipline Sneak Peek, below)

    How revised consent forms and other study documents are communicated

    PI sends multiple printed copies of "tracked changes" and "clean" versions of revised documents to HSD

    PI edits the Zipline application by replacing the originally submitted document with a "tracked changes" version in the same location in Zipline

    How new or clarifying information relevant to the application is communicated

    PI sends the information in an email or mails/delivers a document containing the new information to HSD

    PI must revise the relevant application document to include the new or revised information. Example: revise the IRB Protocol Form to include correct subject numbers.

    • PI may also send the information in a letter attached to the Supporting Documents section of the Submit Response Zipline screen.

    How approval is communicated

    Email from HSD:

    • PI
    • Primary contact

    And IRB signature in a box on a printed copy of the application form sent to:

    • Primary contact.
    1. Email notice, with link to approval letter to:
      • PI
      • Primary contact
      • PI proxy (can be more than 1)
    2. And approval letter in Zipline History tab and Study workspace, visible to:
      • PI
      • Primary contact
      • PI proxy
      • Study team members
      • Guests

    Keys to Successful Communication in the Zipline IRB System

    The following tips will help ensure that your communication "back and forth" with HSD and the IRB is smooth andkeys to success efficient.

    1. Submission and Study workspace: Become familiar with the submission and study "workspace" area and the wealth of information it provides about your study overall and about any specific application (e.g., initial application modification) for your study.
    2.  

      See Navigating within a Submission Workspace, on pages 10-12 of the Manual: Introduction to Zipline.

       

    3. Graphic of application status: Become familiar with the meaning of the status states displayed on the graphic in your study workspace.
    4. Zipline workflow diagram

       

      See:

       

    5. All new or changed information must be incorporated into your application documents. Information described in an email or a response letter must be incorporated into the relevant application documents.
    6.  

      See the Online Tutorial or Instructions in the Responding to Requests for Clarification or Modification section of the webpage Zipline Help for Researchers.

       

    7. Where to put revised documents. Be sure to attach revised documents to the correct place in Zipline, by replacing the original version.
    8.  

      See:

       


    For the Record Returns

    For the Record, HSD's regular monthly newsletter returned on July 5th. For the Record is HSD's primary method of communicating to campus about non-Zipline related changes in policy, processes, forms, and regulations. zNews will continue to be published bi-weekly through the end of August.


    Pardon Our Dust

    Safety Cone
    Pardon our dust for another few weeks while we finish making all of the Zipline-related changes to the HSD website and ensure consistency of information across web pages and documents.


    Important Dates

    Departments Reviewed by IRB Committee B

    Zipline will be open for new applications from the College of Engineering on September 1st. The remainder of departments that are reviewed by IRB Committee B will be able to enter new applications through Zipline on September 15th. See the rollout schedule located here.


    A Frequently Asked Question

    Q: Does the concept of "communication within Zipline" mean that I can't phone or email the HSD staff person assigned to my application?

    A: No. Please feel free to continue to work with your HSD staff person in whatever way works best for you. However, any information that is relevant to your application must be added to your Zipline application; it cannot exist solely in an email.


    Zipline Sneak Peek

    When responding to a review, it is important to attach any revised documents to the correct place in Zipline. Attaching them to the wrong place will slow the review process, because HSD cannot continue the review until you have moved the attachment to the correct place.

    In general, the only document that should be attached to the Supporting Documents section of the Submit Response screen is your point-by-point response to a HSD or IRB review letter. See the screen shot below:

    Submit Response

    For example, if the IRB review requires you to revise your consent form, do not attach the revised consent form to the Supporting Documents section of the Submit Response screen. Instead, replace your original consent form with the revised consent form at its location on the Consent Forms and Recruitment Materials SmartForm (see the screen shot below). Similarly, if you need to revise your IRB Protocol form, replace the original IRB Protocol form at its location under Question 10 on the Basic Information SmartForm.

    Consent Forms and Recruitment Materials

    See future issues of zNews for more sneak peeks of key screen shots!

     


     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    New terms that are used to refer to your application status in Zipline

    These terms are used on the graphic near the top of the page in your study's Zipline workspace.

    Paper system

    Zipline system

    What it means

    Screening
    (as in "Screening Letter")

    Clarification Requested (Pre-review)

    HSD staff have screened ("pre-reviewed") your application and require clarifications or more information before your application can be sent to the IRB for review.

    Deferral

    The graphic disappears but the purple application status button in the upper left hand corner reads "Deferred"

    The IRB is unable to approve the research because it does not have the information or changes necessary in order to meet the criteria for approval. You provide the requested information or changes by editing your application and then sending the edits back to the IRB using the SUBMIT RESPONSE activity.

    Conditional Approval

    Modifications Required to Secure Approval

    The IRB has determined that the applicable criteria for IRB approval have been met, based on the assumption that specific conditions (which may include specific changes) will be met by the researcher. These changes are made by editing your application and then sending the edits back to the IRB with the SUBMIT RESPONSE activity. Do not use the activity called CREATE MODIFICATION / CR. Modifications can be submitted for a study only after the study has been approved.

  • For the Record - July 5, 2016 - Welcome Back!

    Jul 6, 2016 at 1:43pm

    Welcome Back

    To HSD's regular monthly e-newsletter

    For the Record is HSD's primary method of communicating changes in policy, processes, forms, and regulations to campus. It is sent on the first Monday of each month. Our goals are to make each news item concise, easy to read, and of high value.

    We paused publication for a few months while we focused on our zNews, a special bi-weekly newsletter with detailed information about our new eIRB system called Zipline. The zNews will continue through the end of August. All published issues are available on the announcements page of HSD's website.

    For the Record returns with a bang! Described below are many significant policy changes at the UW, state, and federal level - including a federal policy about the IRB review of multi-site research that is being described as a "paradigm shift in IRB review".


    Zipline Progress Report

    Implementation has started!

    Zipline began its phased roll out May 31, 2016! All departments that are reviewed by IRB Committee J are now able to submit new IRB applications using the electronic system, and new IRB Protocol form. Many thanks to the iSchool for being our very first department to submit. Studies that are going to WIRB are also being entered into Zipline!

    Zipline will get a small update at the end of August that will include feedback from from our initial users: both HSD and researchers. Watch for the announcements below the Zipline login. Here, we will be posting updates, changes, and improvements. Right now this space is being used to let you know which academic departments are currently allowed to submit new applications in Zipline.

    Keep reading zNews for important information on Zipline topics and dates!

     


    Destruction of Identifiers or Identifiable Data

    Major policy change
    Implemented May 31, 2016

    The change: Identifiers that are collected with research data are considered to be part of those data and therefore must be retained for the applicable Washington State records retention period. (See UW Records Management, records retention schedule, and UW Medicine Records Management, records retention schedule.)

    Reason for the change: In early 2016, the UW Records Management offices obtained clarification from Washington State authorities about this issue. This clarification took effect on May 31, 2016 for all new human subjects studies. Studies that were approved before May 31st were "grandfathered" and can continue to handle identifiers in the manner described in their approved IRB applications, consent forms, and Confidentiality Agreements.

    Impacts:

    • New IRB applications and consent forms: If you wish to destroy identifiers, the destruction date you provide in these documents should agree with the retention requirement outlined by the UW or UW Medicine records retention schedules.
    • New Confidentiality Agreements: You must use the most recent version of the Agreement Template which no longer asks for an identifier destruction date. If you use older versions of the template, you may be asked to re-do the Agreement - including obtaining all signatures.
    • Existing IRB applications, consent forms,and Confidentiality Agreements: No changes are necessary.
    • Data security protections: Researchers have commonly relied on destruction of identifiers as a major component of protecting the security and confidentiality of research participant data. Now researchers will need to focus on other methods, such as strong passwords, encryption, physical security, and coding (i.e., separation of identifiers from data).
    • Closing an IRB application: Many researchers mistakenly believe that an IRB application cannot be closed as long as the data collected by the study are individually identifiable. Instead, the key issue is whether the identifiable data are still being analyzed and used for the purposes of the specific study. See HSD's SOP Closure for more information.

    Questions? Contact hsdinfo@uw.edu or your department's Team Operations Lead.

     


    What is Research?

    New Guidance, Revised Definitions
    Implemented May 31, 2016

    In response to campus requests, HSD has created a new GUIDANCE: Is it Research? document about how to determine whether a planned activity is or is not research as defined by the federal human subjects regulations. It provides specific details and many examples, and expands upon the information in the WORKSHEET: Human Subjects Research.

    Both the Guidance and the Worksheet include revised HSD definitions of specific terms such as "generalizable" that are key parts of deciding whether an activity is "research". We hope that these revised definitions are easier to understand and apply.

     


    Genomic Data Sharing

    Major policy change
    Implemented May 31, 2016

    Background

    In 2015, the National Institutes of Health (NIH) implemented the NIH Policy on Genomic Data Sharing (GDS). These requirements for NIH funded research are an expansion of the 2008 NIH policy requiring submission of most genomic data to a NIH database. An informative NIH website provides complete details.

    Change

    NIH has provided additional guidance about the GDS policy. These have now been incorporated into HSD's policies about the criteria for allowing genomic data to be sent to a NIH database for broad sharing and other research uses. The most significant change is the new provision for granting exceptions to the consent-related criteria. See the WORKSHEET: Consent Requirements and Expectations for Genomic Data Sharing and GUIDANCE: Genomic Data Sharing.

     


    NIH Policy on Single IRB Review of Multi-Site Studies

    Major new policy
    Implementation date: May 25, 2017

    NIH released a new policy on June 22, 2016, that will require the use of a single IRB (sIRB) for the review of all domestic sites participating in any NIH-funded multi-site research that is funded by grants or contracts submitted to NIH on or after May 25, 2017.

    This policy is intended to promote effective, efficient IRB review of multi-site research while eliminating the unnecessary repetitions of those reviews across sites. As NIH stated, "The sIRB policy will be a paradigm shift in IRB review". NIH has already begun preparing resources to assist the research community in preparing for the implementation of the policy:

    This policy must be considered by all UW researchers who expect to:

    • Submit a grant or contract application to NIH on or after May 25, 2017 as the Lead Principal Investigator or as the Coordinating Center for a multi-site study, or
    • Participate as a site in a multi-site study funded by a grant or contract submitted to NIH on or after May 25, 2017.

    HSD and the Office of Research will be working as quickly as possible with the Institute of Translational Health Sciences, the Office of Sponsored Programs, Grant and Contract Accounting, and other UW offices to develop the processes, cost information, IRB structure, and other elements that will be required to comply with this very significant policy change. Question? Contact HSD's Director, Karen Moe, at kemoe@uw.edu or 206-543-7246.

     


    HSD's Training Completion Confirmation Tool

    Reminder, pending removal
    September 1, 2016

    HSD has extended the date for retiring our training documentation lookup tool to September 1, 2016, which contains records of human subjects training taken before November 1, 2015. The tool will be available for documentation download until September 1, 2016, at which point it will be taken off our website. If you took an in-person training prior to HSD's use of CITI, you should obtain and save documentation from our lookup tool as soon as possible.

    The certificate of completion provided to you directly from the source of training (ex CITI or NIH PHRP) should be retained by you indefinitely and provided as documentation of training to any sponsors or collaborating institutions that require the training.

     


    Finding HSD Forms and Documents

    Paper vs Zipline
    Implementation May 31, 2016

    While Zipline is rolling out to campus, HSD needs to employ two different processes: paper and electronic. In order to differentiate documents for use with each process, their titles have been prefaced with either "PAPER" or "ZIPLINE" or both, if they are to be used with either system. This change applies mostly to forms.

    On the alphabetical list of documents on our website, the forms now fall under "P" or "Z". But on the Policies, Procedures and Guidance page, all documents are still organized topically.

    This change is temporary, as all of campus should be on Zipline by the end of this year. At that time, all "Paper" forms will be removed!

     


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. Please always use the latest forms and documents from our website. We use this newsletter to alert you to those new documents, and welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Zipline Forms
    Document(s) NEW: ZIPLINE APPLICATION: IRB Protocol; ZIPLINE APPLICATION: IRB Protool, No Contact with Subjects; ZIPILNE APPLICATION: Status Report, Renew or Close; ZIPLINE SUPPLEMENT: Department of Defense Involvement; ZIPLINE SUPPLEMENT: Devices; ZIPLINE SUPPLEMENT: Drugs, Biologics, Botanicals, Supplements; ZIPLINE SUPPLEMENT: Exception from Informed Consent for Emergency Research (EFIC); ZIPLINE SUPPLEMENT: Genomic Data Sharing; ZIPLINE SUPPLEMENT: Participant Results Sharing; ZIPLINE SUPPLEMENT: Participating Site in Multi-Site Research; ZIPLINE SUPPLEMENT: RNI (Report of New Information)
    Description New forms and supplements to be used only with Zipline applications.
    Expected impact High
    Related changes Forms for the paper process have been prefixed by the word "Paper"
    Link for more information See the news article or the documents linked above.
    Implementation date

    May 31, 2016

     

    Topic Zipline Conversions
    Document(s) NEW: ZIPLINE APPLICATION: Status Report, Conversion Study; LETTER: Conversion, 16 Week Notice; LETTER: Conversion, 10 Week Notice; LETTER: Conversion, 6 Week Notice; LETTER: Conversion, Final Notice; LETTER: Conversion 3yr Reminder
    Description Web page and documents specific to converting your paper-based study into Zipline
    Expected impact High
    Related changes None
    Link for more information Zipline Conversions Web Page
    Implementation date

    May 31, 2016

     

    Topic WIRB Studies
    Document(s) UPDATED and NEW: INSTRUCTIONS: Submitting to WIRB; ZIPLINE SOP External IRB (WIRB) Review - HSD Procedures; ZIPLINE SOP External IRB (WIRB) Review - Researcher Procedures; ZIPLINE WIRB FAQ; ZIPLINE WIRB Process Diagram; ZIPLINE WORKSHEET: External IRB (WIRB) Eligibility
    Description Studies that are going to WIRB are now entered into Zipline
    Expected impact High
    Related changes Outdated documents removed
    Link for more information External IRB (WIRB) Presentation
    Implementation date

    May 31, 2016

     

    Topic CC-IRB Studies
    Document(s) UPDATED and NEW:  ZIPLINE SOP External IRB (CC-IRB) Review - HSD Procedures; ZIPLINE SOP External IRB (CC-IRB) Review - Researcher Procedures; ZIPLINE WORKSHEET: External IRB (CC-IRB) Eligibility
    Description Studies that are going to CC-IRB are now entered into Zipline
    Expected impact High
    Related changes Outdated documents removed
    Link for more information External IRB (CC-IRB) Presentation (PDF of slides)
    Implementation date

    July 1, 2016

  • zNews - HSD Zipline Rollout - Ancillary Review (Updates to Ancillary Review Requirements 8/1)

    Jun 22, 2016 at 1:15pm
    Reminders...
    1. The pilot phase of Zipline began May 31st, when IRB J began accepting new applications from the Information School, and all requests for review by WIRB now go through Zipline.
    2. On June 15, all other academic units reviewed by IRB J begin using Zipline.
    3. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline.
    4. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
    5. Copies of the webinars and talks given by Karen Moe and the Regulatory Affairs team are available on the Zipline News page and the Zipline General Help page page.
    6. All forms necessary for using Zipline are now linked to the HSD forms page under "Z".
    7. If you need help with Zipline or the new forms, contact the Team Operations Lead associated with the IRB that reviews for your department, or contact hsdinfo@uw.edu.

    News Features

    Using the IRB Protocol Form as a Paper Application

    This news applies only to departments who are NOT using Zipline for new IRB applications. Researchers inWriting these departments may now choose to use the new IRB Protocol form as part of a paper-based IRB application. A supplemental cover sheet (which contains questions from the Zipline SmartForms and places for signatures) must accompany the paper IRB Protocol form.

    This option is being provided by HSD in response to numerous requests from researchers who recognize that using the IRB Protocol form as a paper form now may save them work later when the paper application must be converted to an electronic Zipline application. See the instructions on the Supplement, and the IRB Protocol Form for more details. Contact your HSD Team Operations Lead or hsdinfo@uw.edu if you have any questions.


    Ancillary Review

    NEW! HSD has removed the requirement for Department Ancillary Review. Students, residents, fellows and post-docs still need to obtain Faculty Advisor sign-off through the Ancillary Review process. The article below has been updated to reflect this new policy.

    During the past two months of widespread, detailed communications with campus about Zipline, HSD has learned to expect that every outreach session will include questions about ancillary review. This news item provides key points about the ancillary review process.

    Signature on paper IRB applications = Ancillary Review on electronic Zipline IRB applications

    Ancillary Review is an example of Zipline "jargon" - that is, a term that is used in a particular profession or setting. In this case, ancillary review simply means the process of obtaining review and signatures. Researchers have long been required to provide three types of signatures on a paper-based IRB application:

    • Department (or other academic unit such as a Division or Center)
    • Faculty Advisor (for student researchers)
    • Principal Investigator (PI; also called the Lead Researcher)

    In Zipline, the Department sign-off and the Faculty Advisor sign-off are provided through the process called Ancillary Review. The PI's "signature" is provided by requiring the PI (or PI Proxy) to click on the "SUBMIT" button when an application is electronically sent to HSD.

    Similarities between Ancillary Review and paper signatures

    • Both are required in order to obtain IRB approval; one is required for paper-based IRB applications, the other is required for Zipline (electronic) IRB applications.
    • The meaning/purpose is the same. As described in the SOP Signatures on IRB Forms:
      • The Department sign-off provides documentation of the department's approval of:
        • The PI's qualifications for conducting the proposed research, based on knowledge of the investigator's academic position, education, resources for the research and expertise;
        • The scientific merit of the proposed research (for research that has not received a peer review of merit through an external process, such as by a funding agency).
      • The Faculty Advisor sign-off provides confirmation that the faculty advisor:
        • Accepts responsibility, together with the student investigator, for ensuring that the research is performed in an ethical manner that complies with appropriate human subjects regulations and with the information provided in the application. This may include assisting the IRB or HSD, if they are unable to effectively communicate with the student or if problems develop.
        • Has reviewed and approves of the research, including the purpose, design, methodology, procedures and subjects;
        • Will provide oversight, advice, and guidance during the course of the research.

    Differences between Ancillary Review and paper signatures

     

    Ink Signatures

    Ancillary Review

    Type of IRB application

    Paper-based

    Electronic (Zipline)

    Timing with respect to submission of an IRB application

    Must be obtained before submitting an IRB application

    (A sequential process)

    Must be requested before submitting an IRB application, must be obtained before IRB approval can be granted

    (A concurrent process)

    Impact on timing of IRB submission when a department's primary reviewer is unavailable

    Significant. PI must retrieve paper application and transport it to the primary reviewer's backup

    Minimal. The ancillary request is always sent to all ancillary reviewers, so the absence of a primary reviewer does not slow down the process

    Provides opportunity for comments to the IRB

    No

    Yes

    The process can be used to provide efficient access to, and discussion of, IRB applications by a department group review process (for departments that require IRB applications to undergo a formal department review)

    No

    Yes

     

    Who performs the Ancillary Review for departments

    • It is the Department Chair's responsibility to sign off on applications, or to delegate the responsibility to another individual(s).
    • HSD contacts each department before the date when the department will begin using Zipline, to obtain the name and contact information of the department's ancillary reviewers. HSD has observed that this contact sometimes prompts departments to make changes in who provides department sign-off. In other words, ancillary review may not be conducted by the same person who provided signatures on paper IRB applications.
    • Departments may name as many ancillary reviewers as they wish, but the approval of only one ancillary reviewer is required.

    What is it like to be an Ancillary Reviewer

    The reviewer automatically receives an email notification from Zipline that an Ancillary Review is needed. The email contains a link directly to the application requiring review. The reviewer can open and close the application as many times as needed before deciding whether to sign-off on the application as "Accepted" or "not Accepted". The reviewer can communicate with the PI prior to making the decision.

    All individuals designated as department Ancillary Reviewers will receive the email notifications. It is up to them to establish a system for managing which person will review which IRB application. The Ancillary Reviewers not doing the review may delete the email notification.

    Additional information about Faculty Advisor Ancillary Review

    • In contrast with paper IRB applications, Faculty Advisor sign-off (i.e., Ancillary Review) is required for Zipline IRB applications from fellows, residents, and post-docs, as well as graduate and undergraduate students.
    • Faculty Advisors continue to have access to an IRB application after providing sign-off. They are automatically added to the Guest List. This read-only access continues until the study is closed.
    • A Faculty Advisor cannot be listed as a member of the Study Team in Zipline. (It is not required to list all actual study team members in Zipline; the main purpose of the Zipline Study Team area is to identify individuals who will have read-edit access to the IRB materials.)

    Complete the Online Tutorial on Ancillary Review

    This tutorial titled "Submitting Faculty Advisor Ancillary Review in Zipline" is a great way to become even more familiar with the terms and processes involved in Ancillary Review.


    For the Record Returns

    For the Record, HSD's regular monthly newsletter returns on July 5th. While Zipline is rolling out, For the Record will serve as the main source of communication about policy and process changes, regulatory updates, and non-Zipline news. zNews will continue to be published bi-weekly through the end of August.


    Pardon Our Dust

    Safety Cone
    Pardon our dust during June
     while we finish making all of the Zipline-related changes to the HSD website and ensure consistency of information across web pages and documents.


    Upcoming Important Dates

    Cancer Consortium Informational Sessions

    This is the last of three sessions that will review and discuss important Zipline information about how UW members of the Cancer Consortium obtain HSD authorization to send oncology-related IRB applications to the Cancer Consortium IRB instead of the UW IRB.

    Date Time Location
    Monday, June 27 10:00-11:00am Harborview R&T Bldg., Room 113

    Committee B

    Zipline will be open for new applications from the College of Engineering on September 1st. The remainder of departments that belong to Committee B will be able to enter new applications through Zipline on September 15th.

    A Frequently Asked Question

    Q: Can I set up a default ancillary reviewer?

    A: Yes. You can set up a person as an ancillary reviewer. This person will then be automatically contacted when you "Submit" a new application. In other words, this allows you to skip the step of "Manage Ancillary Reviews" as part of the submission process.

    Q: Where do I do this?

    A: When you log into Zipline, you'll notice that your name appears in the upper right hand corner of the screen. Click on it, and you'll be taken to a screen where you an update your profile information. Use the drop down menu beneath the properties tab and select "Default Ancillary Reviews". Here you can assign a person or organization (department, division, etc.) as your default ancillary reviewer. In general, you should select your academic unit instead of a specific person unless you are a department chair, vice dean, or dean.  If you are a department chair, vice dean, or dean, you should select the person above you in the research academic hierarchy. For example, department chairs should obtain Ancillary review from their Vice Dean for Research. See the Zipline Sneak Peek screen shot below.

     


    Zipline Sneak Peek
    Manage Ancillary Review

    The screen shot above shows the "Manage Ancillary Reviews" activity in the "My Current Actions" menu.

    Default Ancillary Reviewers

    The screen shot above shows the "Default Ancillary Reviewers" activity in your profile.

    See future issues of zNews for more sneak peeks of key screen shots!

     


     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    Ancillary Review

    In Zipline, the ancillary review activity allows individuals and academic units to provide feedback and sign-off on a study in parallel with the IRB review. This replaces the signature requirements associated with paper-based IRB applications. The purpose of the Ancillary Review sign-off is exactly the same as the paper-based signature requirements.

  • zNews - HSD Zipline Rollout - Assigning Roles in Zipline

    Jun 9, 2016 at 10:15am
    Reminders...
      1. The pilot phase of Zipline began May 31st, when IRB J began accepting new applications from the Information School, and all requests for review by WIRB now go through Zipline.
      2. On June 15, all other academic units reviewed by IRB J begin using Zipline.
      3. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline.
      4. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
      5. Copies of the webinars and talks given by Karen Moe and the Regulatory Affairs team are available on the Zipline News page and the Zipline General Help page.
      6. All forms necessary for using Zipline are now linked to the HSD forms page under "Z".
      7. If you need help with Zipline or the new forms, contact the Team Operations Lead associated with the IRB that reviews for your department, or contact hsdinfo@uw.edu.

    News Features
    Roles in Zipline  
    The Most Important Message
    Zipline's flexibility allows the PI or study team members to assign specific roles and abilities to other individuals - such as the ability to view or to edit the applications in Zipline.

    The information presented here is also available in the online tutorial titled: Managing the Study Team in Zipline. The term "application" refers to: initial IRB application; modification; Status Report (Continuing Review); response to Requests for Clarification; and response to reviews.

     
    Principal Investigator (PI)
    Description: The person with overall responsibility for the design and conduct of the research.
    How to assign: Zipline assumes that the person who clicked on Create a Study to begin preparing an initial IRB application is the PI. If this is not correct, the person who is preparing the IRB application can re-assign the role of PI to anyone who is registered in Zipline. This is accomplished while completing (or editing) the first SmartForm ("Basic Information") before it is submitted to the IRB.
    How to change: After the study has received initial approval, the PI can be changed only by submitting a Modification.
    Activities and permissions:
    • Can view and edit the Zipline application
    • Can submit applications or responses
    • Receives all communications and notifications from HSD and the IRB
     
    Study Team Member
    Description: The role of Study Team Member allows the study team to have access to the application. Assigning the role of study team member is optional; however, all study team roles (not names) should be listed on the Study Roles Addendum that is attached to the Zipline SmartForms.
    How to assign: Study team members can be added by any member of the Study Team (including the PI or PI Proxy) at any time using the Manage Study Team activity. This is not considered a modification. However, if the study team roles change (e.g. addition of the role: Licensed Practitioner) a modification must be submitted.
    How to change: Study Team members can be added or removed by any member of the Study Team, at any time, using the Manage Study Team activity. This is not considered a modification, as long as the study team roles do not change.
    Activities and permissions:
    • Can view and edit the Zipline application
    • Cannot submit applications or responses
    • Does not receive all communications and notifications from HSD and the IRB
     
    PI Proxy
    Description: The PI Proxy is a member of the Study Team to whom the PI has given permission to complete activities that are normally restricted to the PI only. Studies are not required to have a PI Proxy. Zipline makes this role available for PI convenience and logistical reasons.
    How to assign: The PI must assign the PI Proxy role to a study team member(s) using the Assign PI Proxy activity. This activity must be completed for each study; Zipline does not allow the PI to assign a default PI Proxy across all their studies.
    How to change: PI Proxies can be changed, added, or removed at any time, but only by the PI. This is accomplished through the Assign PI Proxy activity.
    Activities and permissions:
    • Can view and edit the Zipline application
    • Can submit applications or responses
    • Receives all communications and notifications from HSD and the IRB
    • Can request department sign-off on behalf of the PI, through the Manage Ancillary Review activity
     
    Primary Contact
    Description: The Primary Contact receives all communications and notifications from HSD and the IRB. Studies are not required to have a primary contact in addition to the PI. Zipline makes this role available for PI convenience and logistical reasons.
    How to assign: Zipline assumes that the person who clicked on Create a Study to begin preparing an initial IRB application is the Primary Contact.
    How to change: The Primary Contact can be changed, added, or removed at any time, by any member of the Study Team (including the PI or PI proxy), through the Assign Primary Contact activity. The primary contact may be a member of the Study Team, or it could be someone who is not a Study Team member.
    Activities and permissions:
    • Can view and edit the Zipline application
    • Cannot submit applications or responses
    • Receives all communications and notifications from HSD and the IRB
     
    Guest
    Description: A Study Guest is someone who is not a member of the study team but who needs to be able to view the application in Zipline.
    How to assign: Guests can be added at any time, by any member of the Study Team (including the PI or PI proxy), through the Manage Guest List activity.
    How to change: Guests can be changed or removed at any time, by any member of the Study Team (including the PI or PI proxy), through the Manage Guest List activity.
    Activities and permissions:
    • Can only view applications and responses
    • Cannot edit applications and responses
    • Cannot submit applications or responses
    • Does not receive communications and notifications from HSD and the IRB
      Pardon Our Dust

    Safety Cone Pardon our dust during June while we finish making all of the Zipline-related changes to the HSD website and ensure consistency of information across web pages and documents.


    Upcoming Important Dates
    Cancer Consortium Informational Sessions

    These sessions will review and discuss important Zipline information about how UW members of the Cancer Consortium obtain HSD authorization to send oncology-related IRB applications to the Cancer Consortium IRB instead of the UW IRB.

    Date Time Location
    Tuesday, June 20 1:30-2:30pm Health Sciences T663
    Wednesday, June 22 9:00-10:00am Seattle Cancer Care Alliance, Room G1006/1008
    Monday, June 27 10:00-11:00am Harborview R&T Bldg., Room 113

    A Frequently Asked Question

    Q: Can more than one person be a PI Proxy on a study?

    A: Yes. However, only the PI can assign this role. The assignment is made through the Assign PI Proxy activity.


    Zipline Sneak Peek

    Roles

    The image to the left shows a section of the activity menu in Zipline. Many of the role assignments described above can be made here, depending on the status of your study (e.g., Pre-Submission; IRB Review, etc.).

     

    See future issues of zNews for more sneak peeks of key screen shots!

         
     
    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    Sponsored UW NetID

    UW NetID stands for University of Washington Network Identification. Your NetID and password together allow you to access your UW information and other online services, including Zipline. No one can access Zipline without a UW NetID. All UW faculty, staff, and students establish UW NetIDs when they join the UW community.

    Individuals who are not otherwise eligible for a UW NetID but who have legitimate reasons to access certain UW online services (including Zipline) may be sponsored by a current UW faculty or staff member. Any current UW faculty or staff member can sponsor individuals for a UW NetID using the online self-service Sponsored UW NetID tool. See the UW IT website on sponsored UW NetIDs for more information.

  • zNews - HSD Zipline Rollout - Rollout has Begun!

    Jun 3, 2016 at 2:25pm
    Reminders...
    1. The pilot phase of Zipline began yesterday, May 31st, when IRB J began accepting new applications from the Information School, and all requests for review by WIRB now go through Zipline.
    2. On June 15, all other academic units reviewed by IRB J begin using Zipline.
    3. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline.
    4. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
    5. All forms necessary for using Zipline are now linked to the HSD forms page under "Z".

     

    News Features

    The Information School are the pioneer users of Zipline. HSD appreciates their willingness to go first, their focus on improving ways of managing information, and the value of empowering users with technology. Thank you!

    Getting Started in Zipline

     

    The Most Important Message
    There are a few very basic steps you need to take before registering in Zipline and preparing a new study. Follow the checklist below and watch for your department's personalized Go-Live Readiness Packet.

    This issue of zNews focuses on what to do to start using Zipline. This information is also contained in the generic version of the Go-Live Readiness Packet that is available on the HSD website and the personalized version distributed to each department before they begin using Zipline.

    Before You Begin Preparing an IRB Application

    Check BoxVerify that your computer operating system and Internet browser are compatible with Zipline. See the Supported Operating Systems and Internet Browsers on the Zipline Known Issues page.

    Check BoxRegister in Zipline. This is a one-time requirement that takes only a few minutes. You are REQUIRED to have a UW NetID and password to complete self-registration. This registration creates your user profile. See the INSTRUCTIONS: Registering in Zipline for step-by-step instructions, a screenshot, and what to do if you do not have a UW NetID. Your user profile can be edited at any time after self-registration.

    Check BoxAsk your study team members to register in Zipline. All members of the study team must self-register in Zipline, following the instructions above. Members of the study team will be able to read and edit your IRB application.

     

    When You are Ready to Start Your IRB Application

    Check BoxRead over the new IRB Protocol form and Study Roles Addendum. HSD strongly recommends completing the forms before going into Zipline to create your new application. You will be required to attach the completed IRB Protocol form in order to advance past the first Zipline SmartForm.

    Check BoxRead the self-directed learning materials about Submitting a New Study in Zipline. The Online Tutorial is interactive, takes just 10-15 minutes, and has embedded videos. The Instructions document has several screen shots illustrating the step-by-step instructions.

    Check BoxLearn how to assign a PI Proxy. If you are the Principal Investigator (PI), you may want to make a member of your study team a PI Proxy. Any member of your study team can prepare the IRB application but only you and the PI Proxy can actually submit the completed application to the IRB. The PI Proxy receives all communications from the IRB (as does the PI and the Primary Contact). See the Online Tutorial for Managing the Study Team and Study Access and Instructions: Assign PI Proxy.

    Check BoxLearn how to assign a Primary Contact. The primary contact role is assigned by default to the person who creates a study in Zipline (that is, clicks on the Create New Study button in Zipline). This person receives all communications from the IRB (as does the PI and PI proxy), may edit the application, and may or may not be a member of the study team. If you created the study but want to assign the primary contact role to someone else, see the Instructions: Assign Primary Contact

    Check BoxIf you are the person who will submit the study to HSD: Learn about obtaining department sign-off on your IRB application. Take the Online Tutorial or read the Instructions about Managing Ancillary Reviews.

     

    If You Need Help

    Check BoxBrowse the self-directed learning materials. The Online Tutorials are interactive, short, and have embedded videos. The Instructions documents have several screen shots illustrating the step-by-step instructions.

    Check BoxCall or email the HSD Team Operations Lead associated with the IRB that reviews your studies. See this contact finder if you don't know the person's name or contact information. This is a great way to obtain one on one help. For the departments that begin using Zipline on May 31 or June 15, your Team Operations Lead is Amanda Guyton, aguyton7@uw.edu, 616-5576.

    Check BoxEmail HSD at hsdinfo@uw.edu. This is the main help address for HSD and Zipline, and is the other primary way to obtain one on one assistance from an HSD staff member. It is closely monitored Monday through Friday, 8:00 AM to 5:00 PM.

    Check BoxCall the HSD Front Desk at 206-543-0098. Front desk staff will be able to help with many basic issues, but will also refer you to an appropriate person if your question is technical or regulatory in nature.

     

    Pardon Our Dust

    Safety Cone
    Pardon our dust during June
    while we finish making all of the Zipline-related changes to the HSD website and ensure consistency of information across webpages and documents.


    Upcoming Important Dates

    Cancer Consortium Informational Sessions

    See the table below for oncology researcher information session dates.

    Date Time Location
    Tuesday, June 20 1:30-2:30pm Health Sciences T663
    Wednesday, June 22 9:00-10:00am Seattle Cancer Care Alliance, Room G1006/1008
    Monday, June 27 10:00-11:00am Harborview R&T Bldg., Room 113

     


    A Frequently Asked Question (A Reminder)

    Q: Where can I find the recordings and power points of the presentations that Karen Moe has been giving on campus? 

    A: They have been relocated to the Zipline General Help Page.  They will remain posted for as long as they are relevant. 

     


    Zipline Sneak Peek

    Zipline Home Page

    The image above shows the main Zipline login page. Note:

    • Log in by clicking on the Zipline logo, or just below.
    • The email address to obtain help.
    • The left hand navigation:
      • Education: links to all self-directed learning materials
      • FAQs: a work in progress
      • Known Issues: information about any compatibility issues with operating systems and browsers, also a work in progress
    • The Featured News section where HSD will post news about Zipline down-times, upgrades, and patches.

     

    See future issues of zNews for more sneak peeks of key screen shots!

     


     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    PI Proxy

    The PI Proxy is a specific role that the Principal Investigator (PI) can assign to one or more members of the study team. The PI Proxy must be assigned on each study. The proxy can perform all actions normally restricted to the PI on a study, such as sending applications for department review or submitting an IRB application to HSD. The one exception: the PI proxy cannot submit a request for External IRB review to HSD.

    A proxy receives the same e-mail notifications from the Zipline system as the PI and primary contact person. There can be more than one PI proxy for a study. The PI retains the ability to perform all PI actions and can add or remove the proxy role at any time.

  • zNews - HSD Zipline Rollout - Review of Oncology Research

    May 26, 2016 at 2:07pm
    Reminders...
    1. The pilot phase of Zipline begins May 31st, when IRB J starts accepting new applications from the Information School, and all requests for review by WIRB must go through Zipline.
    2. On June 15, all other academic units reviewed by IRB J begin using Zipline.
    3. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline.
    4. Attend one, or several, of the Zipline Roadshows (see the schedule on our website).
    5. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
    6. All forms necessary for using Zipline are now linked to the Zipline News page and the HSD forms page.

    News Features

    Changes in the Review of UW Oncology Research by UW Members of the Cancer Consortium

     

    The Most Important Message
    Beginning July 1:
    1. Oncology-related studies that involve no subject contact (e.g., medical records reviews with a full consent waiver) will be reviewed by the UW IRB instead of the Cancer Consortium IRB (CC-IRB). Studies obtaining consent from subjects will still go to the CC-IRB via the Clinical Research Support (CRS) offices.
    2. For UW studies still going to the CC-IRB for review, use the new e-IRB system called Zipline to obtain the HSD sign-off.

     

    Change #1: UW oncology studies that involve no subject contact will be reviewed by the UW IRB instead of the Cancer Consortium IRB (CC-IRB) beginning July 1, 2016

    Since 2007, the Cancer Consortium IRB (cc-IRB) at the Fred Hutchinson Cancer Research Center has done an outstanding job at being the IRB of record for hundreds of UW oncology-related studies from UW members of the Cancer Consortium.

    The CC-IRB will continue to review all UW oncology-related studies that involve contact with subjects andChange sign obtaining of consent, when the PI is a member of the Cancer Consortium. This will allow UW oncology trials to continue to benefit from the CC-IRB's oncology expertise and from the Hutch and Cancer Consortium management of the oncology consent form database, coordination with the Scientific Review Committee, and clinical trials registration support.

      • All oncology-related research involving no subject contact (and a waiver of consent) will be reviewed by the UW IRB instead of the CC-IRB, beginning July 1, 2016. Examples: medical records reviews, many specimen studies.
    APPLYING TO THE UW IRB
      • It is a paper-based process until December 15 for most oncology researchers. Beginning May 31, the UW is beginning the transition from a paper-based application system to an e-IRB system called Zipline. As shown in the table below, the departments with most oncology researchers will begin using Zipline for new IRB applications on December 15. Significant outreach and communication will occur within each department during the two months prior to its Zipline implementation.
      • The application forms for the UW paper process are located on the HSD forms page. The most appropriate form will almost always be the APPLICATION: Specimen or Data Use, Identifiable. It is available in either PDF or Word format.
      • The UW assigns applications to IRB committees based on the PI's department. Each IRB is supported by a team of HSD staff. Contact the Team Lead of your IRB if you have any questions about which form to use, how to answer questions, or the UW IRB review process. Check this list to find out which IRB and HSD Team will receive your application if your department is not listed in the table below.

     

    UW Department UW IRB Begin Using Zipline for New Applications HSD Team Operations Lead
    Medical Oncology

    Pathology
    IRB A Dec 15 Laurie Berger
    lberger@uw.edu
    206.543.3033
    Radiation Oncology

    Radiology
    IRB D Dec 15 Leah Miller
    lemiller@uw.edu
    206.543.2977

     

    Change #2: Use the new e-IRB system called Zipline to obtain the HSD sign-off for Change scrabblesending UW oncology studies to the Cancer Consortium IRB for review. Provide the sign-off to Clinical Research Support (CRS) with your other study materials.


    The purpose of this sign-off process is to authorize the review of UW research by another IRB. The table below summarizes the current and new review authorization processes.

     

    Current Authorization Process New Authorization Process
    1. Researcher prepares the Review Authorization UW/CC IRB form.
    2. Researcher submits the form (with other study materials) to Clinical Research Support (CRS).
    3. CRS submits the Review Authorization form to HSD on behalf of the researcher. CRS also routes a copy of the IRB application for wet ink division signature.
    4. HSD signs the Review Authorization form and emails it back to CRS.
    5. CR submits the completed review authorization along with the other study materials to the Cancer Consortium IRB.
    1. Researcher prepares the new form called Review Authorization: External IRB.
    2. Researcher requests External IRB review through Zipline. This requires the completion of some simple web-based SmartForms and the attachment of:
      • The REVIEW AUTHORIZATION: External IRB form
      • A description of the research (such as the study protocol)
      • Other relevant documents (described on the Review Authorization form)
    3. HSD authorizes the use of the Cancer Consortium IRB and uploads a signed copy of the Review Authorization form Zipline for the researcher.
    4. Researcher provides the signed Review Authorization form to Clinical Research Support (CRS) with other study materials for the CC-IRB review.
    5. The Zipline feature that allows electronic division sign-off (instead of an ink signature on paper) will not be available until sometime this fall for studies reviewed by a non-UW IRB.

      Study teams should request department/division sign-off via email and submit this email to CRS with their IRB application and approved HSD authorization. This email acknowledgement will be in place of a "wet ink" signature.

     

    Instructions and learning materials are available now on the HSD website:

    These changes apply to all  UW oncology researchers  who are members of the Cancer Consortium in all UW departments, beginning July 1st.
    For more information, contact hsdrely@uw.edu or attend one of these informational sessions:
    Date Time Location
    Monday, June 20 1:30-2:30pm Health Sciences T663
    Wednesday, June 22 9:00-10:00am Seattle Cancer Care Alliance, Room G1006/1008
    Monday, June 27 10:00-11:00am Harborview R&T Bldg, Room 113

    Upcoming Important Dates

    Zipline Roadshows

    The information and training opportunities for campus are being kicked off with a traveling "roadshow" around campus. It consists of a series of four 1-hour presentations.

    • Each presentation is independent of the others. Attend one, all, or any number of them and in any order.
    • Each presentation will be offered three times, with a webinar from the Tower Auditorium for remote attendance and for recording. The recorded webinar will be available on HSD's website.
    • Each session will consist of a 35-minute presentation plus 25 minutes for questions.

    See the full schedule plus links to the webinars on our website.

    Cancer Consortium Informational Sessions

    See the table below for oncology researcher information session dates.

    Date Time Location
    Tuesday, June 20 1:30-2:30pm Health Sciences T663
    Wednesday, June 22 9:00-10:00am Seattle Cancer Care Alliance, Room G1006/1008
    Monday, June 27 10:00-11:00am Harborview R&T Bldg., Room 113

     


    A Frequently Asked Question

    Q: Where can I find the recordings of the presentations that Karen Moe has been giving on campus? 

    A: They have been relocated to the Zipline General Help Page.  They will remain posted for as long as they are relevant. 

     


    Zipline Sneak Peek

    The image below shows the external IRB question on the Zipline Basic Information Smartform. You should select YES when your study needs to be reviewed by the Cancer Consortium IRB instead of the UW IRB. The SmartForm will then “branch” to a few additional questions.


    External IRB Basic Page Question

    The image below shows you the first two questions about the external IRB that are revealed when you select "Yes" from the basic information page. The second question is where you upload your completed Review Authorization form.

    External IRB Page

    See future issues of zNews for more sneak peeks of key screen shots!

     


     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    Review Authorization

    This term refers to the process by which HSD authorizes your study to be reviewed by a non-UW IRB (also called an external IRB) instead of the UW IRB. Currently, there are different review authorization processes for different external IRBs – for example, one process for WIRB, another process for the Cancer Consortium IRB, and yet another process for review by an IRB at a different academic institution. With Zipline, HSD is gradually implementing a single standard authorization process for all studies and all external IRBs. The implementation of this new process begins on May 31 for all studies going to WIRB. The next step is to include CC-IRB reviews, beginning July 1.

  • zNews - HSD Zipline Rollout - Conversion from Paper to Electronic

    May 13, 2016 at 1:57pm
    Reminders...
    1. The pilot phase of Zipline begins May 31st, when IRB J starts accepting new applications from the Information School.
    2. On June 15, all other academic units reviewed by IRB J begin using Zipline.
    3. Zipline requires the use of a new APPLICATION: IRB Protocol that is uploaded to Zipline.
    4. Attend one, or several, of the Zipline Roadshows (see the schedule on our website). The next roadshow is tomorrow, Thursday, May 12th at 11 am in Health Science's Foege Auditorium.
    5. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
    6. NEW All forms necessary for using Zipline are now linked to the Zipline News page.

    News Features

    Conversion of Existing Paper-Based IRB Applications

     

    The Most Important Message
    Researchers will need to convert many existing paper-based IRB applications into a Zipline application in the next year or two.

     

    One of the toughest issues in converting any paper-based process to an electronic process is what to do with Paperless Officethe existing paper-based items. Should paper-based IRB applications stay on paper for the duration of the study? Or, should all paper-based applications be re-created ("converted") in the electronic system? The reasons to require conversion are: (1) many existing studies will continue to exist for years, even decades; (2) maintaining dual systems (paper, Zipline) at the same time is confusing and inefficient for researchers and the IRBs; and (3) the advantages of Zipline are compelling even for ongoing studies.

    HSD is taking a hybrid approach in order to balance the relative advantages and disadvantages of conversion for different types of IRB applications. Conversion will be required for about half of the currently open IRB applications; the remaining applications can stay in their paper format.


    All currently approved studies reviewed by the UW IRB must be converted EXCEPT:
    • Exempt studies.
    • Studies closing within one year after the current approval expiration date.
    • Studies previously authorized by HSD for review by WIRB or the Fred Hutchinson IRB.
    Conversion will be required at the time of a study's Status Report, for studies that expire about two months or more after a researcher's academic unit starts using Zipline.

    Example: Studies reviewed by IRB Committee J that expire on or after September 1 must create a "conversion application" as part of the Status Report. See the table below for the specific dates.

    Phase

    Zipline Roll-out and Conversion Dates

     

    1

    Academic Units reviewed by IRB J

    • May 31 - New applications from the Information School
    • June 15 - New applications from all academic units reviewed by IRB J
    • Sept 1 - Conversion date

    Studies expiring on or after this date must create a "conversion" application as part of the Status Report. Applies to all academic units reviewed by IRB J

     

    2

    Academic Units reviewed by IRB B

    • Sept 1 - New applications from the College of Engineering
    • Sept 15 - New applications from all academic units reviewed by IRB B
    • Nov 15 - Conversion date

    Studies expiring on or after this date must create a "conversion" application as part of the Status Report. Applies to all academic units reviewed by IRB B

     

    3

    Academic Units reviewed by IRB G

    • Oct 15 - New applications from the College of Education
    • Nov 1 - New applications from all academic units reviewed by IRB G
    • Jan 1 - Conversion date

    Studies expiring on or after this date must create a "conversion" application as part of the Status Report. Applies to all academic units reviewed by IRB G

     

    4

    Academic Units reviewed by IRB A and D

    • Dec 1 - New applications from the School of Nursing and the Department of Family Medicine
    • Dec 15 - New applications from all academic units reviewed by IRB A and D
    • Feb 15 - Conversion date

    Studies expiring on or after this date must create a "conversion" application as part of the Status Report. Applies to all academic units reviewed by IRB A and D

     

    For each study that must be converted, HSD will send an email notice to the researcher and study contact person at 16 weeks, 10 weeks, and six weeks before the study's expiration date.

    This is this official notification that a study must be converted into a Zipline application and the deadline for doing so. The 16 week advance notice will provide researchers with time to plan for the work of Data Analysis Only Status. Conversion will be relatively easy for studies whose current and future procedures consist solely of the study's IRB-approved data analyses. You must complete the Zipline SmartForms and attach the APPLICATION: Status Report, Conversion Study. However, no other documents are required. For example: no IRB Protocol form and no study consent form.conversion. HSD strongly recommends submitting the conversion application at least six weeks before the expiration date, because conversion applications will take longer to review than an ordinary Status Report.

    Researchers whose circumstances may make conversion especially challenging (for example, having three studies that all require conversion within the same month) should contact the HSD Team Operations Lead for their IRB Committee about possible special arrangements.

    A conversion application is essentially the same as submitting a new application in Zipline except that it should describe only the current and future activities of the study.

    HSD has done everything possible to limit the information required in a conversion application and make the process easier for researchers. For example:

    • Grant applications do not need to be provided again, if they were already provided on paper.
    • Existing Confidentiality Agreements do not need to be provided.
    • Recruiting materials do not need to be provided if all recruiting activities have been completed.
    • Specific instructions about what is, and is not, required are located on the Zipline Conversion webpage. Additional details will be provided on that page during the coming month.
    There are many reasons why current paper applications cannot be scanned and uploaded to Zipline. For example:
    • The modification process in Zipline involves making tracked changes to the SmartForms and Word documents. "Tracked changes" is not possible with scanned PDF documents.
    • The inadequacies of our current paper forms means that much of the important information in existing paper IRB applications is contained in the "back and forth" correspondence between the IRB and researchers. This has resulted in significant delays of reviews as well as overlooked issues. It is important for efficiency and compliance reasons to not perpetuate this problem by scanning the correspondence.
    • The logistics of scanning files that are many inches (or even feet) thick, contain an unpredictable mix of single-sided and double-sided pages, and countless staples, paper clips, and binder clips scattered throughout the file make scanning impractical.
    There are three optional things researchers can do to make their future conversions easier. Details will be available by May 31 on the HSD Zipline webpage.
    1. Use the Conversion Worksheet and Tracker tool that HSD created for the "Go Live Readiness Packet". It is designed to help you identify which studies you need to convert, and when.Data Charts and Graphs
    2. Assess your IRB application for procedures and documents related to your current and future study activities versus already-completed activities. Use some method of labeling them.
    3. NEW Use the new IRB Protocol form as a paper application form, following the special instructions for this new option. Many researchers will continue to submit paper IRB applications during the next seven months because Zipline will not have been implemented yet in their departments. This means they will be creating paper applications that will have to be converted to a Zipline application a year later. In response
      to recent campus requests, HSD has decided to allow researchers who will not be able to use Zipline until later in the year to choose whether to continue to use the existing paper forms or to use a paper (printed) copy of the new IRB Protocol prior to their use of Zipline. The advantage: future conversion work will be significantly reduced, because the most-time consuming part of creating a conversion application (completing the IRB Protocol form for Zipline) will have already been completed. The disadvantage: learning a new form that is significantly different from HSD's current paper forms.
    4. This is not a requirement. It is intended to provide researchers with some additional flexibility and control regarding the transition to Zipline. It is an option that has been requested by some researchers because it avoids some later conversion work or because they prefer the new IRB Protocol form.

    Conversions will be the most challenging part of the transition to Zipline. They will require significant time and work from researchers and HSD staff. HSD is providing detailed instructions, expectations, and support.

    See the special Zipline Conversions webpage on the HSD website.


    Upcoming Important Dates

    Zipline Roadshows

    The information and training opportunities for campus are being kicked off with a traveling "roadshow" around campus. It consists of a series of four 1-hour presentations.

    • Each presentation is independent of the others. Attend one, all, or any number of them and in any order.
    • Each presentation will be offered three times, with a webinar from the Tower Auditorium for remote attendance and for recording. The recorded webinar will be available on HSD's website.
    • Each session will consist of a 35-minute presentation plus 25 minutes for questions.

    See the full schedule plus links to the webinars on our website.

    WIRB Informational Sessions

    See the table below for WIRB information session dates.

    Date Time Location
    Tuesday, May 17 9:30-10:30am Health Sciences T663
    Monday, May 23 9:30-10:30am Harborview R&T Bldg., Room 113
    Tuesday, May 24 9:00-10:00am Seattle Cancer Care Alliance, Room G1006/1008

     


    A Frequently Asked Question

    Q: Why can't HSD hire staff to do the conversions for researchers?

    A: The new IRB Protocol form asks for information that is not contained in current paper forms. Only researchers and their staff will know the answers to these questions, including which study activities have been completed and which are still pending or in progress.

     


    Zipline Sneak Peek

    Zipline first question

    This is a screenshot of the very first question you will see in Zipline each time you Create a New Study, including the creation of a conversion application. The answer to this question informs HSD staff whether you are submitting a new application versus a conversion application. The "old study number" refers to the five digit IRB number assigned to your paper application. For example: 41577. This number is essential for allowing HSD to link your conversion application to your existing study.

    See future issues of zNews for more sneak peeks of key screen shots!

     


     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    Conversion

    This is the process of turning your current paper IRB application into a Zipline IRB application that describes the current and future activities of your study.

  • zNews - HSD Zipline Rollout - WIRB Process Changes

    Apr 27, 2016 at 1:45pm
    Reminders
  • The pilot phase of Zipline begins May 31st, when IRB J starts accepting new applications from the Information School.
  • On June 15, all other academic units reviewed by IRB J begin using Zipline.
  • Zipline requires the use of a new IRB Application Form that is uploaded to Zipline.
  • Attend one, or several, of the Zipline Roadshows (see the schedule on our website).
  • Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page.
  • All forms necessary for using Zipline will be available on the Zipline News page the week of May 2-6.
  •  

    News Features

    Updated WIRB Process

    The WIRB process will become easier and faster, beginning May 31st.

    The improvements are possible because of Zipline and a policy change. The specific changes include:

    HSD will no longer review consent forms as part of the process.
    • This change will shorten the HSD review authorization process for most studies.
    • WIRB will continue to be responsible for ensuring that all required elements of consent are included.
    • The study team and the sponsor will continue to be responsible for ensuring that:
      • The consent form, clinical trial agreement (contract), and billing plan are consistent;
      • Any consent language stating that the industry company will pay for treatment of research adverse events if the subjects' health insurance will not pay includes a "carve out" that makes it clear that federal healthcare systems such as Medicare will not be billed.
    • HSD will conduct a 100% audit of all consent forms for the issues described above, after WIRB grants IRB approval. The study team and the sponsor will be required to submit (and pay for) a modification request to WIRB to revise any inappropriate consent forms. HSD's experience suggests that this will not be a common occurrence.
    • WIRB is a large independent IRB. The UW relies on WIRB for the review of most industry-sponsored studies. The current process for requesting WIRB review is to email a completed UW/WIRB Request Authorization form and study consent form to HSD. HSD evaluates some of the content of the consent form, and determines whether the study meets the criteria for going to WIRB instead of the UW IRB.
    The request process will now occur in Zipline.

    This change applies to all investigators in all departments beginning May 31st.

    The Zipline process will replace the current email-based process. Zipline will be a single, permanent place where all of the records and correspondence related to the authorization process are stored. It will be accessible by the investigator and study team. See the Frequently Asked Question below for a short description of the new process.

    The UW/WIRB Request Authorization form has been revised.

    Some questions have been removed (because they are located in the Zipline SmartForms), and the form has been re-formatted for easier completion. It will have a new name: the Review Authorization form. It will be available on the HSD website the week of May 2-6.

    A few new questions have been added.

    These are located in the Zipline SmartForms. For example, there are new questions about funding, and whether the study is considered to be a clinical trial. These questions will assist HSD in ensuring that all regulations and requirements applying to the study are identified.

    Department sign-off on the authorization request will be required.

    This new step addresses the regulatory requirement for HSD to receive assurance that the faculty member is considered qualified and able to conduct the research. The sign-off is an electronic process that is initiated by the person preparing the Zipline request, by clicking on a single Zipline button.

    These changes apply to all researchers in all UW departments, beginning May 31st.
    For more information, contact hsdrely@uw.edu or attend one of these informational sessions:
    Date Time Location
    Tuesday, May 17 9:30-10:30am Health Sciences T663
    Monday, May 23 9:30-10:30am Harborview R&T Bldg., Room 113
    Tuesday, May 24 9:00-10:00am Seattle Cancer Care Alliance, Room G1006/1008

     

    Upcoming Important Dates

    Zipline Roadshows

    The information and training opportunities for campus are being kicked off with a traveling "roadshow" around campus. It consists of a series of four 1-hour presentations.

    • Each presentation is independent of the others. Attend one, all, or any number of them and in any order.
    • Each presentation will be offered three times, with a webinar from the Tower Auditorium for remote attendance and for recording. The recorded webinar will be available on HSD's website.
    • Each session will consist of a 35-minute presentation plus 25 minutes for questions.

    See the full schedule plus links to the webinars on our website.

    WIRB Informational Sessions

    See the dates above for more information about the WIRB process changes.

     

    A Frequently Asked Question

    Q: How do I ask HSD to allow my industry-sponsored study to be reviewed by WIRB?

    A: On May 31st, the current email process and form will be replaced by an easy Zipline process:

    1. Complete the new Review Authorization form.
    2. Click on Create a New Study in Zipline. At the bottom of the first SmartForm ("Basic Information"), click YES to the question about an external IRB.
    3. Attach your completed Review Authorization form.
    4. Complete the remaining SmartForms.
    5. Request department sign-off by clicking on Manage Ancillary Review.
    6. Click on Submit. HSD will review your request and provide you with the final outcome and any documents you need. These instructions are included on the new Review Authorization form.

     

    Zipline Sneak Peek

    External IRB Basic Page Question

    The image above shows the external IRB question on the Basic Information SmartForm page of Zipline. The image below shows you the first two questions about the external IRB should you select "yes" from the basic information page. The second question is where you upload your completed Review Authorization form.

    External IRB Page

    See future issues of zNews for more sneak peeks of key screen shots!

     


     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    External IRB

    Beginning May 31st, HSD will use this term to refer to a non-UW IRB that is reviewing UW research on behalf of the UW IRB. In other words, this means the UW IRB is relying upon an external IRB to do the review instead of doing the review itself. Common examples:

    • WIRB: The UW relies upon WIRB to review most UW industry-sponsored clinical trials.
    • Fred Hutch IRB: The UW relies upon the Fred Hutch IRB to review most UW cancer-related research.
    • IRBs at other academic institutions: The UW will often rely upon the IRB at another institution, if a UW faculty member is doing collaborative research and most of the interactions with human subjects will occur at the other institution.
  • Roadshows - Spring 2016 - Zipline!

    Apr 18, 2016 at 5:04pm

    REMINDER - Zipline Roadshows

    The information and training opportunities for campus are being kicked off with a traveling "roadshow" around campus. It consists of a series of four 1-hour presentations.

    • Each presentation is independent of the others. Attend one, all, or any number of them and in any order.
    • Each presentation will be offered three times, with a webinar from the Tower Auditorium for remote attendance and for recording. The recorded webinar will also be available on HSD's website.
    • Each session will consist of a 35-minute presentation plus 25 minutes for questions.
    The Zipline Roadshow
    The Presentations
    Date / Time
    Location
    A Overview Apr 20, Noon-1pm Harborview R & T Auditorium
    Apr 26, 1:30-2:30pm Tower Auditorium (use this link to attend the webinar)
    May 12, 11am-Noon Health Sciences: Foege Auditorium
    B IRB Protocol Form Apr 28, Noon-1pm Harborview R & T Auditorium
    May 10, 12:30-1:30pm Tower Auditorium (use this link to attend the webinar)
    May 19, 11-Noon Health Sciences: Foege Auditorium
    C Zipline: Policy & Process Changes May 18, Noon-1pm Harborview R & T Auditorium
    May 16, 12:30-1:30pm Tower Auditorium (use this link to attend the webinar)
    May 26, 11-Noon Health Sciences: Foege Auditorium
    D Conversion of Existing Paper-based Applications May 25, Noon-1pm Harborview R & T Auditorium
    May 23,12:30-1:30pm Tower Auditorium (use this link to attend the webinar)
    June 2, 11-Noon Health Sciences: Foege Auditorium
  • zNews - HSD Zipline Rollout - The IRB Protocol

    Apr 13, 2016 at 9:54am
    Reminders...
    1. The pilot phase of Zipline begins May 31st, when IRB J starts accepting new applications from the Information School.
    2. On June 15, all other academic units reviewed by IRB J begin using Zipline.
    3. Zipline requires the use of a new IRB Application Form that is uploaded to Zipline. See details below.
    4. Attend one, or several, of the Zipline Roadshows (see schedule, below).
    5. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page

    IRB Protocol

    The IRB Protocol Form is one of the biggest changes associated with the Zipline eIRB system. It is the all-new IRB application form that researchers will upload to the Zipline web-based SmartForms, together with their other study documents. This one form replaces the current six different types of initial application forms.

    Three Parts of an IRB Application in Zipline
    1
    Zipline SmartForms
    2
    IRB Protocol Form
    3
    Other study documents
    (consent form, survey, etc.)

     

    What is the IRB Protocol form like?

    A change in philosophy

    Researchers will no longer need to make regulatory decisions when preparing an IRB application. Instead, the responsibility for those decisions has been shifted to the more appropriate shoulders of HSD staff and the IRBs. For example, researchers currently need to understand and apply the concepts of "minimal risk" and "exempt" status when they:

      • Select which application form to use
      • Answer the questions on many of the Supplements (e.g., Vulnerable Populations, Waiver of Consent)

    One form instead of six

    The same form can be used for all types of reviews, eliminating the need for a decision. However, the form does come in two versions, based on a simple methodological issue: will you have any contact with your human subjects? Use the Standard version of the form when your research will involve contact with subjects. Use the No Contact version if you will be working only with data or specimens (i.e., no subject contact); these questions are a subset of the questions on the Standard version. Highly specialized information is still captured through Supplements, but the Supplements have been revised too - frequently used Supplements have been folded into the IRB Protocol form, and a few new Supplements have been created to address new (but uncommon) regulatory issues.

    When can I access the new form? All the forms needed to prepare an initial application in Zipline will be available on the HSD's forms webpage around May 1st, a full month before the first academic unit begins using Zipline. Watch for the announcement in the zNews

    Different questions

    Some questions have been retained from our current forms, but most of the questions are new or completely re-written.

      • Eliminated: Questions not relevant to the criteria for IRB approval and regulatory determinations
      • Eliminated: Questions that are part of the Zipline web-based SmartForms
      • Combined: Questions from Supplements that were submitted with almost every application have been folded into the form.
      • Added: Questions about issues that were a frequent source of "back and forth" communication between researchers and HSD
      • Added: Questions relevant to recent or clarified regulatory requirements, including some new Supplements (for example, a Supplement about Participant Result Sharing)
      • Changed: Questions that were frequently mis-understood or answered incorrectly
      • Changed: Questions related to policy changes that are being implemented on May 31 (see future issues of the zNews)

    For example, researchers will be able to describe their data security protections by selecting a set of protections from several options described in a Data Security Protections document, instead of speculating about what to describe as appropriate and acceptable to the IRB.

    Citing other documents

    Questions can be answered by citing specific sections of other uploaded documents, instead of re-writing or copy-and-pasting. For example, the lengthy inclusion/exclusion criteria for a clinical trial could be described by saying something like, "See Table 3 on page 7 of the attached grant application."

    Why isn't it a smart form? We love our current “smart” PDF forms, and we are sad that we will not be able to use them in Zipline. But there is a very good reason:  Using Word-based forms is what allows the Zipline system to eliminate the need for separate Modification forms and processes. Instead, to modify a study, you simply make tracked changes on your initial application form (and any other relevant documents) and upload it again to Zipline. When the IRB approves your Modification, the tracked changes are automatically accepted and the revised application form becomes the visible snapshot of your current study. This will make study oversight easier  for researchers and for the IRB. It should also increase the efficiency of Modification reviews. width=

    Revised sequence of topics

    The order of the sections and topics is different. The sequence of questions is designed to have a better flow, to better fit how researchers think about their studies.

    Significant guidance

    One of the most common questions HSD receives is, "How should I answer this question? What does the IRB want to know?" Almost every question on the new form has significant annotation (guidance, definitions, detailed instructions). While this increases the length of the form, it should make the form easier to complete and make the form more likely to provide the information the IRB needs. This extra help is especially important during the transition period when researchers need to "unlearn" the old forms. An unannotated version will be available after all academic units have started using the new form and have developed some experience with it.

    Visual appearance

    Visual design principles have been used to minimize the sense of visual busyness and clutter, and to clearly distinguish questions from guidance/instructions and from answers.

     

    How will the new form help researchers?
    • It eliminates the possibility that researchers will select the wrong form to complete, which causes delay and frustration for everyone involved.
    • It reduces the uncertainty about what information is needed by the IRB.
    • It should result in less "back and forth"; that is, shorter and/or fewer letters and questions from the IRB.
    • It should be easier to follow and complete (once the old forms are "unlearned").
    • It is much more flexible and adaptable to the incredibly diverse types of research conducted at the UW.

    Upcoming Important Dates

    Zipline Roadshows

    The information and training opportunities for campus are being kicked off with a traveling "roadshow" around campus. It consists of a series of four 1-hour presentations.

    • Each presentation is independent of the others. Attend one, all, or any number of them and in any order.
    • Each presentation will be offered three times, with a webinar from the Tower Auditorium for remote attendance and for recording. The recorded webinar will be available on HSD's website.
    • Each session will consist of a 35-minute presentation plus 25 minutes for questions.
    The Zipline Roadshow
    The Presentations
    Date / Time
    Location
    A Overview Apr 20, Noon-1pm Harborview R & T Auditorium
    Apr 26, 1:30-2:30pm Tower Auditorium (also a webinar)
    May 12, 11am-Noon Health Sciences: Foege Auditorium
    B IRB Protocol Form Apr 28, Noon-1pm Harborview R & T Auditorium
    May 10, 12:30-1:30pm Tower Auditorium (also a webinar)
    May 19, 11-Noon Health Sciences: Foege Auditorium
    C Zipline: Policy & Process Changes May 18, Noon-1pm Harborview R & T Auditorium
    May 16, 12:30-1:30pm Tower Auditorium (also a webinar)
    May 26, 11-Noon Health Sciences: Foege Auditorium
    D Conversion of Existing Paper-based Applications May 25, Noon-1pm Harborview R & T Auditorium
    May 23,12:30-1:30pm Tower Auditorium (also a webinar)
    June 2, 11-Noon Health Sciences: Foege Auditorium

    A Frequently Asked Question

    Q: Why is the new IRB Protocol so long?

    A: Though the IRB Protocol form itself is longer than the current IRB Application ("13-11"), it doesn't require several frequently used Supplements. The result: Fewer pages in total, even with extensive annotation.

     

    Form Current New
    Annotated Form 23 32
    Frequently used supplements:    
    Consent Waiver 8  
    HIPAA Waiver 4  
    Genetics 7  
    Vulnerable populations 8  
    Total Pages 50 32

     

    Zipline Sneak Peek
    IRB Protocol Sample

    The image above shows a sample question from the new IRB Protocol form, showing the new font, visual layout, and guidance. The image below shows a section of the Basic Information SmartForm in Zipline.  The IRB Protocol is uploaded at the end of the form.

    Uploading the IRB Protocol

    See future issues of zNews for more sneak peeks of key screen shots!

  • zNews - HSD Zipline Rollout - When?

    Mar 30, 2016 at 10:12am
    Reminders...
    1. The pilot phase of Zipline begins May 31st
    2. One IRB team, and one school will start
    3. A new IRB Application Form that is uploaded to Zipline is part of the change
    4. Past issues of this newsletter are posted to the announcements tab on the HSD home page, as well as the Zipline News page

    News Features
    Announcing the Rollout Schedule!

    The use of Zipline for new applications will be implemented in four phases. Each phase will:

    • Involve all of the departments/academic units reviewed by a specific IRB Committee and HSD staff team.
    • Be restricted for the first two weeks of rollout to new applications from just one of the academic units.
    • See this webpage for a complete list of all academic units and the date when they should start using Zipline. While HSD expects to adhere to this schedule, the experiences of our first IRB and academic units may lead to a minor acceleration or extension of the dates.
    Phase IRB / HSD Teams
    1 IRB / Team J
    • May 31, Information School
    • June 15, all other academic units reviewed by IRB J
    2 IRB / Team B
    • Sept 1, College of Engineering
    • Sept 15, all other academic units reviewed by IRB B
    3 IRB / Team G
    • Oct 15, College of Education
    • Nov 1, all other academic units reviewed by IRB G
    4 IRBs / Teams A and D
    • Dec 1, Family Medicine and School of Nursing (main campus)
    • Dec 15, all other academic units reviewed by IRBs A and D

    Upcoming Important Dates
    Zipline Roadshows

    The information and training opportunities for campus are being kicked off with a traveling "roadshow" around campus. It consists of a series of four 1-hour presentations.

    • Each presentation is independent of the others. Attend one, all, or any number of them and in any order.
    • Each presentation will be offered three times, with a webinar from the Tower Auditorium for remote attendance and for recording. The recorded webinar will be available on HSD's website.
    • Each session will consist of a 35-minute presentation plus 25 minutes for questions.
    The Zipline Roadshow
    The Presentations
    Date / Time
    Location
    A Overview Apr 20, Noon-1pm Harborview R & T Auditorium
    Apr 26, 1:30-2:30pm Tower Auditorium (also a webinar)
    May 12, 11am-Noon Health Sciences: Foege Auditorium
    B IRB Protocol Form Apr 28, Noon-1pm Harborview R & T Auditorium
    May 10, 12:30-1:30pm Tower Auditorium (also a webinar)
    May 19, 11-Noon Health Sciences: Foege Auditorium
    C Zipline: Policy & Process Changes May 18, Noon-1pm Harborview R & T Auditorium
    May 16, 12:30-1:30pm Tower Auditorium (also a webinar)
    May 26, 11-Noon Health Sciences: Foege Auditorium
    D Conversion of Existing Paper-based Applications May 25, Noon-1pm Harborview R & T Auditorium
    May 23,12:30-1:30pm Tower Auditorium (also a webinar)
    June 2, 11-Noon Health Sciences: Foege Auditorium

    A Frequently Asked Question

    Q: How will I log into Zipline?

    A: You will log in using your UW NetID and password. If you don't have a UW NetID, and you are a member of the UW community, you can request one from UW IT. If you are not a member of the UW community, and need a sponsored UW NetID send an email request to hsdinfo@uw.edu.


    Zipline Sneak Peek

    When Zipline is rolled out to a department or other academic unit, it means that researchers in that unit must use the Zipline system and new IRB Protocol Form for all new applications

    Zipline inbox

    This screenshot shows the personalized Zipline inbox when you first log in using your UW NetID.

    • Your list of current actions contains a button to create a new study.
    • The My Inbox link in the header will take you back to your inbox from wherever you are in the system.
    • Your inbox will contain all the items you are working on, or need to take action on.

    See future issues of zNews for more sneak peeks of key Zipline screen shots!

     


    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    Rollout

    This word refers to the implementation plan for Zipline. Specifically, it means when Zipline is made available and to which academic units for ball which types of IRB activities.

    We like "rollout" because it suggests smooth, progressive, movement forward like a ball rolling along the ground toward its goal. The Zipline rollout plan involves a progression of gradually increasing the number of academic units using Zipline. When each unit starts using it, researchers in the unit will use it first for initial applications. Then a few months later, those researchers will start bringing most of their existing paper-based applications into Zipline.

  • zNews - HSD Zipline Rollout- Get Ready!

    Mar 17, 2016 at 12:36pm
    Introducing zNews, the Zipline rollout newsletter from HSD

    Welcome to the new HSD newsletter! It is focused on the rollout of Zipline, the new electronic IRB system that begins a phased implementation on May 31st. You are receiving this newsletter because you've submitted an IRB application to HSD in the past, or you've asked to receive our regular monthly newsletter.

    zNews is intended to be a major source of information about Zipline -  including rollout timelines for specific departments, information about what researchers will need to do, training and instruction opportunities, and Zipline-related procedural changes to the IRB application process. A new issue will be distributed every other week, from now through the end of summer. We hope that you stick around for the news, sneak peeks of the Zipline interface, and bi-weekly drawings for prizes!

    This first issue provides an overview of four key points about Zipline. Subsequent issues will provide more details about each, plus additional news and information.

     

    News Features

     

    Key Point #1: A Phased Rollout

    The use of Zipline for new applications will be implemented in four phases. The dates of each phase will be announced in the March 30th issue of zNews. Each phase will:

    • Involve all of the departments reviewed by a specific IRB Committee and HSD staff team.
    • Be restricted for the first two weeks of rollout to new applications from just one of the departments.

     

    Key Point #2: A Document Management System, not "Turbo Tax"

    When people hear that an electronic IRB system is being implemented, they often think of something like "Turbo Tax" - an electronic form that replaces the basic IRB application. Zipline is not a "Turbo Tax"- type application system. Instead, like most electronic IRB systems, it uses a combination of web forms (SmartForms) plus an IRB application form that is uploaded to the web system. Other standard human subjects documents such as consent forms, questionnaires, and grant applications also still need to be provided through uploading.

    However, none of the documents are printed, provided on paper, or stored on paper. All information is provided to the IRB in digital form, as uploaded electronic documents or as answers on SmartForms. Researchers who are familiar with information management methods will recognize this as a "document management" system.

    One advantage of this specific document management system: It doesn't require a Modification form. To propose changes to your study, you simply (1) upload a "tracked changes" version of the appropriate documents (for example, your initial application form, or your consent form); and/or (2) change the information in the Zipline SmartForms. The system preserves the historical versions of the documents, while displaying only the currently-approved "snapshot" of your study.

     

    Key Point #3: A Completely New IRB Application Form

    A completely new IRB application form will replace the current five different forms: one version for studies involving no interaction with subjects, and another version for all other studies. No regulatory knowledge will be required when deciding which form to use. Each form will be available with or without substantial annotation (i.e., help text and detailed instructions). Experienced "power" users should soon be able to use the shorter, lightly annotated version.

    The new form is long! This is because:

    • Almost every question has significant annotation.
    • Supplement forms and waiver request forms that were used by a majority of researchers have been incorporated into the new form.
    • New questions have been added, based on analysis of issues frequently raised in "back and forth" between researchers and the IRB. The goal is to shorten or eliminate the back and forth, thereby speeding up the review process.

    HSD will provide more information about the new form in the next zNews. Also watch for: future issues of this newsletter; large audience presentations in various campus locations; short online tutorials; and presentations to specific large departments as they approach their Zipline implementation date. And, as always, HSD staff and hsdinfo@uw.edu will be available to help.

     

    Key Point #4: Converting Existing Paper-Based Applications

    One of the thorniest issues in converting any paper-based process to an electronic process is what to do with theConversion from paper to electronic existing paper-based items. Should paper-based studies stay on paper for the duration of the study? Or, should all paper-based studies be re-created ("converted") in the electronic system?

    HSD is taking a hybrid approach in order to balance the relative advantages and disadvantages of conversion for different types of studies. The reasons to require conversion are: (1) many existing studies will continue to exist for years, even decades; (2) maintaining dual systems (paper, Zipline) at the same time is confusing and inefficient; and (3) the advantages of Zipline are compelling. 

    Conversions will be the most challenging part of rolling out Zipline. They will require significant time and work from researchers. But HSD will provide detailed instructions, expectations, and support. Watch for more information in the upcoming editions of zNews.

     

    Zipline Sneak Peek

    Zipline workflow diagram

    Zipline workflow diagram

    This is a small screen shot of the workflow diagram you will see in Zipline every time you look at one of your studies or an application related to your study (for example, a Status Report). The diagram is at the top of the screen, for a quick and easy view of the status of your study or application. This example shows what the diagram looks like for a new study application that is being prepared by a researcher. The application hasn't been submitted to the IRB yet, so it's in "Pre-Submission" state.

    See future issues of zNews for more sneak peeks of key Zipline screen shots!

     

    Get a Jump on the Jargon

    HSD is keeping jargon and name changes to the minimum necessary. But there are definitely a few new terms that you will need to understand. Each issue of zNews will describe one of them.

    SmartForm

    In Zipline, the term "SmartForm" refers to the web-based forms for answering questions. The SmartForms capture data that is not included in the IRB Protocol form and they have questions that "branch".  This is different from HSD's "PDF smart forms", which branch but are neither web-based, nor capable of capturing data.

     

    What's Next for zNews

    In the next zNews we'll take a closer look at the new IRB application form. Why the new name, what is the philosophy behind it, and how you can prepare yourself for using it. We'll also be announcing which teams and departments will be rolling out and on what dates!

     

  • For the Record - March 7, 2016 - Expanded Exempt Category 7

    Mar 8, 2016 at 9:17am

    Get Ready for Zipline

    Monthly Update

    HSD has embarked on a multi-year suite of projects (called Compass) to replace our paper process with an electronic system: Project Delta (office re-organization), Project Streamline (re-aligning our forms and processes), and Project Zipline (implementing an electronic IRB system). This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    Zipline is on schedule to begin a phased roll out May 31, 2016! Full scale testing begins this week, when a group of researchers will submit a test application and move it through the entire review process to work out any last minute issues with instructions, help text, and system functionality. HSD staff will also be reviewing test applications, conducting mock IRB meetings, and moving items through the Zipline system.

    Check your email inbox on March 16th for the first issue of zNews; a biweekly newsletter dedicated to Zipline roll out and implementation details. Here you will find information about when your department will be "going live," what you need to do to prepare, and what you will need to do with your currently approved studies.

    The countdown has begun!

    Read more about the projects in our flyers, and catch up with past Zipline news on the dedicated Zipline News page.

     


    More Studies Now Qualify for Exempt Status

    Implemented February 26, 2016

    The criteria for Category 7 exempt status have been changed to allow significantly more studies to qualify for exempt status. With this expanded category, exempt status can now be granted to non-federally-supported research in which:

    • Subjects are cognitively-competent adults, AND
    • Research procedures consist solely of benign interventions, interactions, or observations of behavior that do not involve:
      1. The collection of biological specimens, or
      2. The physical assessment of subjects' physical characteristics except for standard anthropometrics and vital signs
    • unless the information obtained is recorded in such a manner that the human subjects can be identified directly or through identifiers linked to the subjects; and any disclosure of the human subjects' information outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.

    This should significantly reduce work for researchers whose activities now qualify for exempt status, because exempt research does not need to comply with regulatory requirements about consent or an annual Status Report.

    Questions? Contact hsdinfo@uw.edu or see HSD's new documents about exempt research.

     


    Exempt Status is Now Valid for the Life of the Study

    Implemented February 26, 2016

    The previous policy of limiting exempt status to 5 years has been changed. Instead, exempt status is now valid for the life of the study. Until now, researchers had to re-apply for exempt status if the study was going to continue past 5 years.

     


    New Help and Information About Exempt Research

    Implemented February 26, 2016

    The SOP Exempt Determination document has been replaced by two documents with significantly more information, targeted at specific researcher needs:

    • WORKSHEET Exempt Determination describes all of the criteria for exempt status. It also includes definitions of key terms for example, the meaning of the words "anthropometrics", "benign", "cognitively-competent", and "vital signs" for the newly-expanded exempt Category 7.
    • GUIDANCE Exempt Research provides guidance and interpretation about various aspects of exempt research and the regulatory categories of exempt research.

    These documents should make it significantly easier for researchers to assess whether their research is likely to qualify for exempt status.

     


    Washington State IRB Fees

    Implemented December 1, 2015

    HSD has just learned that the Washington State IRB (WS-IRB) is now charging fees for all IRB review activities, when the research being reviewed is not directly funded or conducted by a state agency. This affects many UW researchers, because any UW study that involves obtaining human subjects data from a state agency must obtain IRB review from the WS-IRB.

    The WS-IRB webpage has the fee schedule and a FAQ section. Here are some important details from those websites:

    • The fees apply to existing studies as well as new studies. For example, a study already approved by the WS-IRB will now be required to pay a fee for each annual Status Report or for each Modification.
    • Note that a $1000 fee is now being charged for Confidentiality Agreements (a document required by state law for access to some identifiable state records).
    • The fees must be paid in advance.
    • The review process will now take longer, because the WS-IRB estimates that it will take 2-3 weeks for administrative processing of the fee, once payment is received. Review will not begin until the fee is paid.
    • There is a process for requesting a fee waiver. If you are approved for a fee waiver, please inform HSD so that we can share successful request rationales with other UW researchers.

     


    Researcher Signatures on Consent Forms

    Implemented February 26, 2016

    UW IRB policy has been changed to eliminate the requirement to have the person who obtains a subject's consent sign the consent form, unless the study:

    • Involves more than minimal risk and is obtaining documentation of subject consent, OR
    • The funding agency or sponsor requires the consenter's signature, OR
    • The regulations that apply to the study require the consenter's signature.
    For example, many industry contracts require researchers to comply with ICH-GCP E6 guidelines about Good Clinical Practice, which require the consenter's signature on the consent form. Neither the Common Rule nor the FDA human subjects regulations require the consenter's signature.

    The consenter signature requirement is being retained for more than minimal risk studies because HSD believes that this requirement adds value to the protection of human subjects in these studies.

    Implementation of this policy change includes the following:

    • The SOP Consent Documentation has been revised to reflect this change.
    • The TEMPLATE: Consent Form, Standard has been revised to include help text about this issue.
    • Studies that are not required to have the consenter sign the consent form are also not forbidden from doing so. In other words, they may voluntarily choose to have the consenter sign the consent form.
    • HSD staff and the IRB will not require researchers to remove the signature block/line for the consenter from consent forms for studies where the signature is not required, unless other changes to the consent form are being requested.

     


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. Please always use the latest forms and documents from our website. We use this newsletter to alert you to those new documents, and welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Exempt Category 7
    Document(s) NEW: WORKSHEET: Exempt Determination; GUIDANCE: Exempt Research
    Description New documents for assessing whether research may qualify for exempt status.
    Expected impact High
    Related changes REMOVED: SOP Exempt Determination; UPDATED: APPLICATION: Determination, Exempt Status (PDF); APPLICATION: Determination, Exempt Status (Word)
    Link for more information See the news article or the documents linked above.
    Implementation date

    February 26, 2016

     

    Topic Consent Form Signature
    Document(s) UPDATED: TEMPLATE: Consent Form, Standard; SOP Consent Documentation
    Description Elimination of the requirement for the consenter to sign the consent form if the study is minimal risk (see above article for exceptions)
    Expected impact Medium
    Related changes None
    Link for more information See the news article or the documents linked above.
    Implementation date

    February 26, 2016

  • Research News: OR Horizon: A Culture of Partnership

    Feb 19, 2016 at 12:41pm

    Check out our most recent newsletter: OR Horizon:A Culture of Partnership.

  • For the Record - February 1, 2016

    Feb 1, 2016 at 11:49am

    More Studies Will Qualify for Exempt Status

    Coming Soon!

    Look for an announcement in next month’s e-Newsletter about a significant change to the criteria for exempt status.

    What is exempt status? Exempt status is granted to human subjects research studies that involve minimal risk and whose methods fit into certain methodological categories. Having exempt status significantly reduces regulatory burden because:

    • The research undergoes an administrative HSD review, not IRB review;
    • The review is usually much faster;
    • Annual Status Reports are not required; and
    • Regulatory requirements about consent, consent elements, and consent forms do not apply.

    The pending change. Category 7 will be expanded to include more types of studies. This category will continue to be restricted to studies that are not federally-supported.

    Reason for the change. This change is based on a similar exempt category that was proposed in the pending revision to human subjects regulations and that is based on the very low risk associated with certain types of non-biomedical research. We are able to implement the change in advance of the revised regulations as long as the change is applied only to studies that are not federally-supported.

    Look for revised Category 7 soon!

     


    Zipline

    Monthly Update

    HSD has embarked on a multi-year suite of projects (called Compass) to replace our paper process with an electronic system: Project Delta (office re-organization), Project Streamline (re-aligning our forms and processes), and Project Zipline (implementing an electronic IRB system). This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    Currently, the official documentation of IRB approval is the signature and date of the IRB chair on the application form. Space has always been at a premium on HSD forms, and we’ve long struggled to maintain enough room for this signature block and any conditions of approval. This lack of space leads to low information content, with the result that the signature page is not very meaningful to anyone outside the UW.

    With Zipline, approval documentation will be provided with an official approval letter rather than a signature block on the form. The Zipline system has ten letter templates, one for each type of review outcome. HSD staff will be able to modify the templates to suit the specific circumstances of each study.

    Letters will provide researchers with more information as well as an official and recognizable record of review outcome that is easily understood by funding agencies, journal editors, and others needing official documentation.

    Some committees have been supplementing the signature page with approval letters for years, but now approval communications will be consistent across all IRBs; the letters will have a consistent look, format, and content; and all HSD teams will have the same training on letter writing.

    Read more about the projects in our flyers, and catch up with past Zipline news on the dedicated Zipline News page.

  • For the Record - January 5, 2016

    Jan 5, 2016 at 11:11am

    Happy New Year from HSD

    HSD is looking forward to bringing new and revised forms, updated standard operating procedures, and a new electronic IRB submission system to the UW research community. 2016 promises to be a year of exciting changes that will make it easier for you to navigate the IRB approval process!


    Genomic Data Sharing (GDS)

    Implemented December 24, 2015

    In 2015, the National Institutes of Health (NIH) implemented the NIH Policy on Genomic Data Sharing (GDS). It applies to all NIH-funded research that generates "large-scale" human or non-human genomic data as well as the use of those data for subsequent research. These requirements are an expansion of the 2008 NIH policy requiring submission of some types of genetic data to the NIH dbGaP database. An informative and well-organized website provides complete details, including information about the specific types of genomic data that are included in this policy.

    HSD has revised all of its documents that previously focused on the dbGaP requirement to include these expanded and new requirements. This includes the addition of a new Genomic Data Sharing section to the standard consent form template. A complete list of all documents related to the GDS policy is listed under “New and Revised Documents” at the end of this newsletter.

    KEY POINTS

    • Grant application. The GDS policy requires researchers to include in future NIH grant applications a basic plan for how they will comply with the Genomic Data Sharing requirements.
    • Which data. The GDS policy applies to far more types of genetic and genomic analyses than the previous dbGaP policy.
    • Database for deposition. The GDS policy allows researchers to submit their data to a wider variety of NIH databases than the dbGaP policy allowed.
    • Institutional certification. The GDS policy, like the dbGaP policy, requires an institutional certification to accompany the data when they are submitted to NIH. The certification process is conducted by HSD and the certification letter is signed by the Office of Sponsored Programs (OSP). The two policies differ, however, in that dbGaP did not require the certification to be obtained until the researcher was ready to send the data to NIH. The GDS policy requires certification as a Just-in-Time condition of award that must be fulfilled before NIH will release the grant funds.
      • Certification cannot be provided until HSD has conducted its review, which may also involve the IRB.
      • However, NIH will accept a provisional certification during the Just-in-Time award process, which can be provided directly by OSP without any involvement of HSD or the IRB. This can then be replaced later with the final, HSD-conducted, certification.
    • Consent for specimen use. The GDS policy requires researchers to obtain prospective consent for genomic analysis and data sharing from the subjects, even if the specimens will be anonymous to the researcher when they are collected (for example, de-identified residual clinical specimens). The GDS policy also describes specific information that must be provided to subjects during the consent process.

    WHERE TO FIND MORE INFORMATION

    Topic Office Location/Document
    Genomic Data Sharing NIH https://gds.nih.gov/index.html
    HSD GUIDANCE: Genomic Data Sharing
    Provisional Certification OSP osp@uw.edu
    Standard (Regular) Certification HSD How to apply for certification:
    SOP Request for Genomic Data Sharing Certification - Investigators
    Form to use when applying for certification:
    SUPPLEMENT: Genomic Data Sharing
    Criteria for obtaining certification:
    CHECKLIST: Genomic Data Sharing Certification
    Consent Requirements HSD TEMPLATE: Consent Form, Standard, OR CHECKLIST: Genomic Data Sharing Certification

     


    Zipline

    Monthly Update

    HSD has embarked on a multi-year suite of projects (called Compass) to replace our paper process with an electronic system: Project Delta (office re-organization), Project Streamline (re-aligning our forms and processes), and Project Zipline (implementing an electronic IRB system). This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    As amazing as it is to be implementing an electronic IRB submission system (Zipline!), it's just as important to talk about the new submission form that will go with it: the "IRB Protocol Form." Not to be confused with a research protocol, this new form will replace six different initial application forms. Researchers will no longer need to make a regulatory determination to figure out which form to use, because there will be just one form!

    The IRB Protocol Form is designed with the research process in mind. Taking into account requests from campus, the IRB Protocol questions are more aligned with the way a researcher thinks about their research. Questions have been added and updated to better elicit the information that HSD and the IRBs need to make determinations, with the goal of reducing the "back and forth".

    So not only will Zipline improve the IRB processes, but so will the new IRB Protocol Form. If you'd like to volunteer to help test the IRB Protocol form, please email Heather Rieck, Business Systems Analyst, at hrieck@uw.edu.

    Read more about the projects in our flyers, and catch up with past Zipline news on the dedicated Zipline News page.


    New WIRB Smart Forms

    Effective Monday, December 21st, Western IRB (WIRB) has published six smart forms that replace 20 of their older forms, including:

    1. Initial Review Form
    2. Modification/Change in Research Form
    3. Promptly Reportable Information (PRI) Form
    4. Continuing Review Site Report
    5. Continuing Review Sponsor Report
    6. Closure Report

    These new smart forms are dynamic, responsive PDFs that auto-populate based on the information you enter and automatically remove fields that don't apply to your research. They should make it faster and easier to submit WIRB IRB applications. HSD has modified its own SOPs and forms with updated links and instructions for these documents. Please use these for future WIRB submissions to HSD.


    Certificate of Confidentiality

    The National Institutes of Health (NIH) has released a short podcast explaining Certificates of Confidentiality and how to obtain them. The UW IRB strongly encourages researchers to obtain a Certificate when they are collecting sensitive identifiable research data that would likely harm the research participants if it was released. The Certificate allows researchers (and the University) to resist subpoenas and similar requests for identifiable research data.

    The podcast and a transcript are available here.


    Recruiting and Subject Payment Information

    The following documents and HSD pages about subject recruiting have been removed from the HSD website because: they are out of date compared with current regulatory guidance and practices; they are written in a way that suggests they are rules/requirements rather than the guidance they are intended to be.

    • Approaching and Recruiting Prospective Subjects
    • Approaching and Recruiting Prospective Subjects - Advertisements
    • Approaching and Recruiting Prospective Subjects Intermediaries
    • Approaching and Recruiting Prospective Subjects Pre-Screening Records
    • Approaching and Recruiting Prospective Subjects - Screening
    • Approaching and Recruiting Prospective Subjects - Telephone
    • Approaching and Recruiting Prospective Subjects Web-Based
    • Compensation of Subjects
    • Subject Payment (doc)
    • Subject Payment Confidentiality and Income Tax (doc)

    HSD recognizes that guidance is needed on these two topics. However, the inaccuracies and problems of the current documents and web pages have grown to outweigh their positive value. New (replacement) guidance will be created in late spring or early summer. In the meantime, please send any questions about these topics to hsdinfo@uw.edu.


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. Please always use the latest forms and documents from our website. We use this newsletter to alert you to those new documents, and welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Genomic Data Sharing
    Document(s) NEW: SOP Genomic Data Sharing Certification HSD Procedures; SOP Request for Genomic Data Sharing Certification Investigators; SUPPLEMENT: Genomic Data Sharing; GUIDANCE: Genomic Data Sharing; CHECKLIST: Genomic Data Sharing Certification
    Description New suite of forms and documents to support the NIH Genomic Data Sharing policy
    Expected impact High
    Related changes TEMPLATE: Consent Form, Standard  added block of text for when Genomic Data Sharing is involved; SOP Human Subjects Research  replaced reference to GWAS dbGaP guidance with Genomic Data Sharing; APPLICATION: Modification, Approved Project  Changed reference from GWAS dbGaP Supplement to Genomic Data Sharing
    Link for more information See the news article or the documents linked above.
    Implementation date

    December 24, 2015

     

    Topic Links to WIRB Smart Forms
    Document(s) UPDATED: REQUEST AUTHORIZATION: UW/WIRB; SOP WIRB Review - Research Procedures
    Description Updated links and instructions for completing a WIRB submission using their new smart forms
    Expected impact Medium
    Related changes None
    Link for more information See the news article or the documents linked above.
    Implementation date

    December 24, 2015

  • For the Record - December 7, 2015

    Dec 7, 2015 at 3:03pm

    Changes re Confidentiality Agreements

    Effective Immediately

    Confidentiality Agreements are required when researchers will access individually-identifiable confidential information owned by a UW administrative unit (e.g., UW medical records; student records), without first obtaining the consent of the individuals. New changes to the relevant HSD forms and documents should make it easier for researchers to obtain or revise Confidentiality Agreements.

    Revised processes

    • Researchers whose study is reviewed by another IRB (e.g., WIRB, the Hutch) instead of the UW IRB are no longer required to provide documentation of IRB approval and a HIPAA waiver in order to obtain a Confidentiality Agreement.
    • There are minor revisions to the process for modifying an existing Confidentiality Agreement.
    • Researchers are no longer required to provide a destruction date for identifiers.

    Increased clarity

    New processes


    Public Comment Period Extended for Proposed Regulations

    The Department of Health and Human Services and fifteen other Federal Departments and Agencies are extending by 30 days the comment period on the proposed revision to the Common Rule human subjects regulations. The proposed revisions are intended to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The new comment period deadline is January 6, 2016. Please see the OHRP website for information about the proposed revisions, including how to submit comments and how to view posted comments.


    PAVE Survey Results

    In May 2015 HSD's Post Approval Monitoring Program (PAVE) conducted a REDCap survey of researchers with active studies reviewed by a full IRB committee. The purpose of the brief, 7 question survey was to profile and identify studies that might benefit from additional monitoring by HSD. 433 unique researchers were identified to participate and 420/433 responded (a 97% response rate!). Thank you to everyone who made time to complete the survey. The results are included below:

    PAVE Overview
    Click for larger image

    Based on the results of the survey, the PAVE program will be piloting several changes to its routine site visits starting this December. More information about changes to the PAVE program will be provided in a future eNewsletter. Researchers involved in the pilot will be contacted directly. Questions? Contact Jason Malone, HSD Assistant Director for Regulatory Affairs, at jmmalone@uw.edu or 206-543-2254.


    Welcome New IRB Reliance Administrator

    Dr. Elizabeth Falsberg is our new IRB Reliance Administrator effective December 1, 2015. She replaces Brecken Cardinal, Clinical Trials Administrator, who accepted a position with Western IRB. Dr. Falsberg brings a breadth of regulatory knowledge and 10+ years of human subjects protection experience to the position. She has been with HSD since 2005, joining as a Review Coordinator before moving into an IRB Administrator position in 2007. She has reviewed full and minimal risk research in both the biomedical and social/behavioral arenas. She holds a PhD from the University of Washington in English. We hope you will join us in welcoming Dr. Falsberg to her new position.

    Dr. Falsberg will be slowly transitioning into her new role through the month of December. Please continue to send any WIRB, CC-IRB or other related inquiries to hsdrely@uw.edu or call our main office line 206-543-0098 for assistance.


    REMINDER Changes to CITI and HSD Training Lookup Tool

    HSD is updating our process for online researcher training, including changes to CITI offerings and our system for training documentation. On CITI, we now offer one course in the protection of human subjects, called Human Subjects Learners. This course is appropriate for researchers in all disciplines and it serves as both a "basic" and a "refresher" course. It is shorter than the old CITI courses, providing mostly the same information but in a streamlined format.

    As part of our process update, we are retiring our training documentation lookup tool. New training completions are now only available through CITI. The tool will be available for documentation download until July 1, 2016, at which point it will be taken off our website. If you took an in-person training prior to HSD's use of CITI, you should obtain and save documentation from our lookup tool prior to July 1, 2016.

    The certificate of completion provided to you directly from the source of training (ex CITI or NIH PHRP) should be retained by you indefinitely and provided as documentation of training to any sponsors or collaborating institutions that require the training.


    2016 Update to the International Compilation of Human Research Standards

    The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines that govern human subjects research in 120 countries, as well as the standards from a number of international and regional organizations. The Compilation was developed for use by researchers, IRBs, and others.

    The 2016 edition is now available online: http://www.hhs.gov/ohrp/international/index.html. The updated edition includes hundreds of updates from the previous edition. Seven new countries are included in the 2016 edition: Burkina Faso, Cote-d'Ivoire, Cuba, Sri Lanka, Trinidad and Tobago, United Arab Emirates, and Uzbekistan.


    Autumn 2015 Road Show Online

    If you missed Karen Moe's presentations last month, please visit our website for a recording, and the slides. This presentation includes information about:

    • Zipline, the upcoming online IRB submission system
    • Changes to CITI training offerings
    • The Notice of Proposed Rulemaking (NPRM)
    • Genomic data sharing

    Visit the HSD Training Videos page.

     


    Compass

    Monthly Update

    HSD has embarked on a multi-year suite of projects (called Compass) to replace our paper process with an electronic system: Project Delta (office re-organization), Project Streamline (re-aligning our forms and processes), and Project Zipline (implementing an electronic IRB system). This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    As 2015 swiftly winds to a close, HSD leadership would like to thank our staff and the research community for their patience with our major staffing model reorganization (project Delta). Here's a look back at the why, the how, and the end results.

    The Human Subjects Division began as a very small office. As research administration needs grew and changed, HSD slowly added staff as resources became available. By the end of 2014, HSD had 13 small teams with highly specialized functions and knowledge. This model created silos, disparity of information across the teams, and a communication structure that could baffle a new researcher.

    When our new structure "went live" on July 1, 2015, 13 small teams were consolidated into five larger teams, each supporting an Institutional Review Board (IRB). A new position was created: the Team Operations Lead (TOL), to manage each team, ensure consistency, and serve as the single point of contact for researchers. When combined with a recently-completed five-month training program, the re-organization is creating a flexible staff of regulatory experts with experience across many types of review.

    At the same time, the assignment of departments to specific IRBs was revised to equalize workload across the IRBs, and some existing studies were transferred to different IRBs so that all of a researcher's studies (new and existing) are now reviewed by the same IRB. This is creating stronger connections between researchers and our staff, while also reducing the sensation of being “passed around the office.”

    The implementation of our new structure has set us up for success as we plan to implement Zipline, our electronic submission system.

    Thanks again to everyone for working with us through this transition!

    Read more about the projects in our flyers, and catch up with past Zipline news on the dedicated Zipline News page.


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. Please always use the latest forms and documents from our website. We use this newsletter to alert you to those new documents, and welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Confidentiality Agreements
    Document(s) NEW: SOP Obtaining and Modifying a Confidentiality Agreement REVISED: GUIDANCE: Confidentiality Agreement; REPORT CHANGE: Confidentiality Agreement; TEMPLATE: Confidentiality Agreement
    Description Clarifications to instructions, and a new SOP regarding when and how to obtain and modify a Confidentiality Agreement.
    Expected impact Medium
    Related changes None
    Link for more information See the news article or the documents linked above.
    Implementation date

    Immediately

  • For the Record - November 2, 2015

    Nov 2, 2015 at 12:47pm

    Guidance on HSD Administrative Fee

    In response to researcher and departmental request, HSD has released a new guidance document on the HSD administrative fee and when it applies. This does not represent a new fee but instead one that is already being applied to studies that are BOTH industry initiated and industry sponsored. Researchers and departments can now point sponsors with questions about this fee to the new guidance document posted on our website. Anyone with questions about this fee can email hsdrely@uw.edu


    Autumn 2015 Road Shows

    There is still one more chance to have your questions answered and hear Director Karen Moe talk about changes coming to HSD's operations, policies and procedures. This presentation will include information about:

    • Zipline, the upcoming online IRB submission system
    • Changes to CITI training offerings
    • The Notice of Proposed Rulemaking (NPRM)
    • Genomic data sharing

    This last session will also be webcast. Use this link to join: http://uofw.adobeconnect.com/hsdfall2015/

    Place Time Date
    UW Tower Auditorium 9:00 to 10:30 am Wednesday, Nov. 4

    A recording of one of the previous sessions, along with the PDF version of the slides, will be available shortly on HSD's website on the HSD Training Videos page.

     


    REMINDER: Zipline Go-Live Date!

    Monthly Update

    We want to remind the campus community that the pilot phase of Zipline will go live on May 31, 2016! Our project staff are working diligently toward completion of many process changes, software configurations, training development, and other major milestones in preparation for this achievement. Stay on the look out for more information regarding the training, rollout, and support plans in future communications.

    Read more about the projects in our flyers, and catch up with past Zipline news on the dedicated Zipline News page.


    REMINDER: Webinars about the Proposed Changes to the Common Rule

    The federal Office of Human Research Protections has released six free webinars describing the proposed changes to the Common Rule. This is a great way to learn about the specific proposed changes. The webinars are:

    1. Overview of the NPRM (34 minutes)
    2. Exclusions and Exemptions (30 minutes)
    3. Informed Consent (28 minutes)
    4. IRB Review and Operations (18 minutes)
    5. Research with Biospecimens (22 minutes)
    6. Secondary Research Use of Data (21 minutes)

    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. Please always use the latest forms and documents from our website. We use this newsletter to alert you to those new documents, and welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic HSD Administrative Fee
    Document(s) NEW: GUIDANCE: HSD Administrative Fee
    Description Outlines HSD's existing policy regarding an administrative fee applied to studies that are both industry initiated and industry funded.
    Expected impact Low
    Related changes None
    Link for more information See the news article or the documents linked above.
    Implementation date

    October 30, 2015

  • For the Record EXTRA - Road Show Reminder

    Oct 14, 2015 at 10:30am

    Autumn 2015 Road Shows

    This fall, Human Subjects Division (HSD) Director Karen Moe will be making presentations to the UW research community regarding changes coming to HSD's operations, policies and procedures. These presentations will include information about:

    • Zipline, the upcoming online IRB submission system
    • Changes to CITI training offerings
    • The Notice of Proposed Rulemaking (NPRM)
    • Genomic data sharing

    The sessions will take place at the times and locations listed below. One session will be recorded and uploaded to our website for those who are unable to attend.

    Place Time Date
    Health Sciences, Turner Auditorium 1 to 2:30 pm Wed., Oct. 21
    Kane Hall, Walker Ames Room 9 to 10:30 am Wed., Oct. 28
    Harborview, R&T Auditorium 1 to 2 pm Wed., Oct. 28
    UW Tower Auditorium 9 to 10:30 am Wed., Nov. 4

     


    Changes to CITI and HSD Training Lookup Tool

    HSD is updating our process for online researcher training, including changes to CITI offerings and our system for training documentation. On CITI, we now offer one course in the protection of human subjects, called Human Subjects Learners. This course is appropriate for researchers in all disciplines and it serves as both a "basic" and a "refresher" course. It is shorter than the old CITI courses, providing mostly the same information but in a streamlined format.

    As part of our process update, we are retiring our training documentation lookup tool. New trainings will not be added to the lookup tool after November 1, 2015. The tool will be available until July 1, 2016, at which point it will be taken off our website. The certificate of completion provided to you directly from the source of training (ex. CITI or NIH PHRP) should be retained by you indefinitely and provided as documentation of training to any sponsors or collaborating institutions that require the training. In addition, documentation of CITI training for individuals using the UW CITI portal may also be found in the MyResearch Training Transcript tool.

  • For the Record - October 5, 2015 - Zipline Go-Live Date Announced

    Oct 5, 2015 at 10:19am

    Zipline Go-Live Date!

    Monthly Update

    HSD has embarked on a multi-year suite of projects to replace our paper process with an electronic system: Project Delta (office re-organization), Project Streamline (re-aligning our forms and processes), and Project Zipline (implementing an electronic IRB system). This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    We are excited to announce that the pilot phase of Zipline will go live on May 31, 2016! Our project staff are working diligently toward completion of many business process changes, software configurations, training development, and other major milestones in preparation for this achievement.

    The rollout will start with a pilot phase. It will begin with one HSD team and a small set of UW campus departments submitting new studies only. These HSD staff and researchers will then provide feedback to Zipline project staff regarding any needed changes to training, processes, forms, or technologies prior to full campus implementation.

    User acceptance testing of Zipline will conclude in late October. We want to thank all the staff, researchers and research staff, and IRB members who volunteered to participate in the testing. Your feedback is invaluable!

    We are still developing our implementation plan which includes a training plan and schedule, go-live support plan, and detailed rollout timeline (e.g., when each department will be phased into Zipline). Look for more information in upcoming eNews publications.

    Read more about the projects in our flyers, and catch up with past Zipline news on the dedicated Zipline News page.


    Autumn 2015 Road Shows

    This fall, Human Subjects Division (HSD) Director Karen Moe will be making presentations to the UW research community regarding changes coming to HSD's operations, policies and procedures. These presentations will include information about:

    • Zipline, the upcoming online IRB submission system
    • Changes to CITI training offerings
    • The Notice of Proposed Rulemaking (NPRM)
    • Genomic data sharing

    The sessions will take place at the times and locations listed below. One session will be recorded and uploaded to our website for those who are unable to attend.

    Place Time Date
    Health Sciences, Turner Auditorium 1:00 to 2:30 pm Wednesday, Oct. 21
    Kane Hall, Walker Ames Room 9:00 to 10:30 am Wednesday, Oct. 28
    Harborview, R&T Auditorium 1:00 to 2:00 pm Wednesday, Oct. 28
    UW Tower Auditorium 9:00 to 10:30 am Wednesday, Nov. 4
     

    Changes to CITI Online Researcher Training

    HSD is in the process of updating our system for online researcher training in the protection of human subjects. So far, we have revamped the human subjects offerings available on CITI (www.citiprogram.org).

    Previously, there were a number of different CITI human subjects trainings available, including multiple options for basic and refresher courses. These trainings were often long and time consuming to complete. We have changed our system so there is now only one human subjects training option on CITI. This training is appropriate for all types of researchers and it can be used as both a basic course and as a refresher. This training is called "Human Subjects Learners". It is shorter than the previous courses, with 8 standard modules and up to 9 optional modules.

    Take the CITI course "Human Subject Learners" to fulfill any of your human subjects training needs. For more information, go to http://www.washington.edu/research/hsd/courses/. More updates about changes to our online training system will be coming soon.


    Webinars about the Proposed Changes to the Common Rule

    The federal Office of Human Research Protections has released six free webinars describing the proposed changes to the Common Rule. This is a great way to learn about the specific proposed changes. The webinars are:

    1. Overview of the NPRM (34 minutes)
    2. Exclusions and Exemptions (30 minutes)
    3. Informed Consent (28 minutes)
    4. IRB Review and Operations (18 minutes)
    5. Research with Biospecimens (22 minutes)
    6. Secondary Research Use of Data (21 minutes)

    Dual Use Research of Concern (DURC)

    New Federal Policy as of September 24, 2015

    The new policy applies to all research involving botulinum neurotoxin at any quantity or a subset of select agents. The research personnel must complete an online training module through UW Environmental Health & Safety (EH&S), and a Dual Use Research of Concern (DURC) application must be submitted to the UW's Institutional Biosafety Committee. See EH&S's DURC website (https://www.ehs.washington.edu/rbsresplan/durc.shtm) for more information.


    Contact HSD

    The contact page for HSD staff has been updated both to reflect our new organizational structure, and to indicate that the Team Operations Lead (TOL) is the main contact for each team. Please contact the TOL if your application is new, you are just beginning to work with a specific team, or you are not sure who to contact. Once your application has been assigned to an Administrator, feel free to maintain contact with that person.

    We hope that the updates help you to find the correct contact swiftly and easily.

  • For the Record - September 14, 2015

    Sep 14, 2015 at 9:46am

    Proposed Revisions to the Human Subjects Regulations

    In case you missed the September 2nd For the Record: Extra, the federal Office for Human Research Protections (OHRP) has released its proposed revisions to the human subjects regulations. The 90-day public comment period ends on December 7, 2015. The agency will consider the public comments before publishing the final regulations ("Final Rule"), which may take months or years. The regulations will generally take effect one year after that publication. HSD will keep the research community informed of the progress of the revision process, including HSD's development of a robust communication, training, and implementation plan.


    Reminder: Slower Turnaround Times

    We appreciate the patience and kindness that many researchers have expressed while HSD completes the training and adjustments required by our recent staff re-organization. We are returning to our normal turnaround times for most activities, but we expect occasional short-lived bottlenecks to continue for another month. Again, thank you for your patience!


    Exempt Category 2 - Definition of "Task"

    Exempt status can be awarded to human subjects research that is minimal risk and that fits into one of six methodological categories. Annual Status Reports and Modification requests are generally not required of exempt studies.

    Exempt Category 2 is for research involving the use of tests, surveys, interviews, or observations of public behavior. If the research involves a "task", it does not qualify for this exempt category. The definition of "task" has been clarified at length in the revised SOP Exempt Determination. The clarifications are likely to slightly expand the number of studies that qualify for this exempt status.


    Improved Instructions for ClinicalTrials.gov Registration

    The HSD instruction documents that guide researchers through the federally-required clinical trials registration process have been consolidated and shortened for clarity and ease of use. See the Clinical Trials Registration section of part 6 on our Policies, Procedures and Guidance web page.


    Quarterly Metrics Report

    Posted September 8, 2015

    A new edition of the HSD Performance Metrics Report has been published and posted to the HSD website. It describes workload and turnaround times for steps and sequences of the IRB review process for the period 1/1/15 through 6/30/15.


    Reminder: Confidentiality Agreement Template

    Beginning October 1, HSD will no longer accept Confidentiality Agreements created with outdated templates. This form is required when UW records will be obtained and used for research, without the consent of the subjects.

    HSD has been reluctant to impose this restriction, because we understand how much work can be involved in getting the sometimes numerous signatures for this form. However, the current template for the Confidentiality Agreement was revised at the end of May with changes that are especially important when the research is being reviewed by another IRB (such as WIRB or the Cancer Consortium IRB). Please replace your downloaded copies with the current version. 


    Zipline

    Monthly Update

    HSD has embarked on a multi-year suite of projects to replace our paper process with an electronic system: Project Delta (office re-organization), Project Streamline (re-aligning our forms and processes), and Project Zipline (implementing an electronic IRB system). This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    User Acceptance Testing (UAT) of Zipline began on September 8. UAT is a phase of software development in which the software is tested in the "real world" by the intended audience or a business representative.

    Testing is necessary to ensure that Zipline is error free, fulfills business requirements, and can support the day-to-day business of submitting and reviewing IRB applications. UAT will also help inform HSD regarding user training needs.

    During this phase of testing, only Zipline will be considered. This means that testing of forms (Streamline) will be completed in a separate phase.

    Researchers, HSD staff, and IRB members have been selected to complete a series of case studies designed to mimic real-world submission and review scenarios.

    During these sessions, facilitators will be standing by to log questions and issues that testers discover. Critical issues that are discovered will be resolved, and another round of UAT will be completed for the discovered issues. We expect that this process will be complete by late November.

    Read more about the projects in our flyers, and catch up with past Zipline news on the dedicated Zipline News page.


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. Please always use the latest forms and documents from our website. We use this newsletter to alert you to those new documents, and welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic ClinicalTrials.gov
    Document(s) UPDATED: ClinicalTrials.gov - Instructions for Registering Your Trials, ClinicalTrials.gov - Instructions for Responsible Party and Releasing a Study Record, ClinicalTrials.gov - Instructions for Updating a Study Record Every 6 Months, ClinicalTrials.gov - Q and A for Registering Studies
    Description Updated the HSD contact, removed outdated information.
    Expected impact Medium
    Related changes REMOVED: ClinicalTrials.gov - Results Registration, ClinicalTrials.gov - Transferring a Study Record
    Link for more information See the news article or the documents linked above.
    Implementation date

    August 28, 2015

     
    Topic Exempt Category 2
    Document(s) UPDATED: SOP Exempt Determination
    Description Clarifications to the term "task"
    Expected impact Medium
    Related changes UPDATED: APPLICATION: Determination, Exempt Status (WORD & PDF)
    Link for more information See the news article or the documents linked above.
    Implementation date

    August 28, 2015

     

  • For the Record EXTRA - Proposed Revision of Federal Regulations Just Released

    Sep 2, 2015 at 9:19am

    The proposed revisions to the federal human subjects regulations have just been released by the federal Office of Human Research Protections (OHRP). They are available at this link (note that the document is 519 pages long). The most significant changes are summarized at the bottom of this announcement.

    Timeline and process

    OHRP is following the standard federal process for revising regulations. See the table below.

    Event Time
    Advance Notice of Proposed Rulemaking (ANPRM) Announcement of the intention to change the regulations, and the nature of the changes that are likely July 26, 2011
    Public comment period July 26 - October 26, 2011
    Notice of Proposed Rulemaking (NPRM) The draft of the revised regulations. Made public on September 2, 2015; Published in the Federal Register on September 8, 2015
    Public comment period The mechanism for submitting public comments will not be available until September 8, 2015 September 8 - December 7, 2015
    Final Rule Release of the final regulations, and announcement of the implementation date Unknown time (months, years) after the public comment period
    Implementation Date The date when the revised regulations take effect Often one year after the release of the Final Rule

    Submitting a comment

    OHRP is soliciting comments September 8 to December 7 through: a website,  email, mail, and  a town hall meeting in Washington D.C. The website and addresses are not yet available, but HSD will send out the information when we receive it. Comments can be submitted by everyone.

    HSD will be submitting a comment, after careful consideration of the impact on researchers, research participants, and the IRB. If you would like HSD to consider your opinion about any of the changes, please email hsdinfo@uw.edu and put "Regulation changes" in the subject line.

    Staying informed

    See future editions of this newsletter for additional news and analysis.

    The most significant proposed changes

    This section is from the announcement released September 2, 2015 by the federal Office of Human Research Protections.

    Some of the major changes being proposed that will better protect research subjects and help build public trust are the rules relating to informed consent. With regard to informed consent in general (such as consent to participating in clinical trials), the rules would be significantly tightened to make sure that the process becomes more meaningful. Consent forms would no longer be able to be unduly long documents, with the most important information often buried and hard to find. They would need to give appropriate details about the research that is most relevant to a person’s decision to participate in the study, such as information a reasonable person would want to know, and present that information in a way that highlights the key information. In addition, to assure that these rules do indeed change current practices, there will be a one-time posting requirement for the consent forms for clinical trials, so that anyone drafting a consent form will do so knowing that it will eventually be subject to public scrutiny.

    In addition, informed consent would generally be required for secondary research with a biospecimen (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. Such consent would not need to be obtained for each specific research use of the biospecimen, but rather could be obtained using a "broad" consent form in which a person would give consent to future unspecified research uses.

    The NPRM also attempts to strengthen the effectiveness and efficiency of the oversight system by making the level of review more proportional to the seriousness of the harm or danger to be avoided. Research that poses greater risk to subjects should receive more oversight and deliberation than less risky research. The NPRM seeks to avoid requirements that do not enhance protection and impose burden, which can decrease efficiency, waste resources, erode trust, and obscure the true ethical challenges that require careful deliberation and stakeholder input. Cumbersome and outdated regulatory standards overwhelm and distract institutions, IRBs, and investigators in ways that stymie efforts to appropriately address the real risks and benefits of research.

    The result of these types of changes, as the NPRM proposes to implement them, is that some studies that currently require IRB review would now become exempt. Some that are currently exempt would specifically be declared as outside the scope of the regulations (“excluded”), and thus would not require any administrative or IRB review. Further, in terms of determining when a study is exempt, a web-based “decision tool” will be created. That decision tool will provide a determination of whether or not a study is exempt. That result, so long as the tool was provided with accurate information, will be presumed by the Common Rule agencies to be an appropriate determination of exempt status. It is expected that in many instances the tool would be used by the investigators themselves, thus obviating both the need for further review and the concern that the institution might be subjecting itself to future liability by allowing investigators to use the tool. For all of the excluded and exempt research activities, this NPRM also affirms the importance of applying the ethical principle of respect for persons, in addition to the importance of abiding by this principle in fully regulated non-exempt research involving human subjects.

    1. Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects, and the manner in which it is given to them, to better assure that subjects are appropriately informed before they decide to enroll in a research study.
    2. Generally require informed consent for the use of stored biospecimens in secondary research (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. That consent would generally be obtained by means of broad consent (i.e., consent for future, unspecified research studies) to the storage and eventual research use of biospecimens.
    3. Exclude from coverage under the Common Rule certain categories of activities that should be deemed not to be research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.
    4. Add additional categories of exempt research to accommodate changes in the scientific landscape and to better calibrate the level of review to the level of risk involved in the research. A new process would allow studies to be determined to be exempt without requiring any administrative or IRB review. Certain exempt and all non-exempt research would be required to provide privacy safeguards for biospecimens and identifiable private information. New categories include:
      • Certain research involving benign interventions with adult subjects;
      • Research involving educational tests, surveys, interviews or observations of public behavior when sensitive information may be collected, provided that data security and information privacy protections policies are followed
      • Secondary research use of identifiable private information originally collected as part of a non-research activity, where notice of such possible use was given
      • Storing or maintaining biospecimens and identifiable private information for future, unspecified secondary research studies, or conducting such studies, when a broad consent template to be promulgated by the Secretary of HHS is used, information and biospecimen privacy safeguards are followed, and limited IRB approval of the consent process used is obtained.
    5. Change the conditions and requirements for waiver or alteration of consent such that waiver of consent for research involving biospecimens (regardless of identifiability) will occur only in very rare circumstances.
    6. Mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions. To encourage the use of IRBs that are otherwise not affiliated with or operated by an assurance-holding institution (“unaffiliated IRBs”), this NPRM also includes a proposal that would hold such IRBs directly responsible for compliance with the Common Rule.
    7. Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.
    8. Extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.

    In sum, the proposed modifications described above are designed to continue to uphold the ethical principles upon which the Common Rule is based, as applied to the current social, cultural, and technological environment.

  • For the Record - August 3, 2015

    Aug 10, 2015 at 3:45pm

    Slower Turnaround Times through September

    Especially for Minimal Risk and Exempt reviews

    The combination of internal promotions, new hires, and revised roles and responsibilities means that almost everyone in HSD will be doing some unfamiliar work this summer.

    Intensive hands-on training is being provided now and through the rest of the summer to HSD staff. In addition we are implementing a modest increase in our work capacity during this time. We nonetheless expect that turnaround times will be significantly slower through September while we adapt to our new organizational structure and processes. After this transition, we expect turnaround times to return to previous levels, and then to start reaping the benefits of increased consistency, better tracking of items, and more flexibility in handling workload fluctuations.

    We appreciate your patience. We are working hard to make the transition as smooth as possible. In the meantime, be sure to let us know if any IRB reviews you need during this time are truly urgent. Attach a memo on top of your application materials or send an email to your staff contact or to hsdinfo@uw.edu.


    Important Reminder-NSF Awards

    NSF long-standing policy. Researchers who have applied for National Science Foundation (NSF) grants should remember that NSF program officers cannot make awards until an IRB approval or exemption determination has been received by NSF. NSF's approach to this issue is different than for NIH awards.

    New NSF elaboration on the policy. In this year's Grant Proposal Guide (Chapter II.d.8), NSF elaborated that: "The only acceptable Institutional Review Board (IRB) approval documents are those that approve a human subjects research protocol; approvals 'in concept' are not acceptable. The NSF also cannot accept any IRB document that qualifies conditions that must be met before human subjects work can be carried out".

    Very short time requirements. In the past month HSD has heard from researchers who were given just 5 days - and in one case just 24 hours - to obtain IRB approval or lose the award. HSD cannot guarantee that approval will be granted in such short time frames. We will do everything possible, but there are no shortcuts through the regulatory process.

    What can you do?

    • Pay attention to every communication from your NSF contacts. If you hear something like, "The funding situation looks promising", prepare and submit your IRB application immediately! Do not wait for official or certain confirmation that your grant will be funded.
    • Do not expect a Delayed Onset Research Determination (DOHR) to solve the problem. Though NSF will accept a DOHR determination from HSD under very limited circumstances in which preliminary or other conceptual work must occur before human subjects work, they require a strong rationale and justification for the DOHR determination.
      • NSF has stated that a DOHR determination "will not be accepted for simple delays or oversights on the part of the researcher or for expediency in processing an award at the end of the fiscal year".
      • if you think your award may qualify for a DOHR determination, prepare and send HSD your DOHR application immediately. In addition, NSF requires that you "notify the cognizant NSF Program Officer assigned to the proposal. In such a case, NSF may add conditions to the award that prevent any research involving human subjects from being carried out, and otherwise restrict the drawing down of funds, until IRB approval has been obtained".
    • Contact your HSD team as soon as possible. Do not wait until you have your IRB application ready. Identify your team through the HSD CONTACTS webpage.
      • Do not count on getting through by phone right away, as your contact may have his/her phone on voice mail while they are working on someone else's NSF funded IRB application. Call, but leave a voice mail message if you don't reach the person.
      • Send an email as well, to at least two people, such as:
        • The HSD person you've worked with before
        • The Team Operations Lead of your HSD team
        • An Assistant Director of Operations (Emily Guthrie or Maria Savage)

    Newborn Dried Bloodspots

    NEW NIH Guidance
    Posted July 23, 2015

    HSD previously announced (June 1, 2015 For the Record) the new federal law that significantly impacts research with newborn dried bloodspots (NDBS).

    NIH has now released preliminary guidance about the law for investigators engaged in newborn screening related research: NOT-OD-15-127 July, 23 2015.

    The new requirements, as described previously:

    1. The law defines research with de-identified NDBS as being "human subjects research". This means that it must undergo IRB review. Previously, research with de-identified NDBS was not considered "human subjects research" and therefore did not require IRB review.
    2. The law eliminates an IRB's ability to waive the requirement to obtain informed consent for the use of NDBS. This means that parental consent must be obtained in order to use NDBS. Practically speaking, this means that consent must be obtained at the time the newborn sample is taken, and it must be consent for future, unspecified uses.

    These requirements apply to:

    • Activities that meet the federal definition of "research", and
    • Are funded by the federal Department of Health and Human Services (HHS), and
    • Use NDBS collected on or after March 16, 2015.

    REMINDER: WIRB Process Revisions

    On June 1, 2015, the TEMPLATE: Consent Form, UW/WIRB was significantly revised to:

    1. Combine the non-Clinical Pharmacology Unit (CPU) and CPU templates,
    2. Include much less required language, and
    3. Allow more flexibility.

    Additionally, the REQUEST AUTHORIZATION: UW/WIRB was modified to reflect changes in the overall process. Since implementation, we have allowed researchers to use the previous version of the consent template and authorization request. However, we will no longer accept these as of September 1, 2015. Please ensure that starting September 1, 2015, your WIRB requests sent to HSD use the current version of the TEMPLATE: Consent Form, UW/WIRB (version 3.70) and REQUEST AUTHORIZATION: UW/WIRB (version 4.70).


    Zipline

    Monthly Update

    HSD has embarked on a multi-year suite of projects to replace our paper process with an electronic system: Project Delta (office re-organization), Project Streamline (re-aligning our forms and processes), and Project Zipline (implementing an electronic IRB system). This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    Streamline: Sensible Simplification (of our forms, documents, and processes.)

    Project Delta has been completed, and we are ready to continue on to one of the most visible Streamline updates: the restructuring of our forms.*

    The "grand dame" of HSD forms, the "13-11" has been in circulation since the 1980's, when the UW had a centralized form creation group and before the rise of the microcomputer and desktop word processing. The main IRB application form was number 13-11, and the name has stuck. Over the years, the need to gather more regulatory information from researchers lead to the proliferation of more specialized forms, such as for medical record reviews, requesting exempt determinations, and creating repositories. The researcher currently has to make a high-stakes decision about which form is the correct one to use.

    Now we have the perfect opportunity to lessen that administrative burden. We hope to reduce the number of main applications to one or two, ask fewer regulatory questions, and elicit the information that HSD and the IRBs need to make determinations and decisions without stumping the researchers.

    We invite you to fill out this short survey to share with us the most frustrating aspects of our forms, as well as give us suggestions for how to improve. We'll be testing the new "Research Plan" (the new name of our initial application) this fall, and you are welcome to be a part of that process. Simply check "yes" at the end of the survey to indicate your interest in participating as an application tester.

    *You might wonder "why are there still forms? Isn't HSD going electonic?" This is because Zipline captures primarily the basic data needed for reporting. All other information needed to make determinations and review applications will be provided on electronic versions of Word forms that will be uploaded to and managed inside the Zipline system.

    Read more about the projects in our flyers, and catch up with past Zipline news on the dedicated Zipline News page.

  • For the Record - July 6, 2015

    Jul 6, 2015 at 12:30pm

    Record #50,000

    A Milestone Reached

    50,000

    On June 24th, a study coordinator dropped off a new IRB application at the HSD office that became record #50,000 in our database - an indication of how long the UW IRB has been in operation as well as the vigor of the UW research enterprise.

    In honor of the occasion, HSD is giving special rush service to the application:

    • Dr. Donald Fogelberg
    • Department of Rehabilitation Medicine
    • "Sleep Disturbance in Spinal Cord Injury: Identifying Symptoms and Risk Factors (SCI Sleep Study)"
    • HSD #50,000

    HSD Office Re-Structuring Completed

    Implemented July 1, 2015

    The re-organization of HSD review teams has been completed. Teams were merged from 13 small and highly specialized groups to five larger teams with greater breadth and depth of expertise. A new position - Team Operations Lead - was created for each team. See the revised HSD organizational chart. This completes one of the three related projects from our Compass Project Portfolio. Work continues on projects Streamline and Zipline (eIRB).

    One primary purpose of the re-organization is to break down the "silos" between Exempt, Minimal Risk, and Full Board review work. Staff have completed more than half of an intensive core training curriculum to create more experts, more expertise - the goal for this major undertaking. Each team has been assigned a portfolio of campus departments and will conduct all types of activities for those departments. This change will also improve review consistency and help balance workload fluctuations.

    How to find your Team. The assigned Team Operations Lead is the primary contact person for a department. To find your Team Operations Lead, use the Contact Lookup Tool located under Not sure who you need? on the HSD Contacts Page. Also, all members of each team are listed on the HSD Contacts Page.


    Slower Turnaround Times in July and August

    Especially for Minimal Risk and Exempt reviews

    The combination of internal promotions, new hires, and revised roles and responsibilities means that almost everyone in HSD will be doing some unfamiliar work in July and August.

    Intensive hands-on training is being provided now and through the rest of the summer to HSD staff. In addition we are implementing a modest increase in our work capacity during this time. We nonetheless expect that turnaround times will be significantly slower in July and August while we adapt to our new organizational structure and processes. After this transition, we expect turnaround times to return to previous levels or better, and to start reaping the benefits of increased consistency, better tracking of items, and more flexibility in handling workload fluctuations.

    We appreciate your patience. We will work hard to make the transition as smooth as possible. In the meantime, here are some suggestions for how you can help minimize the impact on your work:

    • Be sure to let us know if any IRB reviews you need during this time are truly urgent. Attach a memo on top of your application materials, or send an email to your staff contact or to hsdinfo@uw.edu.
    • Keep in mind that applications and materials submitted during the first two weeks of July are likely to be most affected by this transition.

    Local Conference on Informed Consent

    Deep registration discount for UW employees & students

    The Northwest Association for Biomedical Research (NWABR) is hosting a human subjects research conference on "Revolutionizing Informed Consent: Best Practices That Leverage Innovation and Technology". Because the UW is a member of NWABR, all UW employees and students who attend the conference are eligible for a member discount.

    Use the code UDUBMEMBER when you register, and your registration/conference fee will be $295 instead of $450. To register or find out more, see http://conferences.quorumreview.com/nwabr-revolutionizing-informed-consent-conference/. Continuing education credits are available (CME, CNE, CIP).

    Conference information:

    • Date: Wednesday, July 23, 2015
    • Time: 8:00 am - 5:00 pm
    • Location: Bell Harbor Conference Center on the Seattle waterfront
    • Meals: Lunch, morning & afternoon breaks are included in the registration fee
  • For the Record EXTRA - June 17, 2015 - REMINDER: HSD Closed July 1st

    Jun 17, 2015 at 12:04pm

    REMINDER - HSD Closed on July 1st

    The HSD office will be closed on Wednesday, July 1st

    Beginning on that day, HSD staff will be reorganized into new and larger teams. The office closure will allow us to complete the necessary physical moving of work spaces and files as well as other transition activities.

    The following activities and resources will remain open and staffed:

    • The HSD front desk on the 17th floor of the UW Tower.
    • The main HSD phone line: 206.543.0098.
    • The HSD help email address: hsdinfo@uw.edu (monitored only for urgent items).
    • Emergencies and urgent situations will continue to be handled but should be directed to the main HSD phone line or help email address rather than specific HSD staff.
  • For the Record - June 1, 2015 WIRB Process Updates

    Jun 1, 2015 at 12:52pm

    WIRB-Reviewed Industry Trials

    Implementation: June 1, 2015

    The process by which researchers obtain HSD authorization to send industry trials to WIRB for review is now significantly easier and faster, due to coordinated changes among HSD, the Office of Sponsored Programs (OSP), and the Clinical Research Budget and Billing Office (CRBB). Highlights include:

    • Relationship between HSD and OSP process. The IRB review and contract negotiations can now occur in parallel rather than sequentially. HSD and researchers no longer need to wait until the contract is finalized in order to complete the HSD authorization process and to send the IRB application to WIRB.
    • Relationship between HSD and CRBB processes. HSD no longer needs to wait for CRBB's assessment before completing the WIRB authorization process. However, the consent form that researchers provide HSD with the authorization request ("WIRB Cover Sheet") must incorporate CRBB's recommendations and requirements. In other words, the HSD and CRBB process continue to be mostly sequential rather than in parallel - though in a different order that should result in a somewhat faster process overall.
    • UW/WIRB Consent Template. The non-Clinical Pharmacology Unit (CPU) and CPU templates have been combined. The new template has been significantly revised to include much less required language and to allow more flexibility.
    • HIPAA Authorization Forms. Researchers no longer need to submit their HIPAA Authorization form to HSD or WIRB.
    • Relationship between UW Confidentiality Agreement and WIRB approval. Researchers no longer need to wait for WIRB approval before submitting the Confidentiality Agreement to HSD for approval. In other words, these formerly sequential processes can now occur in parallel.

    For complete details about these major changes see:

    HSD is grateful to our colleagues at CRBB and OSP for their willingness to help improve these parts of the clinical trial start-up process.


    HSD Closed on July 1st

    The HSD office will be closed on Wednesday, July 1st. Beginning on that day, HSD staff will be reorganized into new and larger teams. The office closure will allow us to complete the necessary physical moving of work spaces and files as well as other transition activities.

    The following activities and resources will remain open and staffed:

    • The HSD front desk on the 17th floor of the UW Tower
    • The main HSD phone line: 206.543.0098
    • The HSD help email address: hsdinfo@uw.edu (monitored only for urgent items)
    • Emergencies and urgent situation will continue to be handled but should be directed to the main HSD phone line or help email address rather than specific HSD staff.

    Slower Turnaround Times in July and August

    Especially for Minimal Risk and Exempt reviews

    As noted above, on July 1st, HSD staff are reorganizing into new and larger teams. The combination of internal promotions, new hires, and revised roles and responsibilities means that almost everyone in HSD will be doing some unfamiliar work in July and August.

    Intensive hands-on training is being provided now and through the rest of the summer. In addition we are implementing a modest increase in our work capacity during this time. We nonetheless expect that turnaround times will be significantly slower in July and August while we adapt to our new organizational structure and processes. After this transition, we expect turnaround times to return to previous levels or better, and to start reaping the benefits of increased consistency, better tracking of items, and more flexibility in handling workload fluctuations.

    We appreciate your patience. We will work hard to make the transition as smooth as possible. In the meantime, here are some suggestions for how you can help minimize the impact on your work:

    • Be sure to let us know if any IRB reviews you need during this time are truly urgent. Attach a memo on top of your application materials, or send an email to your staff contact or to hsdinfo@uw.edu
    • Keep in mind that applications and materials submitted during the first two weeks of July are likely to be most affected by this transition.

    Newborn Dried Bloodspots

    Significant new federal requirement: obtain parental consent

    On March 16, 2015, the Newborn Screening Saves Lives Reauthorization Act of 2014 went into effect. The Act reauthorized funding to improve and expand state-based programs that screen newborns for treatable, serious genetic disorders, educate providers and parents about newborn screening, and develop screening standards and surveillance efforts.

    The Act adds two new requirements that will have a significant impact on research with newborn dried blood spots (NDBS):

    1. The Act defines research with de-identified NDBS as being "human subjects research". This means that it must undergo IRB review. Previously, de-identified NDBS research was not considered "human subjects research" and therefore did not require IRB review.
    2. The Act eliminates an IRB's ability to waive the requirement to obtain informed consent for the use of the NDBS. This means that parental consent must be obtained in order to use NDBS. Practically speaking, this means that consent must be obtained at the time the newborn sample is taken, and it must be consent for future, unspecified uses.

    Applicability of these new requirements. These new requirements apply only to research activities that:

    • Meet the federal definition of "research"; and
    • Are funded by the federal Department of Health and Human Services (HHS); and
    • Use NDBS collected on or after March 16, 2015.

    Questions? Contact Karen Moe at kemoe@uw.edu or 206.543.7246


    Zipline

    Monthly Update

    HSD is embarking on a year-long suite of projects to replace our paper process with an electronic system. This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    Delta: More Experts, More Expertise

    As we roll ever closer to July 1st, this project is nearing completion. To prepare our office for the upcoming implementation of Zipline, we determined that our old staffing model of 13 small teams, each doing specialized review and determination work, would not mesh well with the workflow of the new electronic system.

    HSD's structure has not been reorganized since the office opened its doors in the early 1970's. Zipline proved to be the opportune time to both realign the organizational structure, and to create an environment that expands and draws upon HSD staff as the regulatory experts.

    The 13 small teams are being consolidated in to five teams. Each team will be lead by a new Team Operations Lead (TOL). The TOLs have been hired, the new teams formed, and we're ready to start operating with our new structure on July 1st!

    Other accomplishments for this project:

    • HSD staff are participating in formal regulatory training to prepare for a new breadth and depth of review and determination work.
    • TOLs are meeting to help determine staff workflow and tasks, and create consistent business practices across the office.
    • UW departments are now assigned to specific teams, and files are being moved between teams.

    In between now and July 1st, we'll be in a bit of flux with our organization chart, contacts page and contact widget, so please bear with us in our transition. If you don't find your specific staff contact, please call our front desk at 206.543.0098, or email hsdinfo@uw.edu. The results will be worth the wait.

    Read more about the projects in our flyers, and catch up with past Zipline news on the dedicated Zipline News page.


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic WIRB Process Documents
    Document(s) UPDATED: REVIEW AUTHORIZATION UW CC-IRB; UW WIRB Review Process Diagram; REQUEST AUTHORIZATION UW WIRB; SOP WIRB Review HSD Procedures; SOP WIRB Review - Researcher Procedures; UW WIRB FAQs and Frequent Errors; TEMPLATE, Consent Form, UW-WIRB
    Description Updated process for researchers to obtain HSD authorization to send industry trials to WIRB.
    Expected impact High
    Related changes Updated glossary terms, Confidentiality Agreement documents: TEMPLATE Confidentiality Agreement; Confidentiality Agreement Guidance
    Link for more information See the news article or the documents linked above.
    Implementation date

    Document uploaded May 29, 2015

    Processes implemented June 1, 2015

  • For the Record - May 4, 2015

    May 5, 2015 at 9:12am

    HIPAA Authorization Forms No Longer Reviewed

    New Policy, SOP and Guidance
    Revised HIPAA Template

    A significant policy change. The UW IRB no longer requires researchers to include HIPAA authorization forms with their IRB application materials. This change is effective immediately, and it applies to existing studies as well as new studies. However, the following policy continues unchanged: Researchers who will obtain UW Medicine PHI must use the HIPAA Authorization Template that is maintained on the HSD website, or obtain prior approval from UW Medicine Compliance for using a different authorization form.

    HSD and UW Medicine Compliance have worked together over the past several months to assess and revise policies, procedures, and guidance about HIPAA and the use of Protected Health Information (PHI) for research. The goals of the project were to:

    1. Clarify the role of the IRB with respect to HIPAA and the research use of PHI;
    2. Eliminate unnecessary institutional requirements that are not required by federal or state law;
    3. Incorporate the changes to HIPAA regulations that were passed in the last two years;
    4. Provide useful guidance for researchers about specific aspects of HIPAA and research;
    5. Add some detailed instructions to the HIPAA Authorization Form template, for sections that researchers frequently found confusing.

    The project has successfully concluded its work with the above policy change as well as these changes:


    "Which IRB reviews for my department?"

    Final changes are coming

    The pending July 1st reorganization of HSD staff and the disbanding of IRB Committee K have created the opportunity for HSD to complete the final phase of ensuring that the same IRB and same HSD staff team review, screen, and consult for a given department - regardless of whether a research study is exempt, minimal risk, or requires full IRB committee review. This policy increases consistency of review and advice. It also makes it easier for researchers to know who to contact at HSD.

    In the past two years, HSD has made significant progress towards this goal. Now the final step is being taken. All departments have been assigned to a single IRB and team. Beginning in mid-May:

    • New studies will be assigned to IRBs and Minimal Risk teams based on the new department distribution.
    • Existing studies that are not with the IRB/team serving the researcher's department will be transferred. For example, all studies from the Department of Surgery will be transferred to IRB Committee A (if they are not already being reviewed by IRB A).

    The new distribution list will be posted on the HSD website in mid-May. By July 1st the old minimal risk department look-up tool will be re-purposed for all teams. Researchers and study contacts for transferred studies will be informed by email of:

    • The effective date of the transfer
    • The IRB/team that will review the study in the future
    • The names and contact information for the HSD staff on that team

    We recognize that transferring studies can feel disruptive and create the need to develop new relationships with HSD staff. However, the long term benefits of consolidating all of a department's research with one IRB and one staff team should far outweigh this disruption.


    A Short Survey May Be Coming Your Way

    Early May

    A mandatory verification survey from the HSD post-approval monitoring program will be emailed in early May to all researchers with an active study that was reviewed by a full IRB committee. The email will contain a link to the survey, which will be administered through the secure REDCap system. It should take no more than two minutes to complete. Questions? Contact Jason Malone, HSD Assistant Director for Regulatory Affairs, at jmmalone@uw.edu or 206-543-2254.


    Research Involving Valley Medical Center

    NEW Guidance

    In consultation with UW Medicine and Valley Medical Center, HSD has created GUIDANCE: Research at Valley Medical Center. It provides clarification and details about IRB review for research involving Valley Medical Center. UW researchers are strongly encouraged to read it before submitting an IRB application that proposes to use Valley patients, records, or specimens.


    DOHR (Delayed Onset Human Research) Renewals

    Reminder about revised policy

    Most researchers who obtained a DOHR determination in the past year will NOT need to renew the determination because:

    • They have already obtained IRB approval for the research or,
    • The funding agency does not explicitly require (in writing or email) a DOHR determination for continuation of the funding.

    Per a revised HSD-OSP policy released in February 2015, DOHR determinations are made only when both of the following conditions apply:

    • It isn't possible to obtain IRB approval or exempt status at the beginning of the funding award for the reasons outlined in the SOP Delayed Onset Human Research, and
    • The funding agency explicitly requires a formal determination that it is not yet possible for the research to obtain IRB approval or exempt status. In the absence of this sponsor requirement, OSP requires only a simple assurance from the award's Principal Investigator (PI) in order to release the award.

    The revised policy applies to award continuations as well as initial awards.


    WIRB Process Changes

    In-Person Information Sessions

    Significant improvements to the WIRB authorization process will be implemented on June 1. Please join our Clinical Trials Administrator, Brecken Cardinal, for an information session about the new process. One session will be recorded and posted to our website for those who are unable to attend.

    Place Time Date
    Health Sciences, Room T663 10:30 to 11:30am Wednesday, May 20
    Seattle Cancer Care Alliance, Room 1006/1008 1:00 to 2:00 pm Wednesday, May 20
    Harborview, R&T 113 2:00 to 3:00 pm Wednesday, June 3

    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic HIPAA Authorization Forms
    Document(s) UPDATED: SOP HIPAA; TEMPLATE: HIPAA Authorization; TEMPLATE: HIPAA Authorization, Pregnant Partner; NEW: GUIDANCE: HIPAA
    Description Updated policy on the submission and review of HIPAA Authorization Forms. HSD no longer needs to receive them.
    Expected impact High
    Related changes All SOPs, APPLICATIONS, (too numerous to list here) and web pages have been updated to reflect this change. Contact hsdforms@uw.edu if you would like a full list.
    Link for more information See the news article or the documents linked above.
    Implementation date

    April 24, 2015

  • For the Record EXTRA - April 15, 2015

    Apr 15, 2015 at 2:42pm

    IRB Committee K

    Dis-continuation

    IRB Committee K will be discontinued after its April 29th meeting. This is due to the consistent shift in the pattern of our work observed in the past two years:

    • A significant reduction in the submissions that require full IRB review, accompanied by,
    • A dramatic increase in "minimal risk" and exempt applications.

    Rationale. HSD has known about this shifting pattern for a while, which is what led us to dis-continue IRB Committee C a year ago and to hire new minimal risk reviewers. Recent detailed analyses of our workload patterns were conducted in preparation for our pending staff re-organization. They revealed that this pattern is far stronger than we realized.

    Why K? Our data showed that K has the lightest incoming workload of the IRBs, and the smallest overall portfolio of studies. Therefore, its dis-continuation will have the least disruptive impact on researchers, the other IRBs, and HSD. The change involves no layoffs, demotions, pay cuts, or work reductions for HSD staff.

    Transition. Several transition activities are underway:

    • Department assignments. Departments assigned to IRB K for full IRB review and Subcommittee EK for minimal risk review will be assigned to other IRBs. This information will be posted and announced within the next month.
    • Existing studies. Existing studies will be transferred to the oversight of another IRB or IRB Subcommittee. HSD staff will inform researchers about these transfers as soon as possible.
    • Researchers. No action is required from researchers. Also, there are no changes in how IRB applications should be prepared and submitted.

    Impact on researchers. This change will increase our capacity for minimal risk and exempt reviews. There will be no decrease in our ability to meet the demand for full IRB review.

    We are deeply appreciative of the time, careful thought, and integrity that the IRB K members brought to this very important process for protecting participants in UW research. These are volunteer positions that require significant commitment. Thank you so very much, on behalf of the Office of Research and the University!


    Applicability of FDA Regulations

    Revised Criteria and New Guidance

    This change will have a very significant positive impact on research involving the use of drugs or devices, because it significantly decreases the number of studies to which the Food and Drug Administration (FDA) human subjects regulations will be applied. In addition, the documents describing this change should resolve long-standing confusion about this issue.

    The fundamental issue at the heart of this revision is whether a study meets the FDA's definition of human subjects research. HSD's revised criteria about this question are based on (1) recent HSD communication with the FDA and (2) careful consideration of recommendations by the federal Secretary's Advisory Council on Human Research Protections (SACHRP).

    The revised criteria are embedded in section 6 of the WORKSHEET: Human Subjects Research. Researchers may refer to this WORKSHEET to decide whether their research meets the FDA's definition of human subjects research. HSD has also released a new GUIDANCE: Applicability of FDA Regulations to provide additional context and details. The existing WORKSHEETS about the FDA's IND requirement and IDE requirement are unaffected by this change.

    This change has resulted in some minor but important changes to the following documents:


    "Public" Data Sets

    NEW Guidance; Revised SOP

    These changes will assist researchers who obtain data from large national datasets.

    For several years, HSD has maintained a list of large national datasets whose research use does not require UW IRB review or an exempt determination. Until now, these were labelled "public" data sets. This is inaccurate; the trait that the data sets all have in common is that their use does not meet the federal definition of "human subjects" because the data are (1) publicly available, OR (2) de-identified when provided to the UW researcher.

    The former SOP Public Data Sets has been replaced by a renamed and refreshed SOP Data Sets Not Requiring HSD or IRB Review with much shorter content, focused on procedures. Guidance and explanatory information has been moved to, and expanded for, the new GUIDANCE: Data Sets Not Requiring HSD or IRB Review. The Guidance document contains the list of the data sets.

    HSD encourages researchers to nominate additional datasets for this list, by following the instructions provided in the SOP.


    HSD is Hiring!

    Due to internal promotions and retirements, HSD has several positions open:

    • Req. #118734: IRB Administrator (4-5 positions)
    • Req. #118480: Compliance Administrator (2 positions)
    • Req. #118281: Review Coordinator (1 position)

    The position descriptions are posted on the UW jobs website, where applications from interested individuals should be submitted. Contact Jason Malone (jmmalone@uw.edu) for information about the Compliance Administrator positions. Contact Emily Guthrie (ehguth@uw.edu) or Maria Savage (mcsavage@uw.edu) for information about the other type of positions.

  • For the Record - April 6, 2015

    Apr 7, 2015 at 9:08am

    Records Retention Change

    Effective immediately

    The Washington State retention period for human subjects research records has been changed from 30 years after the close of the study to six years after the close of the study. The change applies to new, active, and already-closed studies.

    • This will have a significantly positive effect on budgets, space, and administrative oversight for researchers and their departments.
    • FDA, industry, and funding sponsor retention requirements continue unchanged, as applicable to specific studies.

    The websites of UW Records Management and UW Medicine Records Management have been updated to reflect this major change.


    HSD Office Organizational Changes

    Monthly Update

    HSD is embarking on a year-long suite of projects to replace our paper process with an electronic system. This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    HSD has completed initial steps towards the planned office re-organization ("Project Delta") described in previous editions of this newsletter. HSD is proud that this reorganization involves no layoffs, no pay cuts, no demotions, and no reductions in work time while adopting a simplified staffing structure that will make us more agile in response to changes, and will allow us to better serve the needs of the UW research community. The number of review-related staff will increase somewhat. This is the first reorganization of the office in over two decades.

    The most significant change combines minimal risk and full board teams, resulting in one larger team per IRB. We expect these changes to result in: staff with greater breadth and depth of expertise; improved consistency across teams and IRBs; and far less movement of IRB applications between HSD teams.

    The steps accomplished so far include:

    • Hiring for the new role in our office: Team Leads who will head up each of the new teams
    • Identifying the expected date (early June) when the new teams will be identified and can be communicated to campus
    • Establishing July 1 as the date when the new teams will begin operations

    Our review system is based on pairing each academic department with a specific IRB team and minimal risk team. There will necessarily be some changes to these pairing as our present 13 teams are being combined into one team per IRB. Re-assignments will also reflect our continuing efforts to achieve an equitable distribution of workload across the teams and the IRBs. We know that many researchers develop effective and close relationships with specific HSD staff, so we are trying to minimize the number of these changes. We will identify the specific changes in the coming issues of this newsletter.

    Read more about the projects in our flyer linked here.

    You can also catch up with past Zipline news on the dedicated Compass Project Portfolio site.


    New Assistant Director

    Jason Malone joined HSD on March 23rd as the Assistant Director for Regulatory Affairs (ADRA). Many of you already know Jason from his nine-plus years at the UW's Institute for Translational Health Sciences (ITHS), where he was the Clinical Compliance Officer. At ITHS, he was involved in almost every aspect of human subjects research compliance, including post-approval monitoring, research participant feedback, policy and procedure development, and coordinating with regional IRBs and other research compliance offices. Prior to joining ITHS, Jason was at Quorum IRB for six years. He was responsible at various times for overseeing Quorum's nationwide site monitoring program, IRB Administration, Regulatory Compliance, and Customer Relations. Jason has a Master's degree in Public Administration, and a Certificate in Global Health. In short, Jason brings a great breadth of education, experience and skills to this position.

    Maria Savage, who was the previous ADRA has become one of our two Assistant Directors for Operations - filling the vacancy left by Shannon Sewards. Maria is thrilled to be back in an operations role, which she previously held at the UC Berkeley IRB for several years before coming to the UW IRB almost two years ago.


    Federal Research Support

    New Guidance

    A new GUIDANCE: Federal Support document is now available. It describes the types of federal support (direct, indirect, and federal engagement) and gives examples. The presence or absence of federal support is one fundamental factor in determining:

    • Which human subjects regulations apply to a study
    • Whether many of the UW IRB flexibility policies (such as a 3-year approval period) can be applied to a study

    Some minor changes to the funding section of each application form have also been made, to assist in the identification of federal support.


    Pregnant Partner HIPAA Authorization Template

    Effective Immediately

    In collaboration with UW Medicine's Privacy Office, HSD has created a special HIPAA Authorization template, for use with pregnant partners of research subjects. This is in response to researcher request. About half of UW industry clinical trials need an authorization form for this purpose. This new template eliminates the researcher work required to customize the main authorization template for each new study.


    New and Revised Documents

    NOTE: Due to numerous updates, as of June 1, 2015, HSD will no longer accept forms listed below that are dated prior to 03/27/2015.

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Federal Research Support
    Document(s) NEW: GUIDANCE: Federal Support 
    Description New guidance to clarify what is meant by Federal Research Support.
    Expected impact Medium
    Related changes UPDATED: APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee; APPLICATION: Repository; APPLICATION: Determination, Exempt Status (PDF and Word); APPLICATION: Specimen or Data Use, Identifiable (PDF and Word); APPLICATION: Specimen or Data Use, Non-Identifiable; APPLICATION: Modification, Approved Project; APPLICATION: Continuing Review (Status Report) Renew or Close
    Link for more information See the news article or the documents linked above.
    Implementation date

    March 27, 2015

     
    Topic HIPAA Template
    Document(s) NEW: TEMPLATE: HIPAA Authorization, Pregnant Partner
    Description Special HIPAA Authorization template to be used with pregnant partners of research subjects.
    Expected impact Medium
    Related changes None
    Link for more information See the news article or the document linked above.
    Implementation date

    March 27, 2015

  • For the Record EXTRA - March 5, 2015

    Mar 9, 2015 at 11:59am

    WIRB Process Changes

    Information Sessions Cancelled

    Due to unforeseen circumstances, changes to the WIRB process will be delayed. All information sessions are cancelled, and will be rescheduled sometime in the coming months. We apologize for any inconvenience.

  • For the Record - March 2, 2015

    Mar 3, 2015 at 9:04am

    Human Subjects Assistance Program (HSAP)

    Revision implemented on March 1, 2015

    The Human Subjects Assistance Program has been revised as of March 1, 2015: It is now a discretionary program, with no "promise to pay" in advance for the treatment of research-related adverse effects for any subjects. Extensive outreach, as well as a month-long public review and comment period, did not reveal any significant problems or concerns with this proposed revision. The process by which researchers or subjects can request HSAP write-off and reimbursement of treatment expenses is clarified in this new revision. Also, the required consent template language has been simplified.

    See document updates below for a complete list of documents that have been updated


    WIRB Process Changes

    In-Person Information Sessions CANCELLED


    Evaluation of a Policy Change: Fewer Modifications

    As regular readers of this e-newsletter know, HSD is continually looking for ways to reduce work for researchers, IRB members, and HSD staff without negatively affecting subject protections and compliance. Most of our projects include an evaluation component to assess the actual impact.

    Many modifications involve changing the members of a research team. Beginning in 2013, we changed our policy about which members of a research team need to be listed by name on an IRB application and on the consent form, with the expectation that this would reduce the number of modifications researchers need to prepare and submit.

    Our evaluation of this change showed that our prediction was correct. In the last half of 2014, the number of modifications involving a change of research personnel dropped by 54%, from about 600 modifications of this type per year in 2013 to about 320 per year in 2014.


    Semi-Annual Metrics Report

    Posted February 27, 2015

    A new edition of the HSD Performance Metrics Report has been published and posted to the HSD website. It describes the workload and turnaround times for steps and sequences of the IRB review process for the period 7/1/14 through 12/31/14.


    Zipline

    Monthly Update

    HSD is embarking on a year-long suite of projects to replace our paper process with an electronic system. This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    This month's spotlight is on the Compass Portfolio project named Streamline. Streamline: "sensible simplification" of our forms and processes intends to prepare our office for integration with the new eIRB system, Zipline.

    These changes will harmonize our internal business process with Zipline and simplify the application process for researchers. Streamline project staff are working to reduce the number of application forms and regulatory decisions that researchers must navigate.

    Major Streamline Goals:

    • Only one or two initial application forms
    • Reduced number of supplement forms
    • Researchers will be required to make fewer regulatory decisions within the application
    • Researchers will not need to determine the risk level of the study
    • Revision of our business process to simplify the application process

    For example, instead of asking researchers to choose the level of review their project should receive by selecting the appropriate corresponding form, we will rely on staff expertise to evaluate incoming research plans and to direct applications to the appropriate level of review.

    Forms and process changes will be ready for testing along with Zipline in autumn quarter of 2015. The final changes will be implemented with Zipline in the first quarter of 2016! Contact HSD at hsdinfo@uw.edu with any questions.

    Read more about the projects in our flyer linked here.

    You can also catch up with past Zipline news on the dedicated Compass Project Portfolio site.


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Human Subjects Assistance Program (HSAP)
    Document(s) UPDATED: TEMPLATE: Consent Form, Standard; Human Subjects Assistance Program; HSAP Information Sheet
    Description Updated documents to reflect the change to a discretionary program.
    Expected impact High
    Related changes HSD website landing page also updated.
    Link for more information See the news article or the documents linked above.
    Implementation date

    Posted February 27, 2015

    Implemented March 1, 2015

  • For the Record EXTRA - February 17, DOHR and HSAP

    Feb 17, 2015 at 1:59pm

    Delayed Onset Human Research (DOHR)

    Revised UW policy and requirement

    Implementation Date: February 17, 2015

    The term Delayed Onset Human Research (DOHR) refers to funded research for which it isn't possible to obtain IRB approval or exempt status at the beginning of the funding award because:

    • Initial development work without human subjects is necessary.
    • The award will provide funding for projects or trainees that will be selected and funded by the awardee.
    • The award is for a clinical research network or consortium that will create protocols over the course of the award.

    What to do. The requirement to obtain a formal DOHR determination from HSD in order to release funds will be replaced as of February 17th with a simple assurance from the award's Principal Investigator (PI) that his/her human subjects work qualifies as "delayed onset human research" and that funds will not be spent on human subjects activities until IRB approval or exempt status has been obtained. OSP is integrating this assurance requirement into its processes for advance budget number eligibility, Just-in-Time requirements, and time of award.

    Researchers should apply for a DOHR determination ONLY when it is explicitly required (in writing or email) from the research sponsor.

    This change applies to all types of awards for which the UW previously required a formal DOHR determination, including: individual investigator awards; training grants; career development awards; program and center grants.

    Impact on researchers. One less form to complete, one less requirement for the release of new research funds, and (therefore) faster access to the funds.

    APPLICATION: Determination, Delayed Onset Human Research

    SOP Delayed Onset Human Research


    Human Subjects Assistance Program (HSAP)

    Revision to be implemented on March 1, 2015

    The Human Subjects Assistance Program will be revised on March 1, 2015: It will become a discretionary program, with no "promise to pay" in advance for the treatment of research-related adverse effects for any subjects. Extensive outreach, as well as a month-long public review and comment period, did not reveal any significant problems or concerns with this proposed revision. The process by which researchers or subjects can request HSAP write-off and reimbursement of treatment expenses is clarified in this new revision. Also, the required consent template language has been simplified.

  • For the Record - February 2, 2015

    Feb 2, 2015 at 1:42pm

    Delayed Onset Human Research (DOHR)

    Revised UW policy and requirement

    Implementation Date: February 17, 2015

    The term Delayed Onset Human Research (DOHR) refers to funded research for which it isn't possible to obtain IRB approval or exempt status at the beginning of the funding award because:

    • Initial development work without human subjects is necessary.
    • The award will provide funding for projects or trainees that will be selected and funded by the awardee.
    • The award is for a clinical research network or consortium that will create protocols over the course of the award.

    What to do. The requirement to obtain a formal DOHR determination from HSD in order to release funds will be replaced as of February 17th with a simple assurance from the award's Principal Investigator (PI) that his/her human subjects work qualifies as "delayed onset human research" and that funds will not be spent on human subjects activities until IRB approval or exempt status has been obtained. OSP is integrating this assurance requirement into its processes for advance budget number eligibility, Just-in-Time requirements, and time of award.

    Researchers should apply for a DOHR determination ONLY when it is explicitly required (in writing or email) from the research sponsor.

    This change applies to all types of awards for which the UW previously required a formal DOHR determination, including: individual investigator awards; training grants; career development awards; program and center grants.

    Impact on researchers. One less form to complete, one less requirement for the release of new research funds, and (therefore) faster access to the funds.


    Consent Template Changes

    Implemented January 30, 2015

    Big change. The lengthy and complicated Medical Records Information section of the standard UW consent template has been replaced by a single sentence added to the Confidentiality section. Almost all of the information in the section was (1) redundant with HIPAA authorization forms or (2) of little value to individuals making a decision about whether to participate in the research.

    Small change. The wording of the Financial Conflict of Interest section has been slightly revised, for clarification purposes.

    Impact on researchers

    • New consent forms: will be shorter, by as much as one full page. This should improve readability and comprehension.
    • Existing approved consent forms: No changes are required, though researchers are welcome to make these changes, if they wish. The changes do not require re-consenting of already-enrolled participants.


    HSD Roadshow Recording

    This January, Karen Moe, Director of the Human Subjects Division, delivered presentations to the UW research community from Bothell all the way to Tacoma. For those of you who were unable to attend, we recorded and posted one of those sessions.

    Click here to go directly to the presentation, or visit through our home page by selecting Training from the left hand navigation, then HSD Training Videos.

    Many thanks to our hosts and attendees.



    Zipline

    Monthly Update

    HSD is embarking on a year-long suite of projects to replace our paper process with an electronic system. This section of the HSD newsletter is dedicated to keeping the UW research community informed of our progress.

    The end of January marks the signing of a Statement of Work between the Office of Research and our partners, Huron Consulting Group. This officially begins the process of establishing Huron's Click IRB 7.0 for the University of Washington (where it will be called Zipline).

     The excitement of phasing out a forty-plus-year-old paper process is a bit overshadowed by the work that HSD needs to complete before replacing that process with an electronic system. In last month's newsletter, in addition to announcing the estimated implementation date, we informed campus of our need to reorganize both office and document structure to better align with the electronic system, and to increase our nimbleness as research methods and regulations change at ever faster rates.

    This portfolio of projects is named "Compass". It includes:

    • Project "Delta: More Experts, More Expertise", promoting the value of HSD staff as regulatory experts.
    • Project "Streamline: Sensible Simplification" is about creating clear, concise forms and documents.
    • Project "Zipline: A Clear Path" is the end goal: an electronic system that eases the burden on the researcher and establishes the foundation for better integration of the IRB review process with other compliance functions.

     Read more about the projects in our flyer linked here.

    You can also catch up with past Zipline news on the dedicated Compass Project Portfolio site.


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Consent Template
    Document(s) UPDATED: TEMPLATE: Consent Form, Standard
    Description Removed bulk of information regarding medical records.
    Expected impact Moderate
    Related changes This information will also be removed from the WIRB consent template.
    Link for more information See the news article or the document linked above.
    Implementation date

    January 30, 2015

     
    Topic Assent Template
    Document(s) UPDATED: TEMPLATE: Assent Form
    Description Revised to be more generic, and adaptable to a variety of research procedures, and language levels.
    Expected impact Moderate
    Related changes None
    Link for more information See the document linked above.
    Implementation date

    January 30, 2015

     
    Topic Engagement
    Document(s) UPDATED: WORKSHEET: Engagement
    Description Updated instructions more exactly mirror federal guidance by clarifying how to interpret and apply the exceptions to engagement.
    Expected impact Moderate
    Related changes None
    Link for more information See the document linked above, and the Engagement topic page on our website.
    Implementation date

    January 30, 2015

     
    Topic Vulnerable Populations
    Document(s) UPDATED: SUPPLEMENT: Protected and/or Vulnerable Populations
    Description Added an option for obtaining consent from illiterate populations to harmonize with the HSD Standard Operating Procedure on Consent Documentation.
    Expected impact Moderate
    Related changes None
    Link for more information See the document linked above, and the SOP on Consent Documentation
    Implementation date

    January 30, 2015

     

    Quick Tips from HSD

    Quick Tips is taking a time-out to attempt to break a Zipline test site. Soon, you can too! Send an email to Heather Rieck (hrieck@uw.edu), the Business Systems Analyst for Zipline, if you'd like to join in the fun sometime this fall.

  • For the Record - January 5, 2015

    Jan 5, 2015 at 2:54pm

    2015 HSD Road Show

    This winter, Human Subjects Division (HSD) Director Karen Moe will once again be making presentations to the UW research community regarding changes coming to HSD policies and procedures. These presentations will include information about:

    • eIRB
    • Longer IRB approval periods
    • Human Subjects Assistance Program
    • Marijuana research
    • and More!

    The sessions will take place at the times and locations listed below. One session will be recorded and uploaded to our website for those who are unable to attend.

    Place Time Date
    South Lake Union, Orin Smith Auditorium 10:30 am to Noon Monday, Jan. 12
    Harborview Medical Center, R&T Auditorium 1:00 to 2:30 pm Tuesday, Jan. 13
    Kane Hall, Walker Ames Room 1:00 to 2:30 pm Wednesday, Jan. 14
    UW Bothell Campus, Discovery Hall, Rm. 464 10:30 am to Noon Thursday, Jan. 15
    UW Tacoma Campus, Research Commons, Tioga Library Building, 307b
    12:30 to 2:00 pm 
    Thursday, Jan. 22
    Health Sciences, Turner Auditorium
    2:30 to 4:00 pm Friday, Jan. 23
     


    eIRB System: Zipline

    Monthly Update

    Implementation date. The Office of Research and HSD are pleased to announce that we expect to begin deploying the new electronic IRB application system ("Zipline") in the first quarter of 2016. We expect to begin widespread beta testing and training in autumn quarter. Watch this eNewsletter and HSD's website for monthly updates about the system status, specific deployment details, and opportunities for you to participate in pre-deployment training and testing.

    Related changes. The decision to switch from a paper-based application system to an electronic system created the need and opportunity for a series of related and coordinated changes that will also occur during the next fourteen months.

    1. Forms and processes, Some changes will be required in order to integrate with Zipline. We will also simplify the application process for researchers, primarily by reducing the number of forms and supplements. We will no longer require researchers to make preliminary regulatory decisions - for example, whether an initial application qualifies for "Minimal Risk" review or must instead go to the full convened IRB. These changes will generally be implemented at the same time as Zipline.
    2. HSD staff re-organization. The HSD staff will be re-organized by combining the Full Board and Minimal Risk teams together. The current 13 small teams will become 6 larger teams, each associated with one of the IRBs, and a new supervisory structure will be established. The re-organization is expected to occur in August, 2015, after lengthy internal preparations and training. This will be the first significant re-organization of HSD in over 25 years. We expect these changes to result in more agile, flexible, and consistent operations; staff with greater breadth and depth of expertise; and reduced integration and training time for new staff. Departments will still be assigned to specific teams, but there will necessarily be some changes in which departments are assigned to which teams. The department-team assignments will be made and publicized this summer.


    NSF Awards and Human Subjects

    NSF Policy Change

    Effective December 26, 2014

    Summary. The UW's Delayed Onset Human Research (DOHR) mechanism used to release funds from federal agencies for certain types of awards will no longer be accepted by the National Science Foundation (NSF).

    Details. For some awards, human subjects activities will not occur (and cannot be described in sufficient detail) until after the completion of preliminary or conceptual work that does not involve human subjects. Until now, the DOHR mechanism has been used in place of IRB approval to initially release funds for these types of awards. However, NSF will no longer recognize the DOHR status. This means that PIs on NSF awards of this type no longer need to apply to HSD for DOHR status. Instead, when they receive the Notice of Award, they should contact the relevant NSF Program Officer to establish any human subjects-related restrictions that would apply until the PI is ready to prepare an IRB application. PIs should continue to involve and inform the UW Office of Sponsored Programs (OSP) in these situations so that OSP is aware of (and can help implement) any NSF conditions.



    Human Subjects Assistance Program

    Draft revision available for comment

    The Human Subjects Assistance Program (HSAP) is being revised in order to address faculty concerns about the September 1, 2014, revision. The first revision limited the "promise to pay" in the consent form to healthy subjects. With this new revision, the HSAP will no longer promise to pay for the treatment of research-related adverse effects for any subjects. In short, the HSAP will become a discretionary program. The process by which researchers and or subjects can request HSAP reimbursement of treatment expenses is clarified in this new revision. Also, the required consent template language has been simplified.

    The draft revision is available on our website for viewing and comment through January 23, 2015. Send comments or questions to Karen Moe, HSD Director, at kemoe@uw.edu.


    Regional Recruitment Website

    Now accepting studies

    The UW School of Medicine and the Institute for Translational Health Sciences (ITHS) have created a website called Research Participant Link. Clinical research studies often end without answering important questions because of a lack of participating volunteers. To make it easier to find and participate in the research process, ITHS and the School of Medicine have built this website to connect members of the community to research study teams. Click on the link above to find out how to list your study.


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Delayed Onset Human Research (DOHR)
    Document(s) UPDATED: SOP Delayed Onset Human Research; APPLICATION: Determination, Delayed Onset Human Research
    Description Documents related to DOHR have been updated to note that NSF no longer recognizes this status.
    Expected impact Moderate
    Related changes HSD's DOHR webpage.
    Link for more information See the news article or the documents linked above.
    Implementation date

    December 26, 2014


  • HSD 2015 Winter Road Show

    Dec 11, 2014 at 11:58am
    HSD continues to make enhancements to policies and procedures in order to improve the experience of IRB review for the UW research community. Over the next few months, we will be embarking on several large projects that will have a positive impact for researchers. In January, HSD Director Karen Moe will be hosting informational sessions to ensure that the UW research community has an opportunity to learn about these projects and other upcoming changes. Please join us for one of the below sessions. You do not need to register. Presentations will include information about:
    • eIRB
    • Longer IRB approval periods
    • Human Subjects Assistance Program
    • Marijuana research
    • and More!

    The sessions will take place at the times and locations listed below. More information about where to find recordings for those who can't attend, will be coming soon.

    Place Time Date
    South Lake Union, Orin Smith Auditorium 10:30 am to Noon Monday, Jan. 12
    Harborview Medical Center, R&T Auditorium 1:00 to 2:30 pm Tuesday, Jan. 13
    Kane Hall, Walker Ames Room 1:00 to 2:30 pm Wednesday, Jan. 14
    UW Bothell Campus, **ROOM CHANGE** UW2 - Rm 327 10:30 am to Noon Thursday, Jan. 15
    UW Tacoma Campus, Research Commons, Tioga Library Building, 307b 12:30 to 2:00 pm Thursday, Jan. 22
    Health Sciences, Turner Auditorium 2:30 to 4:00 pm Friday, Jan. 23
  • For the Record - December 2, 2014

    Dec 5, 2014 at 1:10pm

    Longer IRB Approval Periods

    New Policy

    As part of the ongoing Flexibility Initiative, the UW IRB will now routinely grant IRB approval periods of three years rather than one year to most studies that meet these criteria:

    • Minimal Risk
    • Not federally supported
    • Not regulated by the Food and Drug Administration
    • UW IRB is not providing the IRB review for another institution's involvement in the study

    Details: The IRB retains its authority to grant shorter approval periods, when appropriate. Researchers are responsible for immediately informing the IRB if a study no longer meets the criteria for the 3-year approval period. This responsibility and the complete list of eligibility criteria will be outlined in a memo attached to the approval packet sent to researchers. In addition, researchers will continue to receive annual email reminders, which will be tailored to 1-year versus 3-year approval periods. The Flexibility Policy provides complete details, and describes other policies in our ongoing Flexibility Initiative.

    Impact: We estimate that about 60% of minimal risk studies will qualify for this new policy. Status Reports will be required just once every three years instead of every year.


    2015 HSD Road Show Rescheduled!

    This winter, Human Subjects Division (HSD) Director Karen Moe will once again be making presentations to the UW research community regarding changes coming to HSD policies and procedures. These presentations will include information about:

    • eIRB
    • Longer IRB approval periods
    • Human Subjects Assistance Program
    • Marijuana research
    • and More!

    The sessions will take place at the times and locations listed below. More information about what to expect, as well as where to find recordings for those who can't attend, will be coming soon.

    Place Time Date
    South Lake Union, Orin Smith Auditorium 10:30 am to Noon Monday, Jan. 12
    Harborview Medical Center, R&T Auditorium 1:00 to 2:30 pm Tuesday, Jan. 13
    Kane Hall, Walker Ames Room 1:00 to 2:30 pm Wednesday, Jan. 14
    UW Bothell Campus, Discovery Hall, Rm. 464 10:30 am to Noon Thursday, Jan. 15
    UW Tacoma Campus, Research Commons, Tioga Library Building, 307b
    12:30 to 2:00 pm Thursday, Jan. 22
    Health Sciences, Turner Auditorium 2:30 to 4:00 pm Friday, Jan. 23
     


    HSD's Electronic IRB Application System: Zipline

    Progress Report

    HSD is pleased to announce that a long-awaited electronic application system is on its way. Huron's Click IRB 7.0 product was chosen as the most suitable to the needs of UW researchers, IRB members, and HSD staff. A well-tested and widely used IRB document management system, Click is used by academic IRBs across the country.

    We have named the system "Zipline". The phased rollout of Zipline to campus will begin in the first quarter of 2016.

    This will be an early success for the University-wide Research Roadmap Initiative. The long-term goal of the initiative is to provide a single web portal for researchers from which they can manage all activities related to conducting research. In the short-term, the initial steps toward the Research Portal include (but are not limited to) building tools and processes to replace antiquated systems and reduce the administrative burden for researchers.

    Keep an eye on your inbox for monthly email announcements, as well as notices about in-person presentations and training sessions. It's going to be an exciting year!



    Human Subjects Assistance Program

    Notice

    The Human Subjects Assistance Program (HSAP) is being revised again, based on researcher feedback. This program provides some financial assistance to some subjects who develop a medical problem that is likely caused by a UW study. Example: a drug side effect.

    The draft revision will be announced and posted for feedback later this month. Also, HSD will briefly review the revisions at the upcoming HSD campus-wide presentations in January; this will be another opportunity for feedback before the revision is completed and implemented.


    HSD Management Change

    Announcement

    Shannon Sewards (ssewards@uw.edu) is leaving her position as HSD’s Associate Director of Biomedical Operations at the end of December. Beginning in January, she will be the Director of the Arts & Sciences IRB office at Harvard University.

    We will greatly miss Shannon. Since joining HSD in early 2007, Shannon has shepherded numerous positive changes and hired many of our outstanding staff. Among her many accomplishments, she was responsible for developing the UW dbGaP certification process for submitting genetic data to the NIH data repository when NIH established that initially-confusing requirement. Consequently, we were one of the first IRBs in the country to have a robust process, which has received national accolades for its clarity and sensible nature.

    Please begin directing any new questions you might have asked Shannon to our help email address hsdinfo@uw.edu. This address is monitored throughout each workday and is the most efficient way to ensure that your questions are quickly directed to the most appropriate person.

    Finally, please join me in thanking Shannon for her excellent work during the past 8 years, and in wishing her well in her exciting new position!


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Longer IRB Approval Periods
    Document(s) UPDATED: Flexibility Policy
    Description HSD's Flexibility Policy has been updated to reflect the new policy of longer IRB approval period.
    Expected impact High
    Related changes All SOPs, Application Forms, and Web Pages have had their language updated to reflect the new policy.
    Link for more information See the news article or the document linked above.
    Implementation date

    December 1, 2014

  • For the Record - November 3, 2014

    Nov 7, 2014 at 12:22pm

    Flexibility Policy

    Posted October 31, 2014

    The UW has always chosen to apply the federal regulations to all human subjects research, whether or not the research is federally funded, with very few exceptions.

    The Flexibility Policy establishes the Human Subjects Division's intent to be more flexible about which specific federal regulations are applied to non-federally-funded research. Through the Flexibility Initiative which started in May 2014, HSD will be gradually eliminating or changing certain specific requirements for non-federally-funded research. This is allowed by the terms of the UW's Federalwide Assurance (FWA).

    The Flexibility Policy allows for greater flexibility in the oversight of research for which federal regulations might not be appropriate or optimal. It also reduces unnecessary administrative burdens upon researchers, IRB members, and HSD staff.

    Two Flexibility projects have already been completed, resulting in:

    1. Creation of a new category of exempt research, called Category 7.
    2. Relaxing of some requirements about prisoners and research (see Prisoner Research below).

    NOTE: Beginning December 1, the UW IRB plans to begin granting longer IRB approval periods (three years instead of one) to minimal risk research that is not federally supported. This brings the UW into alignment with several large peer institutions such as the University of Michigan and the University of California system, and with the recommendations of the IRB accreditation organization (AAHRPP). The next edition of this newsletter will have more details.



    Flexibility Initiative: Prisoner Research

    Implemented October 31, 2014

    The changes:

    1. "Incidental" prisoners. For research that is not federally supported, the UW IRBs now apply a "light" version of the federal requirements about subjects who become incarcerated after they have already enrolled in a study. This applies to studies that have not already been approved by the IRB for enrollment of prisoners.
    2. Exception to informed consent. Enrollment of prisoners is not allowed in more-than-minimal risk emergency medicine research that involves a special waiver ("exception") of informed consent. However, HSD sought and obtained clarification from federal regulators that continued involvement of prisoners who are inadvertently enrolled in such federally-funded research is allowed, if the prisoners provide informed consent for their continued participation.

    The SOP on Prisoners has full details.

    These changes are especially important for researchers who do:

    • Lengthy longitudinal studies where retention and follow-up of every subject is critical
    • Emergency medicine research

    Marijuana Research Guidance

    NEW October 1, 2014

    Washington State law was amended in 2012 to permit the use, sale, processing, and production of marijuana for recreational purposes in addition to medical uses. It is anticipated that there will be expanded interest in, and opportunity for, marijuana research.

    Vice Provost for Research Mary Lidstrom asked a task force of UW faculty, legal, and administrative experts to create a guidance document for the UW research community about the conditions under which marijuana research may be conducted. The guidance is posted on the Office of Research website at: http://www.washington.edu/research/.SITEPARTS/
    .documents/.or/Final_Guidance_Concerning_Marijuana_Research_100114.pdf

    For more information, email: research@uw.edu.


    Off The Record

    NEW HSD Blog

    HSD is launching a new blog, titled "Off the Record". The intention for this blog is to create a forum for discussion of ethical, regulatory, and the sometimes light-hearted issues surrounding research with human volunteers. (Is showing someone pictures of vegetables before answering a survey really "priming"?)

    This blog is run by a small group of HSD staff, and accepts posting submissions from all HSD staff, IRB members, and any researchers that might like to contribute. In order to comment, log in with your UW NetID in the lower right hand corner of the page. There are specific categories: opinion pieces ("It Depends..."); articles of interest; tips for submitting materials to the IRB; and biographical pieces highlighting the diverse and decidedly "non-bureaucratic" HSD staff and IRB members.

    As the title implies, all opinions expressed on the blog are expressly "Off the Record", meaning no opinion represents the policies or opinions of the Human Subjects Division, the Office of Research, or the University of Washington. See the About page for more detailed information on posting, and who to contact if you'd like to contribute.

    Along with the new blog, HSD is launching a new name and a new look for our monthly newsletter. "For the Record" is the formal companion to "Off the Record". Look to the newsletter for regulatory, policy, and procedural updates, and to "Off the Record" for discussions on these topics.

    Email questions to: hsdinfo@uw.edu

     


    Clinical Trial Recruitment Website

    NEW Site Launched to Support UW Researchers

    The Institute of Translational Health Sciences (ITHS) is launching a new website in October 2014 to support recruitment for clinical trials. This site, which was built in partnership with the Office of Research and Graduate Education in the University of Washington's School of Medicine, is intended to meet the needs of UW researchers who have been lacking this resource since a previous site was retired.

    The registration process for new clinical trials is free and takes less than 10 minutes. The process requires research staff to enter basic study information, study team contacts, IRB approval dates, enrollment projections, and basic demographics. Once a trial is approved to post, the research team can be contacted directly by potential participants who visit the recruitment site.

    Postings will be organized by condition and will be searchable in a variety of avenues that accommodate scientific and lay audiences. Links to research participation sites at the partner institutions will also be available.

    Administration of the site and its content will be conducted by the ITHS Regulatory Support and Compliance (RSC) program. They will review all requests to post to ensure compliance with federal and institutional requirements.

    For more information, please contact Becky Ostrem at 206-598-6477 or by email at bostrem@uw.edu.


    Web Browser Compatibility and CITI

    The CITI Program - provider of online training in the protection of human research subjects - will be adding several new features and usability enhancements to their website in the coming months. To make full use of these enhancements, and to do so securely, it is important to use a current browser version when accessing the CITI Program.

    CITI currently supports Chrome, Firefox, Internet Explorer and Safari. Please note that effective March 2015, CITI Program's website will block the use of Internet Explorer 7.


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Flexibility Initiative
    Document(s) NEW: Flexibility Policy
    Description A new document outlining HSD's Flexibility Policy has been posted. It will be updated as HSD adopts new flexibility initiatives.
    Expected impact Medium
    Related changes Exempt Category 7, Prisoners (see next item)
    Link for more information See the news article or the document linked above.
    Implementation date

    October 31, 2014

     

    Topic Prisoners
    Document(s) UPDATED: SOP Prisoners; SUPPLEMENT: Protected and/or Vulnerable Populations; WORKSHEET: Prisoners
    Description Updated all Prisoner related documents to reflect the implementation of the Flexibility Policy.
    Expected impact Medium
    Related changes Flexibility Policy
    Link for more information See the news article or the documents linked above.
    Implementation date

    October 31, 2014

  • eNews re:IRB Review, October 6, 2014

    Oct 10, 2014 at 10:25am

    Revision of the new HSAP consent form language

    Implemented October 1, 2014

    The Injury Compensation section of the standard Consent Form Template has been slightly revised, in response to questions about the September 1, 2014 version of the Human Subjects Assistance Program (HSAP).

    Specifically, the section for studies that are not eligible for the HSAP now includes the information that subjects can ask the researcher to submit a request to obtain coverage for the costs of an otherwise uncovered treatment expense that was incurred to treat a research-related injury.

    Also, we are asking researchers to let us know (through hsdinfo@uw.edu) if they identify an eligible individual who decides not to participate in a study because of the injury compensation issue.

    See last months' eNews announcement regarding the Human Subjects Assistance Program on the HSD website.



    2014 HSD Road Show - POSTPONED

    Due to shifting project timelines, the HSD Road Show will be postponed until early 2015. We regret any inconveniences this may cause.

    Please look for future announcements regarding rescheduling.


    Checklists to Worksheets

    Ever wondered about the elements of consent? Maybe you want to know why it's difficult to do research with prisoners. Check out the latest updated tools from HSD!

    HSD has converted the majority of its old regulatory checklists into worksheets. The purpose of these worksheets is twofold: a guide for IRB members and staff for making regulatory decisions; and an informational tool for researchers and research coordinators to see into the complex regulatory world of the IRB.

    These worksheets can be found listed with their fellow SOPs (Standard Operating Procedures) on the Policies Procedures and Guidance Page, or on the forms page under "WORKSHEET".


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic WIRB Consent Forms
    Document(s) UPDATED: TEMPLATE: Consent Form, UW/WIRB; TEMPLATE: Consent Form, UW/WIRB Clinical Pharmacology Unit (CPU)
    Description Removal of two items that may be placed in subjects’ medical record: 1.) Expected start and end dates for your time in the study, and 2.) Whether there are healthy volunteers in the study.
    Expected impact Low
    Related changes None
    Link for more information See the documents, linked above.
    Implementation date

    September 26, 2014

  • eNews re:IRB Review, September 8, 2014 - Human Subjects Assistance Program

    Sep 15, 2014 at 9:49am

    Revised Injury Compensation Program

    Implemented September 1, 2014

    For several decades the UW has had a no-fault program that provides free medical care at specific UW facilities and associated financial help to research subjects who have a medical problem that is most likely caused by UW research.

    The program has now been revised to (1) accommodate numerous changes in health care systems and (2) increase clarity and transparency about the program. The primary changes to the program are:

    • A $250,000 cap on the value of the free medical care
    • Restriction of the program to healthy volunteers*
    • A new name: the Human Subjects Assistance Program (HSAP)
    • Development of a HSAP Information Sheet to distribute to subjects, explaining the program
    • Revised language in the Compensation for Injury section of the UW standard consent template

    *A healthy volunteer is a subject whose inclusion in the research is not based on having a generally-recognized physical, mental, or emotional disorder or abnormality, and who does not have a known pre-existing disorder or abnormality that is relevant to the research.

    The previous version of the program will continue to be applied to already-approved studies, as described in their consent forms. See the HSD website for the program documents:


    The UW IRB as a Central IRB

    Important information for federal grant applications

    Central IRB: The use of a single IRB to provide IRB review for all of the study sites in a multi-site clinical trial, instead of obtaining IRB review from the IRB affiliated with each research site. This is also referred to as shared IRB review or a consolidated IRB.

    NIH is increasingly likely to require a central IRB as a condition of an award, because it increases efficiency, reduces overall trial start-up time, and decreases duplicative efforts that do not contribute to meaningful human subjects protection. HSD is almost always willing to allow UW researchers to rely upon a central IRB, through an authorization agreement.

    However, the UW IRB is not currently in a position to be able to serve as the central IRB for a group of institutions. This is due to the significant cost and staff-intensive nature of the central IRB role throughout the life of the study.

    It is important to carefully read the federal funding announcement (e.g. RFA or PA) to identify requirements related to IRB review. The requirement for a central IRB is usually stated in a single sentence. Here are examples taken from recent RFAs from several NIH institutes:

    • Applicants must propose a consolidated or centralized IRB approach for trial oversight.
    • Additional efficiencies will be encouraged through the use of master trial agreements and a central IRB.
    • NIDDK will give preference to Clinical Centers agreeing to use a central IRB of record.
    • Applicants are strongly encourage to consider models that will facilitate "shared review" such as IRBShare or a central IRB of record...Having a central IRB of record for multi-site trials is preferred.
    • Describe key features of a safety monitoring plan including plans for efficient IRB review and approval including the use of centralized IRB models when multiple clinical sites are planned.

    If you plan to apply as the PI for a multi-site award that requires or strongly encourages the use of a central IRB, please consult with the HSD Director as soon as possible for assistance with identifying how to fulfill this requirement and its impact on your proposed budget. Like any requirement for significant use of UW resources (e.g., space, computing infrastructure), this requirement needs attention and supporting documentation before submitting your application.


    Semi-annual Metrics Report

    Posted August 29, 2014

    A new edition of the HSD Performance Metrics Report has been published and posted to the HSD website. It describes the workload and turn-around times for steps and sequences of the IRB review process for the period 1/1/14 through 6/31/14. Highlights include the following median approval turn-around times:

    • Exempt applications: 5 business days. This is the lowest it has been since 2011, despite a 21% increase in Exempt applications compared to the same period last year.
    • Minimal Risk applications: 31 business days. This increase is expected to be a temporary situation caused by (1) transferring a large number of social/behavioral studies previously reviewed by a full IRB committee to the Minimal Risk team and (2) hiring and training four new Minimal Risk staff.
    • Full IRB applications: 59 business days. This is the same compared to the equivalent period last year.

    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Human Subjects Assistance Program (HSAP)
    Document(s) NEW Human Subjects Assistance Program; HSAP Information Sheet
    Description Detailed documentation of the revised HSAP; information sheet for subjects
    Expected impact Medium
    Related changes REVISED SOP Reporting by Researchers, update definition of "medical problem"; REVISED TEMPLATE: Consent Form, Standard, replaced research injury language; REVISED APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee, removed question F.3. regarding research injury
    Link for more information See article in this eNews, or documents, linked above.
    Implementation date

    Posted: August 29, 2014

    Implemented: September 1, 2014

     

    Topic Agreements: Authorization vs. Cooperative
    Document(s) REVISED APPLICATION: Modification, Approved Project; REVISED APPLICATION: Repository; REVISED APPLICATION: Specimen or Data Use, Identifiable (Word & PDF); REVISED SOP Authorization Agreements
    Description Clarifying with which entities HSD has an IRB Authorization Agreement, and between which entities it has a Cooperative Agreement.
    Expected impact Medium
    Related changes None
    Link for more information See documents, linked above.
    Implementation date August 29, 2014
  • 2014 HSD Road Show Postponed

    Sep 6, 2014 at 2:53pm

    Due to shifting project timelines, the HSD Road Show will be postponed until early 2015. We regret any inconveniences this may cause.

    Please look for future announcements regarding rescheduling.

  • eNews re: IRB Review - July 7, 2014

    Jul 11, 2014 at 9:34am

    A Table of Contents

    Implemented June 19, 2014

    "Wow!! This looks AWESOME! Very straightforward order and grouping. I love it!"

    HSD received this comment shortly after implementing the new organization and table of contents for our Policies, Procedures, and Guidance. The documents are now organized by topic and subtopic. In addition, links to relevant forms and worksheets are now co-located with the policies and procedures. This should make it significantly easier to find what you need. The alphabetical browse A-Z list and the search function remain available too.

     


    Flexibility Initiative: Part 2 of 12

    A year-long focus on regulatory flexibility

    Did you know that many institutions do not allow IRB office staff to be IRB members? There is no regulatory basis for this policy.

    We receive about four new Minimal Risk applications and three new Exempt applications for every one new application that requires full IRB committee review. HSD currently has 12 full time review staff who focus exclusively on doing Minimal Risk and Exempt reviews. Imagine how many additional faculty members would need to join our IRBs if our staff members weren't able to do these reviews! Also, consider the tremendous time pressures our faculty members already face to obtain funding, do research, teach, and (in many cases) treat patients at the UW clinics.

    A mental exercise: Twelve staff at 40 hours per week equals 480 hours. If each faculty IRB member contributed four hours per week to Minimal Risk and Exempt reviews, we would need an additional 120 IRB members to maintain our current turn-around times for review and approval.

    For well over a decade, the UW has allowed HSD staff to be members of the IRB, primarily for the purpose of doing Minimal Risk and Exempt reviews. To ensure high quality reviews, we hire well qualified staff and put them through a lengthy apprenticeship-style training program. Most of our Minimal Risk staff have advanced degrees and/or significant experience in the fields that they review. We believe this approach ensures the protection of human subjects in addition to protecting the time of our faculty members.

    Flexibility Initiative Part 1: A new category of exempt research.

     


     

    Status Report Improvement

    A time-consuming question has been removed.

    Question C.3. has been deleted from the APPLICATION: Continuing Review (Status Report), Renew or Close. The question required researchers to list all modifications, problem reports, and conditional approval responses submitted to the IRB in the past approval period (usually one year), including the HSD number assigned to the item and the date it was approved. The form is used at least once a year by every IRB-approved study.

    The question is not required by the regulations, nor does it provide information relevant to the criteria for IRB approval. It was added a few years ago with the intent of making it easier and faster for the IRB members to do the annual re-review of each study; however, it has not had any noticeable effect.

    Completing the list required significant time for most researchers. Also, confirming its accuracy has been a major source of "back and forth" between HSD staff and researchers which required additional time. Deleting this question is a "win" for everyone.

     


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Status Report
    Document(s) REVISED: APPLICATION: Continuing Review (Status Report), Renew or Close.
    Description Removal of question C.3. - the table asking for all modifications, problem reports, and conditional approval responses sent to HSD in the past year.
    Expected impact High
    Related changes None
    Link for more information See article in this eNews, or document, linked above.
    Implementation date June 30, 2014
  • eNews re: IRB Review - June 3, 2014 - Flexibility is Coming to HSD

    Jun 4, 2014 at 11:32am

    IRB Committee C: Farewell

    IRB Committee C held its last meeting on May 15th. It was one of the original UW IRBs, and has operated in one form or another since 1966, for 48 years!

    In the past two years, we've revised our procedures to make sure that social/behavioral research is reviewed by a full convened IRB committee only when the research does not qualify for exempt status or Minimal Risk review. This has been extraordinarily successful. The results:

    • Faster approval times for researchers;
    • Shorter IRB Meetings and less work for our IRB members.

    To accommodate this fundamental shift in work distribution, we've de-commissioned IRB Committee C, and started a new Minimal Risk team with the HSD staff from IRB C. All studies previously overseen by IRB Committee C are being transferred to a Minimal Risk team, or to one of the two remaining social/behavioral IRBs. Researchers will be contacted about the transfers as they occur. There will be no disruption or delays in the IRB review of new applications, Modifications, or Status Reports.

    Thank you to the many, many faculty members and HSD staff who served on or supported IRB Committee C!

     


    Flexibility Initiative: Introduction

    HSD is pleased to announce the launching of our Flexibility Initiative. Its purpose is to identify areas of flexibility in IRB review that can reduce workload for researchers and/or IRBs and that can be implemented without diminishing human subject protections.

    The flexibility projects we will implement during the next year have been identified as "best practices" by a national group called the Flexibility Coalition. The Flexibility Coalition is an informal grass-roots organization that consists of IRB managers that are interested in achieving a more flexible approach to the increasingly burdensome requirements for human subjects research. HSD is one of more than 75 members. The federal IRB oversight agencies and accrediting organizations agree with the Flexibility Coalition's approach and suggestions.

    We plan to adopt some highly visible changes that will dramatically affect minimal risk research that is not federally funded. The first Flexibility Project is now complete and was implemented on May 30 (see news item below). Stay tuned for additional Flexibility news, as a regular feature of this newsletter!

     


     

    Flexibility Project: Exempt Category 7

    Implemented: May 30, 2014

    HSD's first Flexibility Project is the implementation of a new category of Exempt research, called Category 7. The qualifications are the same as for Category 2 Exempt status, except that Category 7:

    • Allows the use of tasks, games, priming, and physical actions by a subject, and
    • It is limited to research that is not federally supported.

    HSD believes that a significant number of studies will now qualify for Exempt status rather than requiring an IRB application and Minimal Risk review. See the SOP Exempt Determination (Section 8) for more information. The advantages of Exempt research include:

    • Faster review
    • No annual Status Reports and renewals
    • Review of Modifications is not required except in limited circumstances

    We will publish metrics about the impact of this first Flexibility Project later in the year. An exciting fact: less than 24 hours after this change, we have already received and approved the first Category 7 Exempt application!

     


     

    Past Their Pull Date

    Please make sure that you are using the latest version of the APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee. There have been many improvements: the addition of a Genetics Supplement; revision of the Engagement section; removal of the drug and device sections in favor of new Supplements.

    HSD will no longer accept older versions of this form as of August 1, 2014.

    As always, please don't use forms that you've saved to your computer to begin a new application. Go to our website, and download the latest version. We are always trying to improve.

    HINT: If you want to know what has changed on any document, scroll down to see the "Change Notes" on the website landing page.

     


    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Exempt Determination
    Document(s) REVISED: SOP Exempt Determination; APPLICATION: Determination, Exempt Status (Word and PDF)
    Description SOP and forms revised to include new Exempt Category 7.
    Expected impact High
    Related changes None
    Link for more information See article in this eNews, or documents themselves, linked above.
    Implementation date May 30, 2014

     

  • eNews re: IRB Review - May 1, 2014

    May 5, 2014 at 2:00pm

    Additional Minimal Risk Staff

    Minimal risk and exempt reviews have been the largest and fastest growing part of HSD's work for the last few years. There has been a significant concurrent decrease in applications requiring review by a full convened social/behavioral IRB. HSD believes that this represents a fundamental and permanent shift in our work that will continue to grow.

    HSD was previously unable to increase Minimal Risk staff to keep pace with this change. Consequently, Minimal Risk approval turnaround times have increased. We are now happy to announce some long-awaited relief for our dedicated and over-worked Minimal Risk staff. Within three months, we will have:

    • Three new Minimal Risk administrators
    • One new Minimal Risk review coordinator

    This is being accomplished by re-distributing staff and vacant positions within HSD. One of the social/behavioral IRBs will be discontinued as of June 30, and the staff associated with that IRB will joining Minimal Risk teams.

    Next month's e-Newsletter will have more information about theses changes. We expect the transition to be smooth and to require no extra work for those researchers whose studies will eventually be transferred from the discontinued IRB to another social/behavioral IRB.

     


    WIRB-Related Documents and Tools

    HSD previously announced the availability of two significantly revised Standard Operating Procedure (SOP) documents that consolidated the dozens of previous, outdated documents about sending industry trials to Western IRB (WIRB) for IRB review.

    Brecken Cardinal, HSD's Clinical Trials Administrator, has now completed revising or developing the suite of documents and tools about using WIRB for IRB review. Note the inclusion of two new items below. We hope that this suite of documents will greatly assist study coordinators and their principal investigators.

    The completed suite includes:

    SOP WIRB Review - Research Procedures Implemented 2/28/14
    SOP WIRB Review - HSD Procedures Implemented 2/28/14
    UW/WIRB FAQs and Frequent Errors NEW 3/28/14
    UW WIRB Initial Submission High Level Process Diagram Revision 2/28/14
    UW/WIRB Initial Submission Detail Level Process Diagram NEW 3/28/14
    REQUEST AUTHORIZATION: UW/WIRB Revision 2/28/14
    TEMPLATE: Consent Form, UW/WIRB Revision 4/25/14
    TEMPLATE: Consent Form, UW/WIRB Clinical Pharmacology Unit (CPU) Revision 4/25/14
    WIRB Fee Schedule 2014 Revision 2/14/14
    WIRB Clinical Pharmacology Unit Fee Schedule Revision 5/10/13
    WIRB Clinical Pharmacology Unit Services Brochure Revision 5/10/13

     

    Feel free to contact Brecken with questions or comments, through hsdinfo@uw.edu or 206-543-0639. She is also available to meet with you or your research group, at your facility, to review the WIRB process and how to make it as efficient as possible for your group. Thank you, Brecken!

     


     

    Research with Native Populations

    Respect for Persons, Beneficence, and Justice. These are the three ethical principles of the Belmont Report: the document that underlies today's federal regulations on research with human subjects. The Belmont Principles address the rights, risks, and benefits for individual subjects but they have been criticized for paying little attention to the rights, risks, and benefits for groups of subjects. This is most likely to be an issue for research that involves distinct and identifiable groups in specific locations, such as Native populations.

    Though federal human subjects regulations do not require it, the UW IRB believes that it is important to consider group rights, risks, and benefits of research with Native populations. The National Congress of American Indians (NCAI) Policy Research Center has published a Research Regulation Toolkit - a comprehensive set of tools and resources intended to support tribal leaders and their communities in regulating research. These tools also provide thoughtful insights for researchers working with tribal communities.

    The toolkit includes documents on policy and practice considerations, a guide to reviewing research studies and an excellent guide on Community-Based Participatory Research in American Indian and Alaska Native Communities.

     

  • eNews re: IRB Review - April 1, 2014

    Apr 4, 2014 at 8:14am

    Open HSD Position: Post Approval Monitor

    Now Hiring

    Wendy Brown, HSD's Post Approval Monitor, has retired and is currently basking in the Arizona sunshine, watching the Mariners spring training. Wendy provided many years of valuable service to the UW: at HSD, the Clinical Research Center, through the Seattle Cancer Care Alliance, and as a member of IRB Committee A. Thank you, Wendy!

    If you are interested in the position, you can apply through the UW employment site, under requisition #105919 "Post Approval Monitor". Clinical research coordinators are likely to have significant relevant experience and background for this position.

     


    Federal Certificate of Confidentiality

    Reminder About Timing

    Certificates of confidentiality are issued by federal agencies for research involving sensitive data, upon request by the researcher. They allow researchers to refuse to fulfill requests or subpoenas for identifiable sensitive research data.

    If a Certificate is planned or required for a study, be sure to allow sufficient time for obtaining the Certificate from the federal agency before you begin contacting subjects. IRB approval cannot be granted for the parts of the study that will be covered by the Certificate until the UW IRB has received and acknowledged the Certificate from the researcher. This includes recruiting and consenting for those parts of the study. See the SOP Certificate of Confidentiality for more information.

     


    Clinical Trials Registration at CT.gov

    Reminder About How to Obtain Help

    Most clinical trials are required by federal law to be registered at the public website www.ClinicalTrials.gov (sometimes referred to as "CT dot gov"). This is the responsibility of the researcher, except for industry trials and trials reviewed by the Fred Hutchinson IRB.

    Richard Brzustowicz, a senior HSD administrator, is the University's primary administrator for CT.gov. He can help you with setting up accounts, re-setting passwords, and similar issues. Email him at brz@uw.edu or call him at 206-543-4464. Also, short step-by-step instruction documents are available at the HSD Clinical Trials.gov web page, where you can also find contact information for the federal staff who can help you with questions or difficulties as you navigate specific registration requirements.

     


    Required HIPAA Training for Washington State IRB

    New Option for Fulfilling this Requirement

    The Washington State IRB reviews UW research that will use records or clients from certain state agencies such as the Washington State Department of Health. When the state records include Protected Health Information (PHI), the state IRB requires all members of the research team to obtain training about the federal HIPAA regulations that govern the use of PHI.

    UW faculty, staff, or students who are not employees of UW Medicine cannot take UW Medicine's HIPAA training. Therefore HSD has arranged for two alternative ways to fulfill this requirement:

    • Completion of the standard CITI human subjects training (which includes HIPAA) through the CITI web portal, or
    • Completion of the stand-alone HIPAA module (titled "Health Information Privacy and Security (HIPS)") through the CITI web portal.

    CITI is a national online human subjects training service. You must enter and register through the UW portal. Instructions are located on the HSD website.

     


    2014 Update to the International Compilation of Human Research Standards

    The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines that govern human subjects research in 107 countries, as well as the standards from a number of international and regional organizations. The Compilation was developed for use by researchers, IRBs, and others.

    The 2014 edition is now available and can be accessed in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html. Major changes in human subjects standards were reported for Brazil, France, Kyrgyzstan, Switzerland, Taiwan, and Turkey. Three new countries are featured in the 2014 edition: Cameroon, Mozambique, and Zambia.

     


    Continuing Medical Education (CME) Credits for the NIH PHRS Course

    Physicians who successfully complete the free online NIH course in the Protection of Human Research Subjects (PHRS) can earn up to 3 American Medical Association Physician's Recognition Award (AMA PRA) Category 1 Credits TM.

    The CME Credit option is offered through a partnership with University Health Services - Professional Education Program of Virginia Commonwealth University Health System. CME-eligible individuals who want to earn these credits must follow the link to VCU's registration system after completing the training and pay a $25 fee for CME credit recording.

    For more detailed information, visit the NIH PHRS training page, and click on the link to CME info. HSD has also posted information on our training pages.

     


    HSD On YouTube

    HSD now has its own YouTube channel. We are producing short (3-7 minute), focused video presentations about the IRB review of Human Subjects Research. The videos are available from the left hand navigation menu on the HSD website homepage. Click on "Training" then "HSD Training Videos", or use this direct link.

    The latest video focuses on the changes to compliance and problem reporting by researchers. It outlines the new standard operating procedures regarding what does and what does not need to be reported to the IRB.

    Also available on this page, a recording of  live HSD Information Sessions, videos regarding changes to the Modification Form, and a video summary of policy changes made over the last year.

    Please send any questions or comments to Katy Sharrock, Training and Education Specialist, sharrock@uw.edu.

     


     

    New Email Address for Reminders

    HSD is now using a new email address to send the automatic reminders for Status Reports (continuing review). The new email address is uwhsdcrr@uw.edu. Please add this email address to your "safe list" to prevent reminders from ending up in your junk email box.

    As a reminder, it is ultimately the researcher's responsibility to track IRB approval periods and ensure that IRB approval does not lapse. Failure to receive or notice HSD reminders does not absolve researchers of this responsibility, nor does it change the consequence of a lapsed approval. For more information, see SOP Status Report Reminders.

     


  • eNews re: IRB Review - March 4, 2014

    Mar 5, 2014 at 3:18pm

    Reporting Research Problems to the IRB

    NEW procedure, NEW form, NEW policy

    Implemented 2/28/14

    The procedures used by researchers for reporting problems to the IRB have been significantly changed. "Problems" includes, for example: unanticipated problems, certain types of adverse events, non-compliance, data breaches, subject complaints, laptop thefts, etc.

    Instructions. The new document SOP Reporting by Researchers now provides complete information about:

    • What needs to be reported (and just as important, what doesn't need to be reported)
    • When to report it
    • How to report it
    • What happens after something has been reported.

    Policy change. The reporting procedures include a major policy change: researchers are no longer required to report minor non-compliance to the IRB except in very limited circumstances. "Minor non-compliance" is defined in the document. This policy decision is consistent with federal regulations. It is based on an extensive analysis of non-compliance reported to the UW IRB in the past year.

    Forms. There were previously three different forms for reporting; each for a different purpose. These have now been consolidated into a single new PDF form called the REPORT: Problems form. There are still some situations that should be reported by using the APPLICATION: Modification, Approved Project form. A table in the SOP Researcher Reporting Requirements clearly describes which of the two forms to use for which types of situations.

    Send reports by email. Instead of using campus mail or in-person delivery, the REPORT: Problems is sent to the IRB by email, using the address hsdinfo@uw.edu

    Management of reported problems. A new document SOP Management of Research Related Problems describes the HSD and IRB procedures for managing problems reported by researchers.

    Benefits. The primary purpose of these changes is to improve compliance with federal regulations. The changes also reduce the number of reports required, and make it easier and faster to report problems.

     


    Emergency or Compassionate Use

    NEW procedure, NEW form, NEW policy

    Implemented 2/28/14

    Physicians who wish to use an investigational drug, device, or biologic for clinical treatment of a single patient must comply with specific Food and Drug Administration (FDA) requirements and UW medicine policies.

    Changes

    The procedures to ensure compliance with these requirements have been significantly revised and improved.

    • IRB concurrence not required: it is no longer necessary to obtain the concurrence of an IRB chair or to inform the Human Subjects Division (HSD) before the emergency or compassionate use.
    • Complete detailed instructions are now provided in a single document for each type of use.
    • A required template consent form is now available.
    • Single easy-to-find location: The instructions and the template are located together on a single HSD webpage. Single Patient Emergency Use ButtonClick on the big red button labeled "Single Patient Emergency Use" on the HSD home page.

    Benefits

    • The instructions guide physicians through every step, including UW Medicine requirements.
    • All requirements and documents are together, in an easy-to-find location.
    • The process is now simpler and faster.
    • The required template consent form is:
      • Easy and fast to complete;
      • Compliant with all FDA requirements;
      • As short and as simple as possible, to improve patient comprehension.

     


    Genetics Supplement

    NEW application form supplement

    Implemented 2/28/14

    A new application supplement is now available. Its purpose is to provide genetics-specific information necessary for IRB review and approval. In the past, this information was obtained through "back and forth" correspondence. HSD expects that receiving this specialized information at the same time as other information will eliminate some "back and forth" and speed up the review process. Also, it will be easier for the IRB to ensure that appropriate subject protections are provided in genetics research.

    The new supplement should be attached to:

    • Any new (initial) application that involves genetics research.
    • Any Modification that proposed new or revised genetics-related procedures for an already-approved study.

     


    Clarity about CLIA Lab Certification

    NEW information

    Implemented 2/28/14

    Federal regulations (called CLIA) require certification of any facility (including research labs) that performs tests on "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings". The HSD website has a new document called SOP Lab Certification (CLIA) that describes the federal requirement.

    Researchers are responsible for deciding whether their laboratories require certification. The Human Subjects Division and the IRB do not play any role in the interpretation, implementation, or enforcement of CLIA requirements at the UW except to inform researchers about the requirements and how to fulfill them.

    IRB approval is not conditional upon obtaining CLIA certification, even when CLIA certification is appropriate. However, the IRB carefully considers all aspects of a researcher's plan to return specific research laboratory results to individual research subjects before granting IRB approval for the plan. This includes consideration of the two issues underlying the CLIA regulations:

    1. Information about the validity and reliability of the laboratory test.
    2. Information about the procedures for ensuring that the correct results will be returned to the correct individuals.

     


    Performance Metrics

    A new edition of HSD Performance Metrics has been published to the HSD webpage. It describes the turnaround times for steps and sequences of the IRB review process for the period 7/1/13 through 12/31/13.

     


    WIRB News

    Western IRB (WIRB) reviews most UW industry-sponsored-and-initiated research, on behalf of the UW IRB. Before researchers send their IRB applications to WIRB, they must first obtain an institutional assessment and authorization from the Human Subjects Division (HSD).

    NEW Procedure. A new document SOP WIRB Review - Researcher Procedures is now available to help researchers and study teams obtain the required HSD assessment and authorization. It replaces more than a dozen previous documents that each described one component of the process. The new document:

    • Consolidates all previous documents
    • Describes current procedures, which have been significantly revised and simplified in the past year
    • Is organized according to the sequence that the researcher and study team should follow, so it can be used as a checklist

    A similar document: SOP WIRB Review - HSD Procedures describes the internal procedures that HSD follows for the assessment and authorization.

    REVISED WIRB fees. The WIRB review fees are usually charged directly to the industry sponsor. WIRB's Fee Schedule was revised on January 1, 2014, and is posted to the HSD website.

    NEW Metrics. The HSD assessment and WIRB's IRB review are part of the industry clinical trial start-up process. HSD has recently developed the ability to measure the turnaround time for the HSD and WIRB components of this process. These metrics are now included in HSD's semi-annual metrics report. They provide useful information for researchers to consider when planning and navigating the start-up process. They are reproduced here:

    Industry Clinical Trials: Turnaround Times1 for Specific Start-up Processes

    From

    To

    Median
    (Business Days)

    Range
    (Business Days)

    HSD receipt of researcher’s materials

    HSD initial screening response

    0

    0 to 12

    HSD receipt of researcher’s materials

    Completion of HSD screening

    232

    0 to 125

    Completion of HSD screening

    IRB application submitted to WIRB

    33

    0 to 42

    Application received by WIRB

    WIRB approval granted

    84

    0 to 67

    1 These turnaround times are based on about 60 WIRB-reviewed studies that were approved by WIRB in the six months 7/1/13 through 12/31/13.

    2 This step requires information from other offices before HSD can complete its screening and institutional sign-off for WIRB. It includes the time required for: HSD's screening activities; sponsor response time and edits to consent forms and other documents; completion of contract negotiations by the Office of Sponsored Programs (OSP); and completion of the study budget by the Clinical Research Budget and Billing (CRBB) Office.

    3 This step is performed by the study team and/or study sponsor.

    4 This step represents the turnaround time for WIRB review.

     


    IRBshare: A Central IRB Model Ready to Use!

    The Human Subjects Division (HSD) has teamed up with the Institute of Translational Health Sciences (ITHS) to bring you IRBshare. IRBshare is NOW fully ready for your use.

    What is IRBshare?

    IRBshare is a centralized, electronic joint IRB review model for federally-funded multi-site studies that accelerates the review process by enabling a temporary reliance between member IRBs for initial review while maintaining UW IRB oversight for all subsequent aspects of a study (such as Status Reports and Modifications).

    What are the benefits of IRBshare to researchers?

    The expected advantage for researchers is that there will be quicker turnaround times and fewer clarifications or contingencies requested by the UW IRB.

    How do I obtain more information or submit a study?

    • Check the IRBshare website for available studies. Available studies may be identified here - http://irbshare.org/#studies
    • See the procedure SOP IRBshare
    • Contact Shannon Sewards, Associate Director for Biomedical Operations (ssewards@uw.edu, 206-543-2254)
    • Or, check with your study coordinating center for more information

     



    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

    Topic Reporting Research Problems to the IRB
    Document(s) NEW: REPORT: Problems; SOP Reporting by ResearchersSOP Management of Research Related Problems 
    Description New SOPs and one single form for problem reporting. Clearer instructions regarding what does and does not need to be reported.
    Expected impact High
    Related changes Related SOPs altered.
    Link for more information See article in this eNews, or documents themselves, linked above.
    Implementation date February 28, 2014

     

    Topic Emergency or Compassionate Use
    Document(s) NEW: INSTRUCTIONS and NOTIFICATIONs: Compassionate Use, Device; Emergency Use, Device; Emergency Use, Drug or Biologic NEW: SOPs: Device Compassionate Use; Expanded Access; Single Patient Emergency Use; NEW: TEMPLATE: Consent Form, Emergency and Compassionate Use
    Description All new instructions and documents regarding how to use an investigational drug, device, or biologic for clinical treatment of a single patient.
    Expected impact High
    Related changes Red button added to home page.
    Link for more information See the documents linked above, or the article in this eNews.
    Implementation date February 28, 2014

     

    Topic Genetics Supplement
    Document(s) NEW: SUPPLEMENT: Genetic Research; SOP Lab Certification (CLIA) REVISED: APPLICATION: Human Subjects Review (13-11), Full Board or SubcommitteeAPPLICATION: RepositoryAPPLICATION: Specimen or Data Use, Identifiable
    Description A new supplement has been added for Genetics Research, along with a new SOP describing CLIA requirements.
    Expected impact High
    Related changes All initial applications have been updated to add pointers to the Genetic Supplement if needed.
    Link for more information See the article in this eNews, or the forms themselves, linked above.
    Implementation date February 28, 2014

     

    Topic WIRB
    Document(s) NEW: SOP WIRB Review - Researcher Procedures; SOP WIRB Review - HSD Procedures REMOVED: Old policy documents.
    Description Consolidates old policy documents.
    Expected impact Medium
    Related changes REQUEST AUTHORIZATION: UW/WIRB altered slightly to harmonize with new SOPs
    Link for more information See the article in this eNews, or documents themselves, linked above.
    Implementation date February 28, 2014

     

  • HSD Metrics: Report 19 (7/1/13 to 12/31/13)

    Feb 20, 2014 at 10:17am

    A new edition of HSD Performance Metrics Report has been published to the HSD website. It describes the turnaround times for steps and sequences of the IRB review process, for the period 7/1/13 through 12/31/13.  This edition includes new metrics measuring turnaround time for WIRB reviewed studies.

  • eNews re: IRB Review - February 4, 2014

    Feb 3, 2014 at 1:35pm

    ANNOUNCEMENT: Education Sessions

    The changes announced in this newsletter have a broad and significant impact. HSD is conducting several one-hour sessions on campus to describe the changes and answer questions about them.

    Currently scheduled sessions include:

    • UW Tower Auditorium: Wednesday, 2/12, 1:30 - 2:30 pm
    • Health Sciences Room K-069: Friday, 2/14, 2:00 - 3:00 pm
    • Harborview R&T Auditorium: Thursday, 2/20, 12:30 - 1:30 pm

    In addition, a four-minute video about the changes is available on the HSD Training Videos webpage.


    CHANGE: How new applications are assigned to an IRB

    Implementation: January 15, 2014

    Expected impact: See the list of advantages below

    Most new applications requiring full IRB review are now being assigned to a specific IRB based on the researcher's academic unit. For example, new biomedical research from the Department of Orthopaedics or from the School of Dentistry will now always be reviewed by IRB Committee D. Exceptions may occasionally be made due to IRB workload issues. In addition, research involving certain issues (emergency exception to consent; pregnant women) is now always being assigned to the same IRB. Academic units with lower volumes of human subjects applications will be assigned on a rotating basis to IRBs whose membership has the expertise to review the research. The significant advantages of this new policy:

    • Improved consistency of IRB reviews.
    • Improved quality of review (because departments are assigned to IRBs based on member expertise).
    • Increased opportunity to establish helpful and positive working relationships between researchers, HSD staff, and the IRB.
    • Departments will reap a direct benefit by having faculty members serve on the IRB that reviews the department's research.

    See the HSD website for a list of the academic units reviewed by each IRB. Existing approved studies will stay with their already assigned IRBs.


    NEW TOOL: Finding the right HSD staff person

    Implementation: January 1, 2014

    Expected impact: Quicker and more accurate process for obtaining answers to questions

    Specific IRB staff teams and Minimal Risk teams have now been assigned to each of the academic units that submit most of the IRB applications. Look up your HSD staff contacts by using these tools:

    Want to discuss a planned application or an application that is under review? Call or email the HSD staff contact identified for your academic unit. These are the same staff that will be involved in the review process. If your department/academic unit isn't listed, feel free to contact any staff listed for "general biomedical research" or "general social/behavioral research". Also, feel free to continue to use the frequently-monitored HSD help email: hsdinfo@uw.edu or to call our front desk at 206-543-0098


    CHANGE: Who is identified by name on IRB applications

    Implementation: January 31, 2014

    Expected impact: Significant reduction in "nuisance" modifications to change team members

    IRB applications no longer ask for the name of every member of your research team. Instead, applications ask for the names and contact information for only those individuals fulfilling the following specific roles for your research:

    • Lead Researcher: also called the principal investigator.
    • Faculty Advisor: required only when the lead researcher is a student.
    • IRB Contact Person: the person with whom the IRB should communicate.
    • Study Coordinator: the person who manages the day-to-day operations of the study.
    • Subject Contact Person: the person(s) to whom the participant questions, complaints, and adverse events should be directed

    For all other team members, application forms now ask for only the qualifications required for individuals whose roles include conducting procedures that involve risk to subjects. Example: for a study involving a behavioral therapy intervention for drug abuse, the application should describe the background/experience/ licensing requirements (but not names) for individuals who will deliver the behavioral therapy. Modification forms about a change in the research team will be required only when there are changes to named individuals or the qualifications for a role.


    CHANGE: Who is identified by name on consent forms

    Implementation: January 31, 2014

    Expected impact: Significant reduction in "nuisance" modifications to change team members

    Consent forms are now required to list only the lead researcher, the subject contact person, and (for student research) the faculty advisor. Modifications to consent forms because of a change in the research team will be required only when there is a change to the lead researcher, subject contact person or faculty advisor. Researchers are not required to modify existing approved consent forms. However, if a consent form is being modified for some other reason, it is in the researcher's best interests to also change who is listed on the document.


    CHANGE: Identification of involvement of other organizations and institutions

    Implementation: January 31, 2014

    Expected impact: Significant reduction of "back and forth", and significant reduction of non-compliance on this issue

    All application forms now have a short new section for this specific purpose which also provides guidance to researchers. On the Modification form, this new section replaces a previous section that was long, complicated, and confusing.


    CHANGE: Training verification

    Implementation: January 31, 2014

    Expected impact: Fewer attachments to IRB application; elimination of a major question on the IRB application; less "back and forth"

    Researchers are no longer required to provide documentation that training requirements have been fulfilled by research team members, when the training has been completed solely to fulfill the requirements of an external funding agency. A careful analysis showed that the IRB's role in verifying fulfillment of training requirements was redundant with the process followed by the federal funding agencies. Therefore, the IRB's requirement has been eliminated. Note that the IRB has the authority to require training even when it is not required by funding agencies; in these cases, the researcher should provide documentation of training completion.


    REVISION: Modification Form

    Implementation: January 31, 2014

    Expected impact: The form is easier to understand, navigate, and complete. Because it is a "smart" PDF form that displays only the information relevant to a specific study and modification, the printed copy will almost always be significantly shorter.

    The new Modification Form is finally here! It is now a "smart" PDF form. This change to the most frequently used IRB form allows users to select and see only the sections pertinent to the changes being made. It also implements the policy changes described above meaning fewer modifications forms to complete and submit for IRB approval. The new form also has a shorter and simpler section about the involvement of other organizations and institutions. Previous versions of the Modification will not be accepted after February 28. Be sure to replace any downloaded versions of the previous Modification form.

    HSD and the IRB expect researchers to begin using the revised forms immediately. We recognize that some applications may already be partially completed on the older forms. Researchers may complete the applications on those forms; HSD staff will contact you if they have any questions or need additional information because of these revisions.

  • More Positive Changes are Coming!

    Jan 23, 2014 at 12:44pm

    HSD is implementing policy changes that will impact who is listed on IRB applications and consent forms among others.

    In support of these changes, HSD is releasing a new smart-PDF Modification form that has an improved user interface and should be easier for researchers to complete. These policy changes are reflected in updated versions of other relevant forms as well (including initial applications).

    Starting the afternoon of January 31st, please download the new forms from our website for submission to our office.

    In order to ensure that the UW research community has an opportunity to learn about the policy changes along with changes to the Modification Form, HSD will be hosting information sessions around campus mid-February.

     

    Human Subjects Division Information Sessions:

    Day Time Location
    Wed., 2/12 1:30 pm UW Tower Auditorium
    Fri., 2/14 2 pm Health Sciences, Auditorium K069
    Thurs., 2/20 12:30pm Harborview MC, R&T Auditorium

    Please Send All Questions To: hsdinfo@uw.edu

  • eNews re: IRB Review - November 26, 2013

    Dec 4, 2013 at 10:18am

    New Questions on the Main IRB Application Form

    Implementation date: November 22, 2013

    In the past few months, some new questions have been added to the main IRB application form. The purpose of these questions is to provide the IRB with additional information that will help make the review process smoother and more efficient. The new questions include:

    • Section V. Type of New Submission. The purpose of this new section is to enable the assignment of new applications to a specific (consistent) IRB based on department/college/school and specific types of research, in place of the previous random assignment method.
    • Question IX.B.5. This section summarizes the required Supplements that may be needed for the application. It includes three new supplements, for research involving devices; drugs, botanicals, or biologics; or the Department of Justice.
    • Question IX.H.6. This question is used to identify research that is required to comply with federal regulations that apply to research on students or student records.
    • Question IX.H.11. This new question serves to remind researchers about a new requirement concerning billing subjects or subjects' health insurance for research related procedures.

     


     

    Clinical Trials Registration: Impact on Billing for Research Procedures

    Implementation date: January 1, 2014

    For the past several years, most clinical trials have been required to register with a national database called ClinicalTrials.gov (see http://clinicaltrials.gov). This includes investigator-initiated trials. A new federal requirement states that the clinical registration number must now be provided as part of the billing process, when research subjects or their health insurers are billed for the cost of research-related services, procedures, and facilities fees for most clinical trials. Question IX.H.11 has been added to the main IRB application form, to remind researchers about this new requirement.

    For more information about this new requirement, contact the UW Clinical Research Budget and Billing (CRBB) office:

    For more information about how to register a clinical trial:

     


     

    HSD Personnel News

    Shannon Sewards has been promoted from Assistant Director to Associate Director. In addition to recognizing her many important contributions to HSD and the IRB, this promotion acknowledges her role of taking on the responsibilities and authority of the Director when the Director is unavailable or out of the office.

    The HSD Compliance Team has been reconfigured and expanded to include additional regulatory responsibilities. It is now called the HSD Regulatory Team. The Regulatory Team consists of:

    • Assistant Director of Regulatory Affairs Maria Savage (mcsavage@uw.edu), who came to HSD in 2013 from the IRB at UC Berkeley.
    • Compliance Analyst Jean Kang (kangjj@uw.edu), who came to HSD in 2013 from the IRB at Pepperdine University.
    • Compliance Analyst Laurie Berger (lberger@uw.edu), who was previously an HSD Minimal Risk Administrator.

     


     

    IRBshare Reminder

    The Human Subjects Division (HSD) has teamed up with the Institute of Translational Health Sciences (ITHS) to bring you IRBshare: a centralized, electronic joint IRB review model for federally-funded multi-site studies that accelerates the review process by enabling a temporary reliance between member IRBs for initial review while maintaining UW IRB oversight for all subsequent aspects of a study (such as Status Reports and Modifications).

    For the first year, the UW will use IRBshare to rely on other institutions (rather than allowing others to rely on us). This means that at least one IRBshare member institution must have performed its IRB review and uploaded the review materials into the secure IRBshare server.

    See the HSD webpage on IRBshare or contact Shannon Sewards, Associate Director for Biomedical Operation (ssewards@uw.edu; 205-543-2254). Your study coordinating center may also have information.

     


     

    HSD Campus Presentation Recording Available

    For those that were unable to attend, and those that would like to review, a recording of one of the HSD campus presentations from earlier this month is now available on our website.

    Click here to view.


     

    Email Size Limits

    UW-IT has limited the size of email messages at the UW to 25 MB in preparation for an upcoming migration to "UW Exchange Online". If you need to email a document(s) to an HSD staff member that is larger than 25 MB, please compress the item, break up the item into multiple emails, or contact hsdinfo@uw.edu for assistance.

     


     

    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. Please see our newsletter online for a full description of the changes. We welcome feedback and suggestions. (hsdforms@uw.edu)

  • UPDATE: HSD Informational Session Recording Available

    Nov 18, 2013 at 8:00am

    Changes Coming to HSD!

    In order to better serve the UW research community, and to address the findings of two recent federal audits of the UW IRBs, HSD will be implementing numerous changes to our policies, procedures and forms over the next six months. All changes are being made to improve HSD's compliance with federal and state regulations and to improve the quality and consistency of IRB review at UW. Many of these changes will also reduce or streamline the IRB-related work required from researchers. Earlier this fall, HSD delivered several presentations to various locations on campus.

    A recording of one of the presentations is now available on our website on our new HSD Training Videos page.

    Changes discussed include:

    • What does, and does not, need IRB review
    • IRB issues for research involving other institutions
    • Translation and interpretation
    • Identifying FDA-regulated studies
    • More!

    Please Send All Questions To: hsdinfo@uw.edu

  • eNews re: IRB Review, November 5, 2013

    Nov 7, 2013 at 9:24am

    New Policies and Procedures

    On Friday, November 1st, a new group of Standard Operating Procedures (SOPs) and related tools were implemented and posted to the HSD website. The specific documents are listed below.

    They focus on:

    • FDA-Regulated research
    • Research involving specific federal agencies such as the Department of Justice and the Environmental Protection Agency.
    • Research involving prisoners, unviable neonates, or neonates of uncertain viability

    In addition to the SOPs, a CHECKLIST has been created for each topic and agency. These can be used by researchers to identify the relevant requirements when preparing an IRB application. This should reduce the amount of "back and forth" during review.

    The policies regarding prisoners and neonates have been revised to take advantage of regulatory flexibility. Specifically, this means that the Specifically, this means that the requirements about these vulnerable populations are applied only to federally-funded research and to non-federally-funded research with the types of risks and methodology that the requirements were designed to address.

     


     

    HSD Forms: A New Naming System

    HSD has implemented a new naming system for our forms, to make the names more consistent, and the forms easier to find on our website.

    The naming scheme will generally follow this formula: ACTION: Event, Audience. For example, the "Initial Application Use of Identifiable Biological Specimens/Data" has become: "APPLICATION: Specimen or Data Use, Identifiable". The Human Subjects Review Application: UW 13-11 is now: "APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee.

    The main keywords will remain in the title of the form, and the alphabetical forms list on our website is now much easier to scan and navigate.

    Send your questions or comments to Sherry Edwards, Information Manager at sherrye@uw.edu or 206-221-0994.

     


    A New HSD Service for WIRB Reviewed Studies

    HSD examines the consent forms for industry-sponsored clinical trials before giving permission for the trials to be reviewed by Western IRB (WIRB). This often involves negotiation with the industry sponsor or Contract Research Organization (CRO) about specific wording in the consent form and the HIPAA authorization form. The negotiation has always been conducted through the study research staff, who act as "go betweens".

    HSD is now offering to negotiate directly with the sponsor or CRO. This optional service is selected by the principal investigator of the study staff when completing the REQUEST AUTHORIZATION: UW/WIRB form.

    This will reduce the workload of study staff. It is likely to also reduce the time required for any negotiation, and therefore, the time required for this part of the study start-up process.

    Contact Brecken Cardinal (HSD Clinical Trials Administrator) with any questions, at hsdinfo@uw.edu, or 206-543-0639.

     


     

    Executive Order 24

    Executive (presidential) Order 24 is the University's highest level statement about its commitment to the ethical and compliant conduct of research with human participants. A significant revision was implemented on October 11, 2013, after broad feedback from faculty groups, other compliance offices, and IRB members.

    EO 24 provides a brief statement of principles, responsibilities, administration, and oversight.

    Read the executive order here.

     


     

    HSD on YouTube

    HSD now has its own YouTube channel. We are producing short (3-7 minutes), focused video presentations about the IRB review of human subjects research. The video are available from the left hand navigation menu on the HSD website homepage. Click on "Training" then "HSD Training Videos".

    These videos are an alternate way for researchers to obtain "on-demand" education and information. The first video focuses on the set of policy changes implemented this summer by HSD. More videos will follow focusing on the remaining policy changes implemented this year. We plan to post many additional short videos about specific topics, such as Translation & Interpretation, and Certificates of Confidentiality.

    We hope you enjoy this exciting new feature. Please send any questions or comments to Katy Sharrock, Training and Education Specialist, sharrock@uw.edu.

     


    Reminder IMPORTANT ANNOUNCEMENT

    Applicability of FDA Regulations

    SIGNIFICANT REVISION
    Effective October 25, 2013

    A revised UW policy, will cause the basic Food and Drug Administration (FDA) regulations to be applied to significantly more studies than in the past. These basic FDA regulations are 21 CFR 50 (informed consent requirements) and 21 CFR 56 (IRB review requirements). This will be in addition to the basic "Common Rule" federal regulation of 45 CFR 46, and any other applicable regulations.

    Why is this change occurring?

    The UW IRB is adopting a slightly different interpretation of the FDA's definition of "human subjects research", to bring the UW IRB into alignment with most other IRBs and with federal agency discussions. The primary change is for studies involving drugs. The FDA considers "any use of a drug outside of medical practice" that involves one or more human subjects to be FDA-regulated human subjects research. The following issues are irrelevant in determining the applicability of the FDA regulations:

    • Whether or not the drug is investigational or already approved by the FDA;
    • Whether or not the study is assessing the safety or efficacy of the drug;
    • Whether or not the study data will be submitted to the FDA;
    • Whether or not the purpose of the study is to support commercial development of the drug.

    Does this mean that more studies will need an IND or IDE?

    IND and IDE are the initials that refer to obtaining permission from the FDA to do research with an investigational drug or device. Being subject to FDA regulations does not necessarily mean that a study needs an IND or IDE.  HSD has released worksheets that guide researchers through the process of determining whether they need to apply to the FDA for an IND or IDE.

    What impact will this have?

    The basic FDA regulations are very similar to the basic federal human subjects regulations that are already applied by the UW IRB. This means that being governed by the basic FDA regulations does not have much impact on the study or how it is reviewed by the IRB. The most important differences are listed here. They are also described in a new procedure document called SOP FDA-Regulated Research.

    • A waiver of consent cannot be granted except for certain types of emergency medicine research. Note that the FDA does not consider it to be human subjects research when medical records are screened in order to identify potential study participants, so a waiver of consent can still be granted for this activity, under the other federal human subjects regulations.
    • The FDA requires a few additional elements in the consent form. These were already incorporated into HSD's standard consent form template within the past few years.
    • Serious non-compliance, unanticipated problems, and suspensions of IRB approval must be reported by the IRB to the FDA as well as to other agencies and the study sponsor.

    Is there a way to determine whether the FDA regulations apply to a study?

    HSD posted the WORKSHEET Human Subjects Research to its website at the end of June. Researchers, HSD staff, and the IRB can use this worksheet to determine whether the study meets the FDA's definition of human subjects research. If it does, then the basic FDA regulations apply. If the study is FDA-regulated, the researcher can then use the Worksheets about INDs and IDEs to determine whether an IND or IDE is needed.

    Will any other FDA related changes occur at the same time?

    Yes, HSD has now implemented:

    These new documents will provide the IRB with more initial information, thereby reducing the need for some back-and-forth correspondence. 

    Contact HSD through hsdinfo@uw.edu if you have any questions or concerns.

     


    New and Revised Documents

    Please see the list of new and revised documents in our online eNews. We welcome feedback and suggestions. (hsdforms@uw.edu)

  • Information Regarding Government Shutdown

    Oct 1, 2013 at 7:09am

    Dear Research Community,

    The partial shutdown of the federal government that began at midnight last night will have negative effects on some human subjects research. Thankfully, the impact will most likely be limited to some new studies that have not yet received IRB approval, where delays for a variety of reasons are possible. The table that has been posted to our website summarizes the information we have at present. It also includes suggestions for action and possible mitigation.

    HSD will provide new information and updates as we receive them. If you experience other negative impacts, we would appreciate knowing about them so we can explore mitigation avenues and share the information campus-wide.

    If you have any questions or concerns, contact:

     

    Karen Moe
    Director, Human Subjects Division
    206-543-7246
    kemoe@uw.edu or hsdinfo@uw.edu

  • eNews re: IRB Review, September 30, 2013

    Oct 1, 2013 at 7:01am

    IMPORTANT ANNOUNCEMENT

    Applicability of FDA Regulations

    SIGNIFICANT REVISION
    Effective October 25, 2013

    A revised UW policy, implemented at the end of next month, will cause the basic Food and Drug Administration (FDA) regulations to be applied to significantly more studies than in the past. These basic FDA regulations are 21 CFR 50 (informed consent requirements) and 21 CFR 56 (IRB review requirements). This will be in addition to the basic "Common Rule" federal regulation of 45 CFR 46, and any other applicable regulations, that are already being applied by the UW IRB.

    Why is this change occurring?

    The UW IRB is adopting a slightly different interpretation of the FDA's definition of "human subjects research", to bring the UW IRB into alignment with most other IRBs and with federal agency discussions. The primary change is for studies involving drugs. The FDA considers "any use of a drug outside of medical practice" that involves one or more human subjects to be FDA-regulated human subjects research. The following issues are irrelevant in determining the applicability of the FDA regulations:

    • Whether or not the drug is investigational or already approved by the FDA;
    • Whether or not the study is assessing the safety or efficacy of the drug;
    • Whether or not the study data will be submitted to the FDA;
    • Whether or not the purpose of the study is to support commercial development of the drug.

    Does this mean that more studies will need an IND or IDE?

    IND and IDE are the acronyms that refer to obtaining permission from the FDA to do research with an investigational drug or device. Being subject to FDA regulations does not necessarily mean that a study needs an IND or IDE. INDs and IDEs are a separate issue that is governed by other FDA regulations (21 CFR 312, for investigational drugs, 21 CFR 812, for investigational medical devices). The interpretation and application of these other regulations is not changing. However, HSD will be releasing worksheets at the end of October that guide researchers through the process of determining whether they need to apply to the FDA for an IND or IDE.

    What impact will this have?

    The basic FDA regulations are very similar to the basic federal human subjects regulations that are already applied by the UW IRB. This means that being governed by the basic FDA regulations does not have much impact on the study or how it is reviewed by the IRB. The most important differences are listed here. They are also described in a new procedures document called SOP FDA-Regulated Research that will be released on October 25, 2013.

    • A waiver of consent cannot be granted except for certain types of emergency medicine research. Note that the FDA does not consider it to be human subjects research when medical records are screened in order to identify potential study participants, so a waiver of consent can still be granted for this activity, under the other federal human subjects regulations.
    • The FDA requires a few additional elements in the consent form. These were already incorporated into HSD's standard consent form template within the past few years.
    • Serious non-compliance, unanticipated problems, and suspensions of IRB approval must be reported by the IRB to the FDA as well as to other agencies and the study sponsor.

    Is there a way to determine whether the FDA regulations apply to a study?

    HSD posted the WORKSHEET Human Subjects Research to its website at the end of June. Researchers, HSD staff, and the IRB can use this worksheet to determine whether the study meets the FDA's definition of human subjects research. If it does, then the basic FDA regulations apply. If the study is FDA-regulated, the researcher can then use the upcoming worksheets about INDs and IDEs to determine whether an IND or IDE is needed.

    Will any other FDA related changes occur at the same time?

    Yes, HSD will also be releasing on October 25, 2013:

    • A mandatory application supplement for Drugs, Biologics, Botanicals and Supplements, for any new IRB application involving such items.
    • An application supplement for Medical Devices, for any new IRB application involving medical devices.
    • Single Patient Emergency Use instructions, a form, and a significantly streamlined procedure.
    • Compassionate Use of Devices instructions and a form.
    • Humanitarian Use Device procedures and consent template.

    These new documents will provide the IRB with more initial information, thereby reducing the need for some back-and-forth correspondence. They will also provide clear, step-by-step instructions for UW physicians who want to use an investigational drug or device to treat a seriously ill patient when there are no other options.

    Contact HSD through hsdinfo@uw.edu if you have any questions or concerns.

     


     

    Subject Payment and Income Tax

    REVISION

    The HSD guidance document about income tax, Social Security numbers, and paying subjects for their participation in research has been significantly revised. Some of the information about specific income tax requirements was out-of-date or inaccurate. This includes the information about paying foreign nationals (i.e., non-U.S. citizens) for participation in domestic research.

    The guidance document now points the reader directly to the appropriate Financial Management websites, so that the reader can be assured of always having access to correct information. Questions about subject payment, income taxes, and Social Security should be directed to the Financial Management staff identified on those websites instead of HSD staff.

    See: Subject Payment Confidentiality and Income Tax See the Financial Management website for details.

     


     

    IRBshare: A New Central IRB Model

    What is IRBshare?

    IRBshare is a centralized, electronic joint IRB review model for federally-funded multi-site studies that accelerates the review process by enabling a temporary reliance between member IRBs for initial review while maintaining UW IRB oversight for all subsequent aspects of a study (such as Status Reports and Modifications).

    What are the benefits of IRBshare to researchers?

    The expected advantage for researchers is that there will be quicker turnaround times and fewer clarifications or contingencies requested by the UW IRB.

    How does IRBshare change my workload?

    Not much. IRBshare is primarily an internal tool for IRBs and their staff. Researchers are still required to:

    • Provide all initial IRB application materials to HSD, using UW forms.
    • Provide ongoing Status Reports.
    • Provide Modifications for UW approval.
    • Meet all local reporting requirements to the IRB/institution (e.g. notification of serious adverse events, unanticipated problems or non-compliance).

    Which studies are eligible for IRBshare?

    Federally-funded multi-site studies are eligible. For the first year, the UW will use IRBshare to rely on other institutions (rather than allowing others to rely on us). This means that at least one IRBshare member institution must have performed its IRB review and uploaded the review materials into the secure IRBshare server.

    When will IRBshare be available at UW?

    IRBshare is being piloted now and should be fully available by November 1, 2013.

    How do I obtain more information or submit a study?

    See the procedure SOP IRBshare or contact Shannon Sewards, Assistant Director for Biomedical Operations (ssewards@uw.edu; 206-543-2254) Your study coordinating center may also have information.

     


     

    Update: Revision of the Modification Form

    A couple of months ago we announced a pending revision of the Modification Form. The revision involves (1) conversion to a “smart” Adobe PDF form with branching logic, and (2) improvements in the questions about changes in investigators, staff, and involvement of other institutions. The complexity and length of this form have created some larger-than-expected technical and logistic challenges. Our new expected implementation date is the end of November.

     


     

    HSD Office Closed for Training

    The HSD office will be closed so that HSD staff may attend an all-day training session on October 21, 2013. The reception desk will still be open for the Office of Sponsored Programs, and can accept submissions for HSD and the IRBs, but nothing will be processed on that day. If you are aware of any impending deadlines, please take our office closure into account, and plan ahead.

     


     

    HSD Forms: A New Naming Convention

    HSD is implementing a new naming convention for our forms, to make them both more consistent, and easier to find on our website.

    The naming scheme will generally follow this formula: ACTION: Event, Audience. For example, the "Status Report - Renewal or Closeout - Form" becomes: "APPLICATION: Continuing Review (Status Report), Renew or Close". The Human Subjects Review Application: UW 13-11 will become: "APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee.

    The main keywords will remain in the title of the form, and the alphabetical forms list on our website will become much easier to scan and navigate. Look for the change mid-October.

    Send your questions or comments to Sherry Edwards, Information Manager at sherrye@uw.edu or 206-221-0994.

  • eNews re: IRB Review, August 30, 2013

    Sep 1, 2013 at 9:44am

    REVISED Policy about Lapsed IRB Approvals

    Effective August 30, 2013

    The change: Studies whose IRB approval has lapsed will now be closed approximately 60 days after the approval expires, instead of 90 days. Exceptions may be granted when researchers make other arrangements with the HSD staff person that manages the study for the IRB.

    This change will be implemented for all studies whose IRB approval expires on or after August 30, 2013.

    When IRB approval has expired, all research involving human subjects must stop except those activities that meet specific subject safety criteria. "All" includes (but is not limited to): subject contact; data collection; and data analysis. Activities that occur without current IRB approval are considered to be non-compliance.

    It is the researcher's responsibility to track IRB approval periods and ensure that IRB approval does not lapse. HSD sends reminders as a courtesy, but failure to receive or notice the reminders does not absolve researchers of this responsibility, nor does it change the consequences of a lapsed approval. The HSD reminders are:

    • An email to the lead researcher about 10 weeks before expiration
    • An email to the lead researcher about 6 weeks before expiration
    • An email to the lead researcher at or a few days before expiration
    • A Warning Letter sent by email and printed copy to the lead researcher and the study contact person, about 30 days after expiration

    Additional information is provided in a new policy and procedure document called SOP Lapsed Approval, posted to the HSD website on August 30, 2013.

     


     

    Research with Children

    New section on the Vulnerable Populations supplement

    The purpose of the new section is to provide researchers with a way to request a waiver of the requirement to obtain assent from children participants.

    Federal regulations require researchers to obtain assent from children. Sometimes it is appropriate to waive this requirement - for example, the children may be too young or may not have the cognitive capacity to provide assent.

    Until now, there was no mechanism for researchers to request a waiver of assent and to describe how their request meets the criteria for the waiver. This new section will reduce the need for "back and forth" between the researcher and the IRB about this issue.

    See the Protected and Vulnerable Populations Supplement.

     


     

    New Performance Metrics Report

    Performance metrics are now available for the six month period ending June 30, 2013. The new Report includes the latest turnaround time data for review of initial applications, exempt applications, and modifications.

    It also includes a new metric (see below) that will be a regular feature of all future reports.

    All of our metrics reports, including this Report #18, are publicly available from the upper right corner of the HSD home page.

    HSD has been gratified to receive compliments and inquiries about our metrics reports from IRBs and research administrative offices at other academic institutions. We encourage UW researchers to make use of this metrics information when planning the start-up activities for their research.

     


     

    New Metric: Analysis of Turnaround Time

    Our latest Metrics Report includes a new statistic that analyzes total turnaround time for IRB approval into two components: (1) IRB work time; and (2) Researcher response time.

    Figure 11 on page 15 of the report shows total turnaround time to receive IRB approval for new applications reviewed by the full IRB averaged 59.5 days. Our new analysis shows that:

    • 53% (31.5 days) = IRB work time* (i.e., time on HSD's "desk")
    • 47% (28 days) = Researcher response time (i.e., time on the researcher's "desk")

    *IRB work time includes:

    • Intake and assignment to an IRB
    • Pre-reviewing reading and screening
    • IRB member reading and preparation prior to a meeting
    • Scheduling application for IRB meeting
    • Writing and reviewing correspondence
    • Regulatory documentation

    We recognize that these are averages, and that individual cases may vary widely from these values. However, we hope that this new addition to our Metrics Report will be of interest and value to researchers.

     


     

    HSD Office Closed for Training

    The HSD office will be closed so that HSD staff may attend an all-day training session on September 16, 2013. The reception desk will still be open for the Office of Sponsored Programs, and can accept submissions for HSD and the IRBs, but nothing will be processed on that day. If you are aware of any impending deadlines, please take our office closure into account, and plan ahead.

     


     

    New and Revised Documents

    We generally release and post all new and revised documents on the last Friday of every month. Please see the list of document chagnes on our eNews online.

  • eNews re: IRB Review, August 16, 2013 - Special Edition, New SOPs, Tools and Policies

    Aug 16, 2013 at 11:37am

    HSD Changes are Here!

    Welcome to Part 2 (of 4) of the HSD eNews Special Editions.

    NEW SOPs, Tools, and Policies

    This spring HSD started a major project to write and/or revise IRB and HSD standard operating procedures (SOPs). This was prompted by two major federal audits. The project is also driven by the desire to increase clarity about requirements, IRB review consistency,and efficiency in training HSD staff and IRB members. It is also an opportunity to change some policies and develop some new tools. The first group of SOPs were posted and implemented at the end of June. The second group of SOPs were implemented and posted on August 9th. Most of them are completely new. Look for Parts 3 and 4 of our new SOPs in October and November.

    Summary of Changes

    Form Changes

    A few revisions were required because of the new SOPs. They are effective immediately, but no changes need to be made to already-approved applications or consent forms. Main IRB application form. The changes are:
    • New question about the use of the UW versus the Cancer Consortium IRB, for UW Cancer Consortium members.
    • New questions in the consent section, asking for a description of:
      • The consent process
      • The assent process (when the research participants include children)
      • Any translations or interpretation
    Consent template. Minor changes in wording, to more clearly address certain required elements of consent.

    Consent

    Of the new SOPs, these are the ones of greatest relevance to researchers. NEW Consent. Describes:
    • The regulatory and UW requirements for obtaining consent
    • The required elements of consent
    • Waivers of consent, and the criteria for granting them
    • How the IRB reviews the consent process
    • Procedures for obtaining consent from non-English speaking or illiterate participants
    • Situations for which re-consenting may be necessary
    NEW Consent Documentation. Describes:
    • The regulatory and UW requirements for documenting consent (e.g., consent forms)
    • Waiver of documentation of consent, and the criteria for granting it
    • How the IRB reviews the consent document
    • Procedures for obtaining consent documentation from non-English speaking or illiterate participants
    NEW Legally Authorized Representative (LAR). Describes requirements and procedures associated with obtaining consent from a legally authorized representative instead of the participant. REVISED Translation and Interpretation. Describes requirements and procedures, including new specific criteria used by the IRB to assess the method of translation or interpretation. Also includes new references to translation and interpretation resources.

    IRB Review

    This group completes the set of SOPs that describe the basics of the IRB review process. In June, we posted the SOPs about Minimal Risk Review (also called Expedited Review), Modifications, and Status Reports (also called Continuing Review). Highlights of this group include: NEW IRB Review. Describes the basic requirements and procedures for how the IRB conducts a review of any type (initial, modification, status report, etc.) NEW CHECKLIST Criteria for IRB Approval. This two page checklist is a new tool that is being used by the IRBs to guide and improve documentation of the review process. Researchers may find it useful to see the specific criteria that the IRBs are required to consider. NEW IRB Actions. Describes the actions the IRB is authorized to take (by regulation or by UW policy). Includes the procedures associated with the actions as well as the impact on researchers. Examples: approval; conditional approval; suspension. REVISED Certificates of Confidentiality. Several previous documents have been combined into one document to provide researchers and the IRB with a single place to go for information about this important mechanism for protecting participant confidentiality in sensitive research. It includes a "To Do" list for researchers, accompanied by a supporting flow chart. It also includes some minor policy changes:
    • Increased flexibility in the consent language used to describe the Certificate protections
    • Consistency about the timing of IRB approval relative to the timing of obtaining a Certificate

    IRB Operations

    This group of required SOPs describes IRB operations and logistics. We are posting them on our public website to de-mystify the behind-the-scenes process that supports IRB review.
  • eNews re: IRB Review, August 6, 2013

    Aug 8, 2013 at 9:19am

    WIRB Changes

    Western IRB (WIRB) reviews all industry-sponsored-and-initiated clinical trials for the UW. In the past year or so, WIRB was purchased by a new group and merged with another large, reputable, commercial IRB (Copernicus). The combined group is developing new systems, tools, and processes to provide better service to researchers and sponsors. UW researchers whose studies are reviewed by WIRB will receive email announcements about these changes, but we would like to draw your attention to one particular change: a new web portal. ConnexusTM is a secure web portal that is now an integrated part of the existing WIRBNet and can be used by both researchers and sponsors to:
    • Submit IRB applications, using web-based "smart" forms
    • Track the status of IRB applications, modifications, and renewals
    • Manage the study and the site participants
    • Organize documents
    • Access IRB application and approval documents
    This new ability to track the status details of an IRB application is especially important for researchers. It will improve your ability to plan and coordinate the many start-up components of a clinical trial. For more information, contact WIRB Client Services at clientservices@wirb.com or call 800-562-4789.

    Use of Central IRBs for Multi-Site Clinical Trials

    The default IRB review model for each site in a multi-site clinical trial is for each site to obtain IRB review from its own IRB. These multiple reviews by multiple IRBs can result in duplication of effort, delays, and increased expenses in the conduct of multi-site clinical research. There is growing national acceptance of the use of a central IRB for multi-site studies. Central IRB review involves an agreement under which the sites rely in whole or in part on the review of a single "central" IRB instead of the IRBs affiliated with the research sites. The goal is to increase efficiency and decrease duplicate efforts and workload by both researchers and IRBs that do not contribute to meaningful human subject protection. Recent National Institutes of Health (NIH) announcements soliciting grant applications for clinical trial networks or cooperative groups have made the use of a central IRB mandatory for any site that wishes to participate in those networks or cooperative groups. The UW and reliance on central IRBs. HSD agrees that the use of central IRBs is a sensible approach for many multi-site studies. We have recently signed agreements with some central IRBs.
    • WIRB (Western IRB) WIRB acts as the central IRB for industry-sponsored-and-initiated trials. Available since 2005. Contact HSD's Brecken Cardinal at hsdinfo@uw.edu
    • National Cancer Institute (NCI) Central IRB Almost all UW cancer-related studies have been reviewed for the UW by the IRB at Seattle Children's or the Fred Hutchinson Cancer Research Center. In July, the UW signed agreements with these two institutions and the NCI Central IRB. These agreements allow certain multi-site and cooperative group UW cancer studies to be reviewed by the NCI Central IRB instead of the local IRBs. Available now. Contact the IRB at Seattle Children's or the Hutch. https://www.ncicirb.org
    • IRBShare In this variation of the central IRB model, institutions share review documents and a review process. It is supported by a centralized, secure web portal and an IRBShare Master Agreement. HSD recently signed the Master Agreement. At the UW, IRBShare will be jointly administered by HSD and by the Institute for Translational Health Sciences (ITHS). See the HSD eNews in the next 2-3 months for more information. Available approximately November 1. Contact Shannon Sewards at HSD or Jason Malone at ITHS. https://www.irbshare.org/#what
    Limitations. These process are available only for new studies. Use of a central IRB does not necessarily reduce the amount of work required for initial review but it almost always is a faster process from submission to IRB approval. HSD is usually still involved in the process to manage and oversee local issues such as: requirements imposed by Washington State laws; and compensation for research-related injury. Applying for a grant that requires the use of a central IRB? We are happy to provide you with the requisite Letter of Support from the UW IRB. Contact Karen Moe (HSD Director) or Shannon Sewards (Assistant Director of Biomedical Operations).

    PAVE post approval monitoring program

    HSD is pleased to announce the formal launch of a new program called Post Approval Verification and Education (PAVE). The purpose of the program is to use a collegial approach to:
    • Confirm by observation that UW human subjects research is conducted in compliance with relevant regulations, policies, and IRB-approved procedures;
    • Provide specific education and tools to researchers, to address potential or actual research problems;
    • Identify and highlight best practices of UW researchers.
    Federal regulations provide Institutional Review Boards (IRBs) with the authority to conduct post approval monitoring of research studies. The UW program was developed and tested during the past year, based on similar programs already established at most of the UW's peer institutions. Participation in the program is mandatory, if your study is selected for a PAVE visit. However, note that the program's approach is educational, not punitive. Studies will be selected for a PAVE visit based on:
    • Random selection from among studies sharing specific characteristics. The characteristics used to identify these "not-for-cause" visits will be identified and publicized at the beginning of each academic year.
    • Requests from the UW IRBs and other sources.
    Not-for-cause visits will begin in August 2013. These studies will be selected from those with all of the following characteristics:
    • Domestic (not international)
    • Studies involving the use of an investigational drug or device, for which the UW researcher has an IND (Investigational New Drug permission) or IDE (Investigational Device Exemption) from the Food and Drug Administration
    • Study is still enrolling or still providing treatment/intervention to the subjects
    For more information see the PAVE FAQ on the HSD website, or contact Wendy Brown, Administrator & Monitor for the PAVE program at 206-543-5602 or wbrown3@uw.edu.
  • CITI Program Website Downtime for Software Upgrade

    Jul 29, 2013 at 8:18am

    Starting Monday, July 29, 2013 at 8 am, the CITI Program website will be unavailable for approximately two to three days to complete a major software upgrade.

    This software change will update many internal features of the CITI Program platform, and provide a new user interface designed to improve the experience of both learners and administrators.

    No access to the site will be possible during this downtime.  CITI apologizes for the inconvenience.

    For more information and FAQs about the upgrade, please see:

    http://citiprogram.desk.com/customer/portal/topics/465293-citi-program-2-0/articles

  • eNews re: IRB Review, July 2, 2013 - Special Edition, New SOPs, Tools, and Policies

    Jul 2, 2013 at 12:28pm

     

    HSD Changes are Here!

    Welcome to a special edition of the HSD eNews. It's a bit longer than usual, but we have many improvements and changes that we'd like to share with you.


    NEW SOPs, Tools, and Policies

    This spring HSD started a major project to write and/or revise procedures (i.e., standard operating procedures, or SOPs). This was prompted by two major federal audits. The project is also driven by the desire to increase clarity about requirements, IRB review consistency, and efficiency in training HSD staff and IRB members.

    We are very pleased to announce the implementation of our first group of SOPs. Many of them are completely new; for example, we have never before had a document about expedited ("Minimal Risk") review, or about IRB review when more than one institution is engaged in a research project.

    In parallel, we:

    • Developed several Worksheets as tools for researchers, HSD staff, and IRB members. For example, there is now a Worksheet about Human Subjects Research that will guide researchers through a self-determination about whether their project meets the regulatory definition of "human subjects research". See the New and Revised Documents at the end of this newsletter for a complete list of new/revised SOPs and new Worksheets.
    • Examined and revised some specific policies. Many (but not all) of these policies are relatively minor. However, these changes collectively should significantly reduce the time and/or requirements associated with IRB review for many researchers. The major changes are summarized below.

    We look forward to releasing additional SOPs, tools, and policy changes during the next six months! One of these will be the revised Modification Form we described in the March eNews, and the policy about which investigators are to be listed on applications and forms.  We expect these to be implemented later this summer.

     


     

    Summary of Policy Changes

    Definition of Research

    Activities that are not "research" as defined by the federal human subjects regulations do not require IRB review or exempt determination. The UW allows researchers to self-determine whether their projects are "research".

    Policy change. Revised or new definitions (interpretations) are now available for each component of the federal definition of "research". (See the WORKSHEET Human Subjects Research, Section 2.)

    Significance. It will be easier for researchers to self-determine whether their activities are "research".

    Eligibility for Exempt Status

    Exempt status means that a project is human subjects research but that it doesn't need to comply with the federal human subjects regulations. Research qualifies for exempt status when it involves no more than minimal risk to the participants and all of the research procedures fall into one or more specific categories.

    Policy changes. Changes related to the interpretation of "minimal risk" are being implemented:

    1. Research involving prisoners is no longer automatically excluded from exempt status, although several important limitations apply. (See SOP Exempt Determination, Section 6.2.1.)
    2. Research involving "third party" subjects is no longer automatically excluded from exempt status. (See SOP Exempt Determination, Section 6.6.)
    3. Research involving deception is no longer automatically excluded from exempt status, although some limitations apply. (See SOP Exempt Determination, Section 6.7.)
    4. Though HSD continues to promote the use of a consent process in exempt research, HSD no longer requires exempt research to provide subjects with certain specific information.

    Significance. Collectively, these changes mean that more research will qualify for exempt status.

    Eligibility of Modifications for Expedited Review ("Minimal Risk" Review)

    Federal regulations allow modifications for studies that are normally reviewed by a full IRB committee to be reviewed by a single IRB member (expedited or "Minimal Risk" review) instead of the full IRB, when the modification involves no more than a minor change. The regulations do not define "minor change".

    Policy change. HSD has developed a definition of "minor change". (See SOP Expedited Review, Section 3.3.)

    Significance. This means increased predictability in how modifications are reviewed.

    Triage Process

    HSD Staff assess IRB and exempt applications before review, to ensure that applications are complete. Occasionally the staff notice that an application qualifies for a "lower" level of review. For example, the project described in a Minimal Risk application might qualify for exempt status.

    Policy changes.

    1. All new IRB and exempt applications will now be routinely assessed by HSD staff, to identify the "lowest" appropriate level of review. Whenever possible, that review will be conducted using the materials provided by the researcher, even when the application form is not the "correct" form.
    2. All new applications reviewed by a full IRB: when the IRB grants approval, it will also determine whether the subsequent Status Report and Modification reviews can be reviewed by the expedited (Minimal Risk) procedure instead of requiring the full IRB.
    3. All Status Reports reviewed by a full IRB: when the IRB grants approval, it will also determine whether subsequent Status Reports can be reviewed by the expedited (Minimal Risk) procedure instead of requiring the full IRB, or whether the IRB file can be closed.

    Significance. Unnecessary applications (i.e., for activities that are not Human Subjects Research) will be triaged and returned before beginning the review process. More studies will qualify for exempt status or expedited (Minimal Risk) review.

    Research Collaborations or Multiple Performance Sites

    UW research projects may involve multiple non-UW institutions, locations, and individuals. The default position of the federal regulations and the UW is that each institution engaged in a research project must provide IRB review and approval of its own participation in the research. This is called "dual review". Until now, the UW has been willing to reduce dual review by allowing other institutions to rely upon the UW IRB but we have been unwilling to defer review to other IRBs.

    Policy change.

    1. The UW is committed to reducing (as appropriate) duplicate reviews due to the engagement of multiple institutions, through the use of cooperative agreements, central IRBs, and study-specific agreements with IRBs at other institutions. (See SOP Research Collaborations or Multiple Performance Sites, Section 2.4.)
    2. The UW IRB is willing to rely upon the review of another institution's IRB, in certain circumstances. (See SOP Research Collaborations or Multiple Performance Sites, Section 7.)
    3. When dual review is unavoidable, UW researchers will no longer be required to provide documentation of the other IRB's approval in order to obtain UW IRB approval. However, UW researchers are still responsible for obtaining and maintaining documentation of all required IRB approvals in their research records, which are subject to post-approval monitoring by HSD.

    Significance. More UW studies involving non-UW collaborations will require review by only one IRB. When more than one IRB must be involved, there will be fewer intractable inconsistencies between the IRBs. UW IRB approval will be granted more quickly because the prior need to provide the UW with documentation of approval of other IRBs was typically the rate-limiting step in the UW IRB approval process.

    Grant Applications

    Federal regulations require the IRB to compare for consistency the information contained in the IRB application with the information in the grant application that is funding the research.

    Policy changes.

    1. It is no longer necessary for every discrepancy between a grant application and an IRB application to be identified and resolved by the IRB. Instead, the consistency review will focus only on the specific information relevant to IRB review and approval. (See SOP Funding Review, Section 5.1.1.)
    2. It is no longer necessary to provide a complete copy of a center, program, or institutional training grant application when such grants provide support for a research project. Instead, specific sections are required. (This will significantly reduce the amount of paper and copying required for these projects.)

    Significance. There will be reduced "back and forth" on the consistency issue. Also, there will be a significantly reduced amount of paper and copying for center, program, and training grants (which are exceptionally large).


    New and Revised Documents

    Please see our eNews online for the full list of updated documents.

     

  • eNews re: IRB Review, May 31, 2013

    May 31, 2013 at 3:10pm

    HSD Changes are Here!

    HSD has begun the process of implementing new and updated policies, procedures, and forms. Many are planned improvements that are near completion.  

    This end-of-the-month newsletter is our single most important way to communicate changes. We work hard to make it short, useful, and readable.  We post it on our home page http://www.washington.edu/research/hsd/ (announcements tab at the bottom), or you can subscribe directly by sending an email to hsdinfo@uw.edu.

     

    HSD Office Closed for Training

    The HSD office will be closed so that HSD staff may attend an all-day training session on June 17, 2013. The reception desk will still be open, and can accept submissions for HSD and the IRBs, but nothing will be processed on that day. If you are aware of any impending deadlines, please take our office closure into account, and plan ahead.

     

    New Set of Questions on Main Application Form

    The Human Subjects Review Application (UW 13-11) has a new set of questions that will aid in faster and improved assignment to the appropriate IRB committee.

    The questions ask you to select methods, any special populations, and what type of risk you believe your research involves. The questions are simple, with easy selection boxes that should take very little time to answer and will save time once your application reaches the HSD office.

     

    New Response Cover Sheet

    HSD wants your responses to quickly get to the right IRB or HSD staff! We are consolidating our Deferral and Screening Response cover sheets into a single Cover Sheet.

    This new Cover Sheet can be used for all responses (except Conditional Approval Responses) to the IRB or HSD, including: deferral response, pre-review screening response, and responses providing requested materials such as a grant application, a Confidentiality Agreement, or a consent form. (Conditional Approval responses still have their own form.)

    Please begin using this cover sheet as soon as possible. As of September 30, 2013, we will no longer accept responses or other requested materials without this cover sheet.

     

    Revised Form Section for Lead Researcher and Contact Information

    This section is one of the first sections you see on almost every IRB form. Each form has had its own idiosyncratic version of this section. HSD has now standardized the information requested in this section. We also call out the need for a physical mailing address that is the best place to send paper correspondence.

     

    Revised "Report Problems" Web Page

    We have revised the webpage that describes what types of problems must be reported to the IRB and (just as important) which problems do not need to be reported. The content has been revised and re-organized to improve clarity and to provide specific additional information about certain types of problems.

    Please see the updated page here: http://www.washington.edu/research/hsd/topics/Report+Problems+%28Compliance%29.

     

    New and Revised Documents

    Read our eNews online for a full list of document updates.

  • Changes Coming to HSD!

    May 23, 2013 at 1:23pm

    Changes Coming to HSD!

    In order to better serve the UW research community, and to address the findings of two recent federal audits of the UW IRBs, HSD will be implementing numerous changes to our policies, procedures and forms over the next six months. All changes are being made to improve HSD's compliance with federal and state regulations and to improve the quality and consistency of IRB review at UW. Many of these changes will also reduce or streamline the IRB-related work required from researchers.
    Changes to Look for Soon*:
    • Which investigators and study staff are listed on HSD forms and applications
    • The names and contact information will be required only for individuals who are fulfilling specific roles on the research team (Principal Investigator, Contact Person for the Subjects, Licensed Practitioner (if applicable), Study Coordinator and Faculty Advisor (if applicable)).
    • Which investigators and study staff are listed on consent forms
    • Consent forms will need to list only the names and contact information for the Principal Investigator and the Contact Person for the Subjects (if different from the PI). No other members of the research team will need to be listed. This will significantly reduce the number of modifications submitted for many studies.
    • Reformatted and revised Modification Form
    • The Modification Form is being revised to reflect the above two changes (as well as some other content changes). We have also put the form into a PDF Smart Form format so that it is easier to follow and fill out (and easier for HSD staff to review). This will also result in a much shorter form for most modifications.
    *We are targeting an August implementation (subject to change). Details on these changes and others can be found in the monthly HSD eNews.
    For More Information
    Be sure to check the Announcements Tab on the HSD Website:
    Please Send All Questions To: hsdinfo@uw.edu
  • eNews re: IRB Review, May 13, 2013 Special Mid-May edition

    May 13, 2013 at 12:05pm

    NEW WIRB Service

    For researchers who want personalized service and faster turnaround time for their industry trials

    WIRB has a Clinical Pharmacology Unit (CPU) that offers faster and more personalized services for industry-sponsored clinical trials of drugs, for a somewhat higher fee than the standard process. This service is already in use by several UW investigators for research that is especially sensitive to trial start-up times. The following information has been posted to the WIRB pages of the HSD website:

     

    NEW UW-WIRB Process Flow Chart

    To provide a snapshot overview of the UW process for industry clinical research that will be reviewed by WIRB

    HSD is revising and consolidating the information and procedures for researchers who are planning to submit an IRB application to WIRB for industry-sponsored research. The revisions will be posted within the next two months. In the meantime, this one-page high-level flow chart provides a snapshot overview of the process - including information about the timing of contract negotiations and budget preparations.

     

    NEW Standard Operating Procedures (SOPs)

    This trio of SOPs is the first of many new or revised SOPs that HSD will be posting during the next five months. They describe policies and procedures for researchers, the IRBs, and HSD staff.

    IRB Actions

    This SOP describes the meaning, procedures, and criteria for the basic actions that the IRB can take: approval; conditional approval; deferral, disapproval; suspension; and termination.

    Modifications

    Among other things, this SOP describes the factors that influence the HSD decision about whether a modification:

    • Should instead be submitted as an application for a new study.
    • Is a "minor change" and therefore can be reviewed by the expedited ("Minimal Risk") process instead of the full IRB committee.

    Continuing Review

    This SOP describes everything you might want to know about Status Reports, including:

    • The criteria used to review and approve Status Reports.
    • The factors the IRB considers when deciding the duration of your IRB approval period.
    • The factors the IRB considers when deciding whether to require verification of information in the Status Report, from sources other than the researcher.
    • The consequences of lapsed IRB approval.
  • eNews re: IRB Review, April 30, 2013

    Apr 30, 2013 at 2:18pm

    Many HSD Changes Coming Soon!

    HSD will be implementing many policy, procedure, and form changes in the next six months.  Read more about this month's changes in our eNews.

     

    NEW POLICY: Release of Certain Types of Funding

    Easier and faster access to funding for certain types of awards.  Read about the change from Limited Activities Determination to Delayed Onset Human Research in our eNews.

     

    HSD Office Closed for Training

    The HSD Office will be closed for staff training on May 20, 2013.  Read more detail in our eNews.

     

    WIRB Related Changes

    Read more about improvments and additional tools to help researchers.

     

    Conditional Approval: An Audit Issue

    A recent federal audit of the UW IRB found that the IRBs were inappropriately granting Conditional Approal to studies that should instead have been Deferred. Read the details about how this will affect you.

     

    Quick Tips from HSD

    This months Quick Tips is on "Exculpatory Language."  Read it in our eNews, or two tabs over on our home page under "Quick Tips".

     

    New and Revised Documents

    HSD typically uploads new and revised documents at the end of the month unless there is an urgent need.  Read all about April's updates here.

  • Easier and Faster Access to Funding

    Apr 15, 2013 at 8:10am

    Effective May 1, 2013

    Impact on researchers: Easier and faster access to funding for certain types of funding awards.

    Funding for human subjects research cannot be released by OSP until the researcher has obtained one of these from HSD: IRB approval; exempt status; or a Limited Activities Determination (LAD).

    NEW POLICY: Recent federal clarification makes it possible for us to expand the types of grants that are eligible for a LAD determination.  This is great news for researchers, because the LAD form is short, easy to complete, and quick for HSD to review.  The specific changes are:

    1. NEW NAME: Delayed Onset Human Research (DOHR).

    We know that name changes can be annoying, but the National Institutes of Health (NIH) recently started using the label "Delayed Onset Human Research" for this type of determination.  Using the same label as NIH should ease the use of this mechanism for releasing funds.

    2. EXPANDED TO ADDITIONAL FUNDING SOURCES:

    The LAD was limited to research that required significant development work prior to involvement of human subjects.  Now, researchers can obtain a DOHR determination (and thereby obtain access to funds right away) for these additional types of awards. (a) award mechanisms whose only human subjects research is funding for small projects or trainees that will be selected and funded by the awardee; and (b) clinical research networks or consortia that will create protocols over the course of the award.

    3. EXPANDED TO ADDITIONAL TYPES OF AWARDS:

    The LAD was limited to federal funding administered through OSP.  The DOHR has been expanded to include funding from non-federal entities administered through OSP (except when specifically not allowed by the award conditions).

     

    The DOHR Application process is the same as the LAD process: complete the short simple form; HSD makes a quick determination; HSD sends the researcher a memo to be submitted to OSP and then to the funding agency.

    The information will be uploaded to the HSD website on Friday, April 26th. Watch your email inbox for the HSD eNews.

  • eNews re: IRB Review, March 29, 2013

    Mar 29, 2013 at 11:14am

    Many HSD Changes Coming Soon!

    HSD will be implementing many policy, procedure and form changes in the next six months. Many are planned improvements that are near completion. Other changes are required because of two recent federal audits of the UW IRB.

    This end-of-the-month newsletter is out single most important way to communicate changes. We work hard to make it short, useful, and readable. You can read it here, on the announcements tab, or subscribe by sending an email to hsdinfo@uw.edu.

     

    Minimal Risk Delays

    HSD has many new staff, particularly among the Minimal Risk teams. Unfortunately, this has occurred at the time of year when we have the highest volume of Minimal Risk applications.

    Turnaround time for many (but not all) Minimal Risk reviews is significantly longer right now. We greatly appreciate your patience while we continue hiring and training the new staff for this important area of our office.

     

    Use of Synthetic Nucleic Acid Molecules with Humans

    Effective: March 2, 2013

    A new NIH policy now required the UW Institutional Biosafety Committee (IBC) to review for all studies involving the deliberate transfer into humans of synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules that meet specific criteria. Three of our forms have minor changes. Read the full story here.

     

    "Smart Form" Version of the Modification Form

    HSD is converting the Modification Form to a PDF "smart" form. Read the details in our eNews.

     

    Human Subjects Protection Training

    Did you know that the UW Human Subjects Division doesn't require all researchers to obtain training in the protection of human subjects? The only requirements you have to follow of those of the funding agency. Read the details here.

     

    Quick Tips from HSD

    This quick tips highlights some good information on encryption. Read it in the eNews, or over on the "Quick Tips" tab.

     

     

     

     

  • eNews re: IRB Review, March 8, 2013

    Mar 13, 2013 at 11:29am

    Financial Disclosure in FDA-Regulated Research

    New Guidance: "Financial Disclosure by Clinical Investigators"

    Effective: February 26, 2013

    The Food and Drug Administration (FDA) has published the final version of its guidance on financial disclosure by investigators. The guidance was developed in response to a 2009 report from the Office of the Inspector General that criticized the practices of investigators, clinical trial sponsors, and the FDA on this issue. Find out what this means for researchers by reading the full article here.

     

    Children in FDA-Regulated Research

    New Regulations

    Effective: March 28, 2013

    The Food and Drug Administration (FDA) has amended its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products.

    The new regulations are called Subpart D of the regulations of 21 CFR 50. This will have little or no impact on UW research, as the new FDA rules are almost identical to the other major set of federal rules about children in research. Read more in our eNews.

     

    WIRB Fee Schedule Change: Effective 1/7/13

    WIRB has changes its fee scheduled effective January 7, 2013.  See the revised fee schedule here.

    Please note that an additional one-time fee of $1,500 must be paid to the Human Subjects Division. The Office of Sponsored Programs and the Clinical Research Budget and Billing Office will add this to the study budget when it is developed.

     

    Semi-Annual Metrics

    HSD is decreasing the publication rate of its metrics from quarterly to semi-annually. Read the details here.

     

    Quick Tips from HSD

    Modifications Happen.  Read the full article here, or browse to the Quick Tips tab on our home page.

     

  • eNews re: IRB Review, February 1, 2013

    Feb 12, 2013 at 1:46pm

    Exempt Wizard

    The University of Washington, along with a number of other institutions, has chosen to participate in a demonstration run by the Federal Demonstration Partnership (FDP) of an electronic "wizard" that will allow investigators to "self-determine" if their project requires review by an IRB or if it meets the federal definitions of exempt. To obtain sufficient data to test the efficacy of the demonstration, each institution has been requested to ask a limited set of researchers that have had recently reviewed projects to complete the "wizard."

    Learn more about this project in our eNews.

    New Pilot Program: Committee J

    When an application is submitted to our office, it goes directly to a minimal risk or full board committee depending on the box checked on the application. When a study is inaccurately or inadvertently submitted to the wrong type of committee, it goes through initial review and then must be transferred to the appropriate committee. This transfer process slows down review considerably. We are piloting a new project to make this process more efficient by combing a minimal risk committee and a full board committee into one committee J/EJ.

    New and Revised Documents

    Read our online eNews to see which documents were updated to align with the new FCOI rules

    HSD Quick Tips

    In this edition of eNews, we discuss when you need to notify the IRB that you are dropping a procedure.

  • HSD Metrics: Report 17 (7/1/12 to 12/31/12)

    Feb 4, 2013 at 11:30am

    The 17th Report of HSD Performance Metrics (for reporting period 7/1/12 to 12/31/11) has been posted to the HSD website.  Information about turn-around times and other key aspects of the IRB review process can be found in the report at http://www.washington.edu/research/hsd/docs/1608 along with reports from previous quarters.

     

  • eNews re: IRB Review, December 20, 2012

    Jan 3, 2013 at 9:57am

    Federal Demonstration Partnership Exempt Wizard

    The Federal Demonstration Partnership (FDP) has created a relatively short smart form to test pilot the effectiveness of investigator determinations of exemption.

    Studies that received an exempt determination will be randomly chosen, and the investigators will be asked to participate.

    For more details see our eNews story.

     

    Registration of Clinical Trials

    The Protocol Office at Fred Hutchinson Cancer Research Center (FHCRC) has agreed to continue to do the registration for UW investigators whose research is reviewed by the FHCRC IRB on behalf of the UW IRB.  

    Please read the full story in the December eNews.

     

    New Clinical Trials Administrator

    December 31, 2012: Arna Elezovic's last day

    January 10, 2013: Brecken Cardinal's first day

    Arna Elezovic is leaving the Human Subjects Division at the end of December.  Read more about her transition to full-time graduate student, and learn about Brecken Cardinal in our eNews.

     

    REMINDER - The New Use of Identifiable Biological Specimens/Data Form is Here!

    If you will be conducting research that only involves identifiable biological specimens and/or data, a substantially revised form with new guidance has been created titled: Use of Identifiable Biological Specimens/Data.  These have replaced the old "Medical Records Review" form and instructions.

    We no longer accept the old Medical Records Review form.  For details read our eNews.

     

    New and Revised Documents

    Please see the eNews for this month's document revisions.

     

    Quick Tips from HSD

    This month we talk about the Washington State IRB.  Read it in the eNews, or see the new "Quick Tips" tab on our home page.

     

  • eNews re: IRB Review, November 30, 2012

    Dec 1, 2012 at 2:32pm

    New Required Data Elements for ClinicalTrials.gov

    New requirements increase the number of data elements that must be submitted to ClinicalTrials.gov for each initial trial registration.  Effective December 1, 2012 the following data elements will be required to post a new study record:

    • Responsible Party
    • Primary Completion Date
    • At least one Primary Outcome Measure
    If you have general questions, please contact the UW Compliance Administrator, Stefan Shipman at sshipman@uw.edu.

    Medical Records Review Form Substantially Revised!

    The Medical Records Review form has officially been replaced by the Use of Identifiable Biological Specimens/Data form.  HSD will no longer accept the old Medical Records Review form as of December 31, 2012.  Please read the eNews for full details on the use of this new form.

    New Metrics Available

    The 16th Report of HSD Performance Metrics (for reposting period 4/1/2012 to 9/30/12) has been posted to the HSD website.  This report includes a new metric and analysis of "Minimal Risk" reviews.  Turn-around times are now distinguished by type of application form.

    • The standard application has a median turn-around time of 23 business days.
    • The medical records review form (soon to be replaced by the Use of Identifiable Biological Data/Specimens form) has a median turn-around time of 14 business days.
    Information around turn-around times and other kay aspects of the IRB review process can be found in the report along with reports from previous quarters.

    2013 Update to the International Compilation of Human Research Standards

    The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations.  The Compilation is designed for use by IRBs, researchers, sponsors, and others.  Many of the listings embed hyperlinks to the source document.

    The 2013 edition is now available, and can be accessed in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html. One new country is featured in the 2013 Edition: Ecuador.

    As in the past, the new edition updates the human research standards based on information provided by in-country experts.

    New and Revised Documents

    Please read the eNews for a listing of revised documents for the month of November.

    Quick Tips from HSD

    This month's quick tips describes how to use the new PDF version of the Use of Identifiable BIological Specimens/Data form to communicate back and forth between researchers, and research coordinators.  Please read the eNews for details.

  • eNews re: IRB Review, October 11, 2012

    Oct 17, 2012 at 8:20am

    Cancer Consortium Studies and the UW Injury Compensation Program

    There has been long-standing confusion about whether UW oncology stuides reviewed by the Hutch's Cancer Consortium IRB are eligible for the UW Injury Compensation program.  This program provides health care for research-related medical problems, at no cost to the research subjects.  It also provides limited rembursement for out-of-pocket expenses incurred by subjects because of research-related medical problems.

    A simple flow chart has been posted on our website that describes the decision making process.  Read our eNews online for more detailed information.

     

    REMINDER & NEW TIMELINE - Revised Medical Records Form

    If you will be conducting research that only involves identifiable biological specimens and/or data, a substantially reviwed form with new guidance has been created titled: Use of Identifiable Specimens/Data.  These replace the old "Medical Records Review" form and instructions.

    Please read the eNews for more details.

     

    New and Revised Documents

    See our eNews for details on new and revised documents.

     

    Quick Tips from HSD

    When to use the new form: Use of Identifiable Biological Specimens/Data

    Find out when the new form should, and shouldn't be used by reading our eNews.

     

     

  • Revised FCOI policies GIM-10 and GIM-7 are now available

    Aug 23, 2012 at 10:58am

    The revised FCOI policies GIM-10 and GIM-7 are now available.  The policies have been revised to ensure compliance with the new PHS FCOI regulations.  Investigators must comply with the revised policies beginning with today’s date, August 24, 2012. We will keep you updated through the FCOI Website on further implementation and process enhancements.  Please contact the Office of Research at research@uw.edu with any questions.

  • Financial Interest Disclosure System (FIDS) is now available.

    Aug 21, 2012 at 10:44am

    The Financial Interest Disclosure System (FIDS) is now available and replaces the current paper-based system to submit Significant Financial Interests (SFI) disclosures.  Now, Investigators must use FIDS to electronically submit their SFI and travel disclosures.   For more information, please see the FCOI website.

  • Medical Records Review Form Substantially Revised!

    Aug 13, 2012 at 8:37am
    If you will be conducting research that only involves identifiable biological specimens and/or data, a substantially revised form with new guidance has been created titled: Use of Identifiable Specimens/Data. These replace the old "Medical Records Review" form and instructions. The form is limited to researchers who are not directly interacting with people, but who are reviewing identifiable private information about individuals and/or analyzing identifiable specimens. When should you complete this application? Here are some examples of projects that involve review of identifiable information or specimens (either retrospective or prospective) that are appropriate for this form:
    • medical records;
    • protected health information (PHI);
    • employment data;
    • study records;
    • pathology specimens;
    • data and/or specimens from a repository.
    The deployment of a revised Use of Identifiable Specimens/Data form and guidance will involve a beta-testing phase:
    Step 1 - Friday, 8/10/2012 - a PDF version of the Use of Identifiable Specimens/Data will be made available for beta-testing, along with the guidance document.
    Step 2– Friday, 8/10/12 through Thursday, 11/15/12 – Please direct comments/questions about the form to hsdinfo@uw.edu
    Step 3 - Friday, 11/30/2012 (target date) – All received comments will be incorporated. A finalized PDF form and guidance will be made available.
    The form is available on the HSD website:
    http://www.washington.edu/research/hsd/docs/1377
    and should be used in direct conjunction with the guidance:
    http://www.washington.edu/research/hsd/docs/1357

    As of December 31, 2012, HSD will no longer accept the old "Medical Records Review" form.

    Please direct any questions about the form to hsdforms@uw.edu.
  • eNews re: IRB Review, August 10, 2012 New Form!

    Aug 13, 2012 at 8:33am

    Medical Records Review Form Substantially Revised!

    If you will be conducting research that only involves identifiable biological specimens and/or data, a substantially revised form with new guidance has been created titled: Use of Identifiable Specimens/Data. These replace the old "Medical Records Review" form and instructions. 

    Please read the eNews for more details.

     

    New Assistant Director of Social-Behavioral Operations

    HSD is pleased to announce that Emily Guthrie has accepted the position of Assistant Director of Social-Behavioral Operations, beginning August 16th. For more information, read our online eNews.

     

    HSD Home Page Improvements

    A new interface will soon be added to the HSD home page.  This guide is designed to help those new to research, and those new to the UW begin to navigate their way through the HSD/IRB process.  Watch our home page for changes.

     

    Quick Tips from HSD

    Registry and Repository 

    Have you wondered why HSD refers to a collection of data sometimes as a Registry and sometimes as a Repository?  Read our eNews to find out why!

  • eNews re: IRB Review, June 22, 2012 FCOI Training Available

    Jul 10, 2012 at 8:37am

    New FCOI Training Available

    Starting August 24, 2012, Public Health Service (PHS) funded investigators or investigators anticipating receiving PHS funds must complete the online FCOI training prior to the expenditure of funds on any new award.  Read more in our online eNews here

    E-Mail Confidentiality Statement Update

    In the past, we have required that in each document in which e-mail contact is solicited or suggested, the following statement is to be included: "Please note that we cannot guarantee the confidentiality of e-mail communications."  As of June 4, 2012, the inclusion of the e-mail confidentiality statement is no longer a requirement.  More information is available in our online eNews letter.

    Emergency Medicine Research

    Effective immediately, IRB Committee A will review all new applications for research that involves the emergency exemption to informed consent, aka "Emergency Medicine" interventions.  More detailed information is available in our online eNews letter.

    Quick Tips from HSD

    Learn about Records Management and their role in research records maintenance.  UW-GS 7 explained.

  • eNews re: IRB Review, May 29, 2012 Updates to Main Forms

    Jun 11, 2012 at 2:29pm

    Use of the UW IRB

    New Policy

    Read about the new HSD policy that descrives the eligibility criteria for using the IRB in the eNews Article of the same name.

     

    Revisions to the Most Commonly Used Forms

    New questions have been added to the most commonly used forms from HSD.  Read the details in the eNews.

     

    New Metrics

    HSD published the 14th Metrics report using data from our "new" database.  Read the report here.

     

    Exempt Status Request Guidance: Additions

    Additional definitions have been added to the Exempt Status Request Guidance.  Read about the additions in detail in our eNews.

     

    New ClinicalTrials.gov Contact

    Effective immediately, the University's liaison with ClinicalTrials.gov is Compliance Administrator, Stefan Shipman. Read more on our eNews.

     

    New and Revised Documents

    See the list of revised documents for the month of May.  This list doesn't include the adjustments to the main applications listed above.

     

     

  • New FCOI training available

    Jun 7, 2012 at 10:38am