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  • Read the latest OR Horizon; articles and updates from the Office of Research

    Nov 13, 2014 at 5:55pm

    Read the latest OR Horizon; articles and updates from the Office of Research.

  • 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

  • The Academic Ranking of World Universities ranks UW at 15 (up from 16)

    Oct 17, 2014 at 3:13pm

    The UW is ranked 15 by the Academic Ranking of World Universities (up from 16), and rated 6 in the world in Life and Agriculture Sciences (2014 rankings). See: http://www.shanghairanking.com/ARWU2014.html

  • 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
  • Biosafety Stewardship

    Sep 10, 2014 at 1:55pm

    Biosafety Stewardship

    Recent lapses in biosafety practices at federal laboratories have prompted the National Institutes of Health (NIH) to urge grantees to participate in National Biosafety Stewardship Month this September. UW strongly encourages principal investigators (PIs) and laboratory directors to inventory biohazardous agents and reexamine lab policies and procedures that impact biological safety.

    Other Health and Human Services agencies are joining the NIH in this effort, and the White House has issued a statement recommending a "safety stand-down" of federal departments and agencies.

    You can help ensure biosafety stewardship with these steps:

    1. Inventory and document stocks and cultures stored in your lab.
    2. If biohazardous agents are not registered with Environmental Health & Safety (EH&S), update your Biological Use Authorization.
    3. If stocks or cultures are no longer needed, decontaminate and dispose of them properly.
    4. Make sure biosafety training is completed and current.

    For assistance, contact EH&S at 206.221.7770 or ehsbio@uw.edu.

  • 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.

  • The Office of Research Newsletter, OR Horizon

    Aug 22, 2014 at 11:41am

    The Office of Research Newsletter, the OR Horizon on the connection of Reseach and Technology

  • $31M gift will fund early stage UW research by high-tech entrepreneurs

    Jul 14, 2014 at 8:01am

    The University of Washington is receiving a $31.2 million gift from Washington Research Foundation to boost entrepreneurship and support research that tackles some of society’s most crucial challenges.

    The award will fund four interdisciplinary initiatives that seek to advance global innovation in clean energy, protein design, big data science and neuroengineering.  See the article in UW Today.

  • 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.

     


  • UW Ranked #25 by Times Higher Education

    Mar 21, 2014 at 1:02pm

    Seattle PI wrote, "The University of Washington is one of the World's Top 30 universities, according to Times Higher Education's 2013-14 ranking.

  • 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.

  • Office of Research Campus Update - December 2013 Issue

    Feb 10, 2014 at 10:26am

    Please see the Office of Research Campus Update for articles on research administration at the UW.

  • 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

     


     

    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

    The online Financial Conflicts of Interest (FCOI) training is now available at http://uw.edu/research/fcoi. Starting August 24th, 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 awards.

  • eNews re: IRB Review, April 13, 2012 - Compliance Updates

    Apr 16, 2012 at 8:51am

    HSD Compliance Updates

    One new, and one updated guidance document help clarify and describe "research inquiries" and "out-of-window" visits.  Please read about them online in our eNews:

    Inquiries and Complaints

    Out-of-Window Study Visits: Reporting to the IRB is no longer required

     

    WIRB Fee Schedule Change: Effective 6/1/2012

    Increases to WIRB fees have been posted to the HSD Web site.  Read more about it here.

     

    Presidential Commission for the Study of Bioethical Issues: Request for Comment

    Public comment is requested on the ethical issues raised by the ready availability of large-scale human genome sequence data, with regard to privacy and data access and the balancing of individual and societal interests.  Find out more.

     

    New and Revised Documents

    Read about the documents updated for March, 2012.

     

    Quick Tips from HSD

    What does the term "Exempt" really mean?  Read about this and some common misconceptions in our eNews.

  • HSD Performance Metrics: 13th Report Posted

    Mar 26, 2012 at 9:19am

    The 13th Report of HSD Performance Metrics (for reporting period 7/1/11 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/1352 along with reports from previous quarters.

  • eNews re: IRB Review, March 16, 2012

    Mar 16, 2012 at 10:00am

    Important Considerations

    Read the HSD online eNews for some important things to consider when planning your human subjects research project.

    What is considered support for a research project?

    Do you need prospective IRB approval to drop an approved research procedure or group of subjects from your project?

    Data protection: what do you need to do?

     

    Updates to the Consent Form Template

    The language in the Consent Form Template has been updated.  Read the details in our newsletter.

     

    Correction to Description of Training Requirements

    The document describing UW's policy on human subjects training requirements has been revised.  Read about it online, or see sections 1.3 and 1.4 for the changes: http://www.washington.edu/research/hsd/docs/827

     

    New and Revised Documents

    Read about the documents updated for the month of February.

     

    Quick Tips from HSD

    Student Research?  Learn about when student research DOES need to go through the HSD/IRB process in our online eNews.

     

  • eNews re: IRB Review, February 21, 2012

    Feb 24, 2012 at 2:04pm

    Signature Policy Change

    A revision to the HSD Signature Policy should ease the burden of obtaining the original ink signatures on forms. The exception to this new policy is the UW Confidentiality Agreement.

    Read all the details in the eNews online.

    Expiring Approvals in Principle

    If you have an Approval in Principle (AIP) that is expiring, you will need to submit either a full IRB Application, or apply for a Limited Activities Determination (LAD).

    Read more in the eNews

    WIRB Updates the Initial Review Submission Forms

    WIRB's initial review submission forms have been revised and are available for use on their website.  The new version will be required March 1, 2012.

    New Staff at HSD

    Over the past several months, HSD has been lucky enough to fill several vacant positions with a great group of people.  Read more about them in the eNews.

    New and Revised Documents

    Read about the documents updated with the revised Signature Policy, and some helpful formatting updates to our Federalwide Assurance documents.

    Quick Tips from HSD

    Classroom Research Project?  Learn about when student research does not need to come to the IRB in our online eNews.

  • eNews re: IRB Review, January 10, 2012

    Jan 11, 2012 at 10:24am

    In this issue:

    Adverse Event Reporting

    The timeframe for submitting a copy of the Adverse Event Report has increased from 24 hours to 10 business days from the time you become aware of the event.  Read the full story online at eNews.

    Over-enrollment and Subject Numbers

    Due to confusion regarding the revisions to the subject numbers sections of the main Human Subjects Review Application and the Status Report form, HSD is quickly working to address the problem by refining the questions.  

    Read the details at eNews.

    Quick Tips from HSD

    A new feature from HSD that sheds light on troublesome IRB terms.  This month:  Expedited Review

    Read more online at eNews.

     

  • eNews re: IRB Review, December 1, 2011

    Dec 7, 2011 at 8:56am

    In this issue:

    Over-Enrollment

    HSD has posted a revised policy and guidance document on the topic of "over-enrollment." Located on the HSD website at: http://www.washington.edu/research/hsd/docs/1251; this document provides important invormation about what constitutes over-enrollment and its consequences.

    Read the full story online at eNews.


    Global Health Reviewers Launches Website

    This interactive website supports ethics committees and institutional review boards around the world.

    Read the detail at eNews online.


    New and Revised Documents

    Please see the eNews for details on document revisions pertaining to over-enrollment and subject numbers.

  • HSD Performance Metrics: 12th Report Posted

    Nov 16, 2011 at 1:39pm

    The 12th Report of HSD Performance Metrics (for reporting period 4/1/11 to 9/30/11) 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/1335 along with reports from previous quarters.

  • HSD Performance Metrics: 11th Report Posted

    Oct 11, 2011 at 8:21am
    The 11th Report of HSD Performance Metrics (for reporting period 1/1/11 to 6/30/11) 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/1329 along with reports from previous quarters.
  • eNews re: IRB Review, September 1, 2011 - Extended Deadline for Comments on Proposed Regulatory Changes

    Sep 1, 2011 at 3:46pm

    Federal agencies have extended the deadline to October 26th for submitting comments about the proposed changes to the federal human subjects regulations.

    The new deadline for submitting comments to Karen Moe, for inclusion in a comment to be submitted by the Human Subjects Division, is now October 10th.   Please contact Karen at kemoe@u.washington.edu or 543-0098 if you have any questions.

    The proposed changes are provided at this website:

    http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html

    If you are interested in browsing the comments that have already been submitted, go to:

    http://www.regulations.gov/#!home and type HHS-OPHS-2011-0005 in the “Keyword” box.
  • eNews re: IRB Review, August 26, 2011 - Conditional Approval Policy Change and Document Updates

    Aug 26, 2011 at 12:05pm

    Conditional Approval Policy Change

    In the past, the University allowed the release of federal grant funds for human subjects research as soon as conditional IRB approval was granted.  Recently, federal agencies have clarified to OSP and HSD that this practice is not consistent with federal requirements (45 CFR 46.103(b)). 

    Read the online eNews for detailed information.

     

    New and Revised Documents

    HSD has been releasing new or revised written policy, procedure and guidance documents at a brisk pace during the past year.  Please read the eNews online for detailed information about changes for August, and see the new format for delivering this information.

     

     

     

  • Document Update: Suspension or Termination of IRB Approval (#1295)

    Aug 12, 2011 at 12:27pm

    A revised policy/procedure for Suspensions and Terminations has been developed that replaces two documents, (Procedure: Suspension and Termination of IRB Approval #315 and Policy: Suspension and Termination of IRB Approval #314).

    This new procedure combines the policy and procedure and provides additional and more specific information about how this process is handled by the IRB or others authorized to suspend or terminate IRB approval.

    Suspension or Termination of IRB Approval

  • New Policy, Procedure, and Guidance Documents Posted

    Aug 12, 2011 at 12:09pm

    Several new policy, procedure and guidance documents have been posted to the HSD website.  Please see the following list:

    HIPAA:

     

    Human Subject Definition

    Over-enrollment

    Translation and Interpretation

     

    More information will follow in the coming weeks.

     

     

  • eNews re: IRB Review, August 10, 2011 - Proposed Major Revision of Federal Human Subjects Regulations

    Aug 11, 2011 at 4:21pm

    An announcement from HSD regarding the proposed major revision of federal human subjects regulations.

    The Office of Human Research Protections (OHRP) issued an Advance Notice of Proposed Rule Making (ANPRM) for revisions to the rules protecting human research subjects.  HSD is soliciting comments from the campus community by September 10th.

    For more information, please read the newsletter in its entirety online by clicking here.

  • Document Updates: Modification Form (#325), Status Report (#342), Human Subjects Review Application Instructions (#1309)

    Jul 29, 2011 at 12:44pm

    Several minor updates have been made to HSD forms as listed below:

     

    Please contact hsdforms@uw.edu with any questions or comments.

     

  • eNews re: IRB Review, July 28, 2011 - Introducing Limited Activities Determination

    Jul 29, 2011 at 12:36pm

    An important announcement from HSD regarding the replacement of Approval in Principle with the new Limited Activities Determination (LAD).

    Effective immediately, HSD is replacing Approval in Principle with an easier but more restricted process called Limited Activities Determination (LAD). Far fewer grants will qualify for LAD status than qualified for Approval in Principle.

    Please read the newsletter in its entirety online by clicking here.

  • eNews re: IRB Review, July 18, 2011

    Jul 19, 2011 at 7:50am

    A special edition for UW researchers who do industry sponsored studies that are reviewed by Western IRB (WIRB).

    • Comparing the contract, budget, and consent form
    • When should the UW/WIRB Cover Sheet Packet be submitted to HSD?
    • Mandatory Revisions to UW/WIRB Consent Form Template
    Read the newsletter online by clicking here.

  • HSD Performance Metrics: 10th Report Posted

    Jul 8, 2011 at 11:01am

    The 10th Report of HSD Performance Metrics (for reporting period 10/1/10 to 3/31/11) 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/1296 along with reports from previous quarters.

  • Minor Changes to HSD Forms

    May 27, 2011 at 11:38am

    Multiple, minor changes have been made to HSD forms, as appropriate to the individual document. These changes include:

    • HSD now accepts 2-sided copies!
      All HSD forms have been updated to include instructions regarding acceptance of 2-sided submissions.
    • Training requirements in the protection of human research subjects (PHRS) and reporting instructions included.
    • Request for ARRA funding information removed.
    • A separate instructions page has been added to the front of the
      Human Subjects Review Application: UW 13-11.
      This involves no change for researchers.

    Please direct any questions about these changes to hsdforms@uw.edu.

  • New Policy, Procedure, & Guidance: PHRS Training Requirements & Reporting

    May 27, 2011 at 8:20am

    New policy and procedure are available regarding "Training for Researchers, Research Staff, and Consultants in the Protection of Human Research Subjects (PHRS)."

    The Policy states that:

    Individuals who are engaged in research that involves human subjects must complete training in the Protection of Human Research Subjects (PHRS), according to the requirements of the research sponsor.  Sponsors with mandatory training requirements include: the National Institutes of Health (NIH), the Department of Defense (DoD) and its components, and other funding agencies and organizations as described in the grant requirements and/or award.  In addition, the UW Institutional Review Board (IRB) or the Human Subjects Division (HSD) may require researchers to complete PHRS training in response to:

    • compliance concerns,
    • potential risks to subjects, or
    • concerns regarding the ethical and safe conduct of the research.

    Researchers are responsible for reporting training completion to the Human Subjects Division, as described in the Procedure below. 

    All who are engaged in research that involves human subjects are encouraged to complete a "Basic" course in the Protection of Human Research Subjects.

    The Procedure provides detailed information and instructions regarding:

    1. Training Requirements in the Protection of Human Research Subjects (PHRS)
    2. Reporting Completion of PHRS Training to the Human Subjects Division (HSD)
    3. Reporting Completion of PHRS Training to the Office of Sponsored Programs (OSP) and Sponsors or Collaborating Institutions.

    The Guidance on NIH Senior/Key Personnel & Other Significant Contributors provides definitions and guidance, as these terms are related to PHRS training requirements.

    Please direct any questions about these new PPGs to hsdtrain@uw.edu.

  • New Language for Federal Certificates of Confidentiality

    Apr 8, 2011 at 9:58am

    The Human Subjects Division is working to make the required consent form template language meet the lowest reading level possible.  Our goal is for consent forms to read at an 8th grade level.  This is the reading level suggested for the general population of the Seattle area.

    In our efforts to meet this goal we have revised the text researchers must use to explain the protections offered to subjects when a study has a federal Certificate of Confidentiality.  This new text can be found on the HSD website in the following document:

    Certificate of Confidentiality Application Instructions
    http://www.washington.edu/research/hsd/docs/253

    There is no requirement to immediately revise your consent form(s) to this new language if you already are using the previously approved text.  However, we suggest that you revise the text if you are making other consent form changes.  Subjects do not have to be re-consented to the next text.

    Please direct any questions about this to your committee administrative team.

  • PHRS Training Requirement & Options

    Apr 8, 2011 at 9:53am

    Information about Training Requirements and Training Options in the Protection of Human Research Subjects has been updated on the HSD website. There is no change to either the requirements or the options that can be used to meet those requirements. The goal is for the information to be clearer, more complete, and accessible. Instructions have also been included to facilitate verification and reporting of training completion to the Human Subjects Division. We encourage researchers and research staff to review this information and the contact hsdtrain@uw.edu if you have questions.

  • PDF Form Available for Beta-Testing - Initial Application: Exempt Status Request

    Mar 25, 2011 at 2:25pm
    A PDF version of the revised Initial Application: Exempt Status Request is now available for beta-testing of this format. The PDF version incorporates guidance into the document to facilitate researcher access to information when needed during completion of the form. A separate guidance document is also available, as a reference and resource to researchers - who are encouraged to make use of the information in the guidance, before and during application preparation. Users who encounter any problems with the PDF version, or who have questions or suggestions, are encouraged to email hsdforms@uw.edu to request assistance or provide input. The Word version of the form will remain available for use during beta-testing of the PDF version. Thank you to campus - researchers, research staff, and others for your assistance through the development and revision process of this form.
  • Now Available - Research Non-Compliance: Researcher Overview

    Mar 25, 2011 at 2:21pm
    HSD has developed a new policy and procedure to formally describe to researchers the process by which problems that occur in their research projects (which may or may not represent non-compliance) will be handled by HSD staff and the IRB. An accompanying document, Research Non-Compliance: Researcher Overview, includes HSD's policy, definitions of non-compliance, and clarifications about the timeframe (10 days) for required reporting of research problems to the IRB. Consistent with current practice, problems that occur in research will continue to be reported to the IRB using the Report of Other Problems (ROOP) form. The ROOP is used to report events such as protocol deviations or violations, which are types of non-compliance, as well as unanticipated problems. The Research Non-Compliance: Researcher Overview provides important information about how these reports are assessed by HSD staff and the IRB and how the assessment will be communicated to the researcher. A new instruction included in the procedure is . . . Problems/events that occur in research that are out of the control of the researcher/staff do not need to be reported to the IRB unless that problem/event posed an increased risk to the subject(s). You may still be required to report these events to your study sponsor or others. Examples of events out of the control of the researcher/staff include but are not limited to:
    • A lab losing a blood sample IF this lost sample did not pose a risk to the subject’s safety or well-being.
    • A subject who fails to come in for their required study visit by the specified time because their car wouldn’t start if the missed visit did not pose a risk to the subject’s safety or well-being.
    Please note that, also consistent with current practice, adverse events (i.e. reports of actual or potential physical injury/harm to a subject or others) will continue to be reported using the Adverse Event form. Please direct any questions about the new policy and procedure to wbrown3@uw.edu.
  • New UW Policy - National Science Foundation and the Timing of IRB Applications

    Mar 25, 2011 at 2:15pm

    Effective:   March 15, 2011

    The UW Office of Sponsored Programs (OSP) has confirmed with the National Science Foundation (NSF) that institutions may decide that they will operate on a “Just-in-Time” basis for NSF grant proposals.  The UW Office of Research has decide to adopt a Just-in-Time policy for NSF grant proposals, effective immediately.  Note that the Just-in-Time policy already applies to NIH grant proposals.

    What is Just-in-Time?
    This means that researchers do not need to submit an IRB application at the same time they submit a grant proposal.  Instead, they submit their IRB applications as soon as the grant proposal appears likely to be funded.  The funding agencies release the funds when the researcher has received IRB approval.

    What is the advantage of Just-in-Time?
    Researchers will not have had to prepare IRB applications for grant proposals that are not funded.

    How should researchers answer the IRB approval question on NSF grant proposals?
    Select PENDING.   This has been confirmed with NSF.

    How should researchers fill out the eGC1?
    If the grant proposal involves human subjects, check YES on the human subjects question. Then check YES on the Just-in-Time box.

    How do researchers know when to submit the IRB application?
    The OSP system will automatically send an email to the researcher five months after a NSF or NIH grant proposal has been submitted. The email reminds the researcher that IRB approval will be required before grant funds can be released and that the researcher should submit an IRB application soon, or when the researcher believes that the grant proposal is likely to be funded.

    What else should researchers know about this new policy?
    Researchers do not receive a priority score for NSF grant proposals during the grant review process (unlike the NIH review process).  This means that there is likely to be little time between the date when a researcher learns that a NSF grant proposal is being funded and the date when NSF expects the IRB approval.  Though the IRBs do the best they can in these situations, it is the researcher’s responsibility to ensure that there is sufficient time for the IRB to review and approve an application.  The Approval in Principle mechanism cannot be used to address funding agency IRB requirements, except in rare circumstances.

  • HSD Performance Metrics: 9th Report Posted

    Mar 10, 2011 at 10:39am
    The 9th Report of HSD Performance Metrics (for reporting period 7/1/10 to 12/31/10) 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/1243 along with reports from previous quarters.
  • Available: Substantially Revised Form for Exempt Research

    Feb 25, 2011 at 1:22pm

    A substantially revised form with new guidance for exempt research determinations titled: "Initial IRB Application: Exempt Status Request" is now available. These replace the old "Certificate of Exemption" form and instructions.

    HSD will no longer refer to the status of Exemption in the form of a "certificate." Upon determination by HSD that proposed research activities qualify for exempt status, a letter will be sent to the Lead Researcher/Principal Investigator with a determination of Exempt Status.

    Department Chairs, or designees, will be required to sign the Initial IRB Application: Exempt Status Request, as is consistent with all initial IRB applications, before the completed form is sent to the Human Subjects Division. The date of exempt status is the date on which HSD staff make the determination that the research qualifies as exempt, which will be designated in the letter to the Lead Researcher/Principal Investigator.

    The deployment of a revised Initial IRB Application: Exempt Status Request will be a 3-step process:

    Step 1 - Friday, 2/25/2011 - the Initial IRB Application: Exempt Status Request will be available as a Word document with accompanying guidance.

    Step 2 - Friday, 3/25/2011 - a PDF version of the revised form will be made available for beta-testing of this format, which incorporates the guidance into the document.

    Step 3 - Friday, 4/29/2011 (target date) - a finalized PDF form, with incorporated guidance, will be made available.

    This revised form in Word format is available on the HSD website:

    http://www.washington.edu/research/hsd/docs/1207

    and should be used in direct conjunction with the guidance:

    http://www.washington.edu/research/hsd/docs/1206

    As of April 1, 2011, HSD will no longer accept the old "Certificate of Exemption" form.

    Please direct any questions about the form to hsdforms@uw.edu.


    Q&A sessions have been scheduled during March.
    Please sign-up for a session at a time and location convenient to you.
    Be sure to click on "My Enrollment."
  • Document Update: Public Data Sets Policy and Procedure (#T-1125) replaces two documents

    Jan 28, 2011 at 11:00am

    The new document Public Data Sets Policy and Procedure replaces two documents: Public Data Sets Policy (#T-329) and Public Data Sets Procedure (#T-331).

    Policy and procedure have been streamlined into one document.

  • Document Update: Appeal of IRB Determination Policy and Procedure (#I-1120) replaces three documents

    Jan 28, 2011 at 9:49am

    The document Appeal of IRB Determination Policy and Procedure (#I-1120) has replaced three documents: Appeal of IRB Determination Policy (#I-160); Appeal of IRB Determination Proceedure (#I-293); and Appeal of IRB Determination Form (#I-129).

    The appeal policy and procedure have been streamlined into one document, and the need for the the appeal form has been eliminated.

  • Two-Sided Copies

    Jan 11, 2011 at 10:14am

    HSD has received many questions about its policy requiring one-sided copies of all IRB applications and materials.  The policy is currently undergoing review, in light of the University's mandate to re-program most campus printers to automatic two-sided copying and printing.  This issue has significant implications for some internal procedures and staff requirements at HSD and the IRBs.   Watch for an announcement sometime in the next several weeks.

  • Faster WIRB Review Time

    Jan 11, 2011 at 10:12am

    UW clinical trials that are industry-sponsored and industry-initiated are reviewed for the UW by Western IRB (WIRB).

    Two changes implemented in December will result in significantly faster IRB review by WIRB.

    1. The three-day "hold" requirement has been lifted.   This means that study documents approved by WIRB will no longer be held for HSD inspection before being released to the research team and the study sponsor.   The hold is no longer necessary because of the changes in the WIRB submission process that were implemented in August.
    2. The reading level requirement for consent forms has been changed.  Until now, consent forms were required to be written at no more than an 8th grade reading level.   WIRB's standard policy is that consent forms should be written at an 8th- 10thgrade reading level.   WIRB's procedures to address this specific UW requirement added a minimum of 5 days to review time, and sometimes as much as a couple of weeks.   The UW has now changed its reading level requirement for WIRB-reviewed studies to make WIRB's standard policy.
  • Beta-Testing: New IRB Application for Exempt Research

    Dec 22, 2010 at 2:19pm

    HSD has begun beta-testing the new IRB Initial Application: Request for Determination of Exempt Status. The form, guidance, and link to the online survey are available here: Beta Test - New IRB Application for Exempt Research.

    UW researchers, both faculty and students, are welcome to participate in the beta-testing and use the test form and guidance, OR continue to use the existing Certificate of Exemption form. 

    Participants in the beta-testing will:

    • Complete the test form.
    • Submit the test form for review under the current process for exempt research.
    • Complete an online survey to provide feedback about the test form and guidance.
     

    Highlights of the new form include an extensive revision of the general questions, as well as the inclusion of exempt category-specific questions.  A robust guidance document has also been created to guide researchers through the exempt determination process.

    Comments or questions can be directed to hsdforms@uw.edu.

     
  • Case Reports

    Dec 6, 2010 at 1:56pm

    We are happy to announce the release of two new long-awaited tools that will assist researchers who do case reports.  These tools are based on a recently completed analysis and revision of HSD's unwritten policy and procedures about case reports, performed in coordination with UW Medicine's HIPAA Privacy Office. Together these tools provide a written description of the policies and procedures on this topic.

    A case report is information collected and presented on one or more individuals to highlight an interesting experience, observation, treatment, presentation, relationship, or outcome.  It typically (but not always) results from a retrospective review of the individual's record. This is different from a case study, which typically involves a prospective intervention or prospective collection of specimens or data that is not part of standard service or care.

    Tool #1:   Case Report - IRB and HIPAA Requirements

    Researchers can use this one-page decision tree to self-identify any HIPAA and IRB requirements that apply to a specific case report.  It also provides brief information on how to fulfill those requirements, and a definition of "case report".

    Tool #2:   Case Report Research Self-Determination

    The primary IRB issue is whether the case report meets the definition of research provided in federal human subjects regulations.   If it does not, then IRB review is not required.   Researchers can answer the three short questions on this form to self-determine whether IRB review of a specific case report is required.  The form should be completed and kept with the researcher's other records about the case report.   It does not need to be submitted to the Human Subjects Division in most cases.

    We welcome any questions or comments you may have; please send them to hsdinfo@uw.edu.

  • New section in consent form

    Dec 6, 2010 at 1:52pm

    Implementation date:  1-1-11

    Purpose.

    The purpose of the new section is to implement the new policy about significant financial interest (see announcement on SFI Policy).

    Description.

    A new section called Financial Interest has been added to the UW Consent Form Template.  It is required when any member of the research team has a significant financial interest, as defined by UW Policy GIM 10.  If no one has a significant financial interest, the section may be omitted.   The consent form must disclose of the existence of a significant financial interest but not the monetary value of the financial interest.  The consent template provides short descriptive language to use for specific types of financial interest.

    New research.

    All consent forms approved after December 31, 2010 must have this new section, if applicable.

    Existing research.

    The Financial Interest section must be added to the already-approved consent forms of ongoing research, if applicable.  This may be done at any time (such as when a Modification is being submitted for another purpose) but will be required at the time of the next Status Report if the issue has not already been addressed.   In some cases, the IRB may contact the research team and require the consent form revision before the next Status Report.   Though this revision will generally not require re-consenting of already-enrolled subjects who are still actively participating in a study, the IRB will use its judgment to determine whether the financial interest information should be communicated to such subjects. 

    Questions?  Consult hsdinfo@uw.edu or one of HSD's IRB Administrators.

  • UW IRB policy about significant financial interest

    Dec 6, 2010 at 1:47pm

    Implementation date:  12-2-10

    A new policy and procedure is being implemented to address significant financial interests in research, as defined by UW Policy GIM 10,  and other possible types of research conflicts of interest.  The policy and procedure are posted on the HSD website, as a document entitled "Researcher Conflict of Interest."

    The policy statement is:

    Researchers are required to disclose to the IRB any potential conflict of interest with respect to a human subjects research activity, including any significant financial interest.  A significant financial interest of any member of the research team shall be disclosed to the subjects through the consent process, unless consent is not required (exempt research) or has been waived by the IRB.  For research that uses a consent form, the disclosure requirement is fulfilled by the Financial Interest section of the consent form (for all consent forms approved after December 31, 2010).

    The requirements of a Significant Financial Interest (SFI) Management Plan from the UW Office of Research shall be incorporated into the research before the IRB can grant full unconditional approval or HSD can grant exempt status for the research.  The IRB or HSD may impose additional requirements to mitigate or manage financial or other potential conflict of interest if it feels that the researcher's plans and the SFI Management Plan are not sufficient.  This policy applies to all human subjects research activities, regardless of level of IRB review, type of research, or source of funding.

  • HSD Performance Metrics: 8th Report Posted

    Nov 16, 2010 at 1:49pm

    The 8th Report of HSD Performance Metrics (for reporting period 4/1/10 to 9/30/10) 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/1151 along with reports from previous quarters.

  • Document Update: IRB Conflict of Interest (F-503)

    Nov 1, 2010 at 2:22pm

    Minor revisions have been made to the IRB Conflict of Interest guidance to clarify the scope and details regarding IRB members, Human Subjects Division staff, and IRB consultants in the potential conflict of interest in review of research.

  • Review Turnaround Time for Minimal Risk IRB Applications

    Oct 21, 2010 at 2:13pm

    Turnaround time for the review and approval of Minimal Risk IRB Applications is likely to be somewhat longer than usual during Autumn Quarter, 2010.  We recommend that you allow 6-8 weeks for obtaining approval of Minimal Risk applications

    With the start of the new academic year, many students and faculty start to plan new research projects.  For projects involving human subjects, it is important to allow sufficient time for the mandatory Institutional Review Board (IRB) review and approval process.  This must be completed before beginning the research.

    The median turnaround time for receiving, reviewing, and approving applications was 19 business days (about 4 weeks) for our most recent reporting period, with a range of 0-248 business days.  This includes the time at HSD as well as the time taken by a researcher to respond to questions or reviews.

    HSD's Minimal Risk team has been experiencing a steadily increasing workload during the past several months.  In addition, some positions on the team have been recently filled with new individuals or are vacant.  During this personnel transition period, we expect that Minimal Risk reviews will take somewhat longer.   We ask for your patience, and we assure you that we are continuing to look at various possibilities for making our process more efficient.

     

  • UW Researchers who are members of the Cancer Consortium

    Oct 21, 2010 at 2:11pm

    Reminder:   All human subjects research that is cancer-related and for which the principal investigator is a member of the Cancer Consortium must be reviewed by the Fred Hutchinson CC-IRB instead of the UW IRB.   There are two exceptions:

    • Repositories that are physically kept in UW owned, operated, or leased facilities.
    • Industry-initiated-and-sponsored clinical trials. (Investigators can chose whether to have these reviewed by the Hutch's CC-IRB or by WIRB.)

    This arrangement between the UW and the Hutch began in 2005, to ensure that the IRB review of cancer-related studies is performed by individuals who have oncology experience and expertise.

    New IRB applications.  Unless your research qualifies for one of the exceptions above, you must submit any new IRB applications to the Fred Hutch IRB, using the Fred Hutch IRB application. We have noticed recently that UW investigators who are new members of the Cancer Consortium are not consistently aware of this requirement. We have unfortunately received several applications to the UW IRB which we had to return, with the request that the investigator complete the Fred Hutch IRB application instead.

    Existing IRB applications with the UW IRB.   When someone becomes a member of the Cancer Consortium, any existing IRB applications will be transferred to the CC-IRB about 12 weeks before expiration of IRB approval. The UW IRB and/or the CC-IRB will contact the investigators well in advance.

    Exceptions to transfer from the UW to CC-IRB include:

    • Repositories (as described above)
    • Studies for which subject enrollment has been completed
    • Studies with exempt status.

    If you have any questions, please contact Arna Elezovic at hsdinfo@u.washington.edu or 543-0639.

  • HSD Invites the UW Research Community to Attend a Webinar on The Guatemalan Inoculation Study (10/20)

    Oct 15, 2010 at 7:44am

    Join HSD Staff & IRB Members for a Webinar & Discussion . . .

    The Guatemalan Inoculation Study:
    Susan M. Reverby on Research Ethics and Lessons for Human Research Protection Programs

    HSD has arranged for participation by the UW research community in this webinar conducted by the organization Public Responsibility in Medicine & Research (PRIM&R).

    Please join HSD staff and IRB members for this session and discussion on:

    Wednesday, October 20 at 10:00 AM

    Location #1: Health Sciences Building - Room T-733 (capacity 100)

    Location #2: Gates Hall - Room 115 (capacity 45)

    About the Webinar:

    The Guatemala syphilis study, conducted more than 60 years ago and recently unearthed by medical historian Susan M. Reverby, is another shocking, and sadly familiar example of the abuse of human subjects in research.

    Ms. Reverby will present her findings during the webinar, which will cover the horrific story of US public health researchers intentionally infecting hundreds of people in Guatemala with gonorrhea and syphilis without their knowledge. Lessons for today's Human Research Protection Program professionals, researchers, and research staff will also be discussed.

    Readings on the study and issues:

    A draft "pre-print" of Dr. Reverby's main article on this Guatemalan situation is available on her Wellesley home webpage: http://www.wellesley.edu/WomenSt/Reverby%20Normal%20Exposure.pdf

    An early release article from JAMA (posted 10/11/10) - Intentional Infection of Vulnerable Populations in 1946-1948: Another Tragic History Lesson http://jama.ama-assn.org/cgi/content/full/jama.2010.1554?eaf

     

    No registration is needed and there is no cost to attend the session. Space in T-733 is limited to 100 and in Gates Hall Room 115 is 45.

  • HSD’s New Website – Live!

    Sep 13, 2010 at 7:40am

    The Human Subjects Division's new website has gone live and is available for use.

    A few things about the new site:

    • It's at the same url as the old site: www.washington.edu/research/hsd (so your bookmark in Favorites will still take you to the right place).
    • Document links have changed. Each document has a "landing page." Links to a landing page or to a document can be saved to a user's favorites.
    • Page links within the site are different - so, please explore the site and bookmark links as makes sense for your use.

    If you experience any difficulty accessing the site or finding what you're looking for - please contact HSD at hsdweb@uw.edu.

    Our thanks to those on campus who participated as testers during development - your input was invaluable!

     

  • HSD Performance Metrics: 7th Report Posted

    Sep 7, 2010 at 9:50am
    The 7th Report of HSD Performance Metrics (for reporting period 1/1/10 to 6/30/10) 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/topics/HSD+metrics, along with reports from previous quarters.
  • New Guidance and Form: Use of Non-Identifiable Specimens/Data (#I-308, #I-295)

    Sep 3, 2010 at 10:16am
    New Guidance and Form for the "Use of Non-Identifiable Specimens/Data" have been posted.  This guidance and form will replace the previous Biological Specimens Review Determination form and Biological Specimens Guidance. The purpose of this guidance and form is to determine whether human subjects are involved in research that consists of obtaining private information (data) and/or biological specimens, according to federal, state, and University of Washington definitions.  If not, the project requires neither Certification of Exemption nor IRB review. The guidance and form represent a revised understanding of relevant federal and state regulations and clarifies when the use of human specimens and/or data does, or does not, need IRB review.
  • New Guidance and Form: GWAS dbGaP General Guidance and Supplemental Form (#P-932, #I-933)

    Sep 3, 2010 at 9:16am

    HSD Guidance and Forms for UW researchers for submission to and request data from the NIH database of Genotypes and Phenotypes (dbGaP) are posted. 

    The GWAS dbGaP General Guidance document provides a comprehensive overview of HSD principles relating to the submission of data to dbGaP as well as request for data from dbGaP.  Included in this document are the procedures involved in the process as well as a listing of the forms and documents that are needed for your submission to HSD. 

    The GWAS dbGaP Supplement is the main form for information if you are planning to submit data from your research study to dbGaP.  As well as providing an easy-to-complete checklist for all NIH-required information for submission to dbGaP, the document provides an overview of elements that are needed in your consent documents and sample text that you may use. 

    Please contact Shannon Sewards (ssewards@uw.edu) if you have further questions.

  • New Guidance: Contract and Consent Form Comparison (#I-1079)

    Aug 27, 2010 at 1:57pm

    New guidance is available for industry-sponsored clinical trials reviewed by the UW IRB, WIRB, and the CC-IRB. Document 1079, "Contract and Consent Form Comparison" describes the new contract and consent form comparison process implemented on 8/16/10.

    (Please see the announcement "Change in WIRB Process" published on 8/3/10.)

    Direct link to "Contract and Consent Form Comparison"

  • Document Updates: Report of Other Problems now a stand-alone form (#K-324)

    Aug 17, 2010 at 1:03pm

    An improvement to the Supplemental Form: Report of Other Problems has been made, based on researcher and HSD staff suggestions, effective immediately. The revised Report of Other Problems form is posted and available for use.

     

    The improvement consists of “adding” the first page of the Modification form to the Report of Other Problems form as a cover sheet. Now, the only form a researcher needs to send in to report an event is the Report of Other Problems form (it used to be that the researcher would have to send in the first page of the Modification form AND the Report of Other Problems form).

     

    The Report of Other Problems form will no longer be considered a “supplemental form,” but rather, a STAND-ALONE form. The types of events that researchers are asked to report will remain the same (e.g., protocol deviations, DSMB reports, etc.).

     

    If you have any questions, please contact Andrea Marsden, Compliance Administrator, amarsden@uw.edu.

  • Change in WIRB Process

    Aug 3, 2010 at 8:53am

    Affects:   Industry-initiated clinical trials reviewed by Western IRB (WIRB)

    Effective date:   August 16, 2010

    The industry contract or clinical trial agreement must be completed before HSD will sign the WIRB Cover Sheet that authorizes submission of the IRB application to WIRB.   This will allow HSD to ensure that the contract, consent form, and study budget are consistent in their descriptions of who pays for what procedures and adverse events.   This consistency comparison will be part of the WIRB Cover Sheet signing process.  By changing the timing of this process, HSD expects to eliminate many of the comparison iterations that currently occur for many WIRB-reviewed clinical trials.

     

  • Increased HSD Fee for Clinical Trials

    Aug 3, 2010 at 8:52am

    Affects:   All industry-initiated clinical trials

    Effective date:   All contracts completed on or after September 1, 2010

    The fee charged by HSD to sponsors of industry-initiated clinical trials is increasing from $1000 to $1500.  Since 2003, HSD has charged a $1000 fee to help cover HSD's costs for fulfilling mandatory regulatory and administrative responsibilities that HSD retains regardless of where the IRB review occurs.  This fee has remained unchanged until now, though HSD responsibilities and expenses have increased.   The background and rationale for this increase is provided in a one-page News Release: Increased Fee.

     

  • New Policy: Signatures on IRB Forms

    Jun 16, 2010 at 2:41pm
    The policy of the Human Subjects Division regarding Signatures on IRB Forms has changed, effective June 18, 2010. This change is intended to eliminate requirements and reduce work that provide no clear benefit to compliance or subject protection, while still reaffirming the fundamental responsibilities of those involved in human subjects research. This new policy changes the signature requirements for:
    • Lead Researchers (Principal Investigators)
    • Department Chairs, and
    • Faculty Sponsors (of student research).
      These individuals, their staff, and designees are advised to review the new policy and be prepared to implement the new requirements as of 6/18/2010. The HSD forms that are impacted have been revised to reflect the new policy. A list of the revised forms and the changes made is available at Signature Policy - - Form Changes. Questions, concerns, or recommendations regarding the new policy can be directed to hsdforms@uw.edu.
    • HSD Performance Metrics: 6th Report Posted

      Jun 10, 2010 at 3:31pm
      The 6th Report of HSD Performance Metrics (for reporting period 10/1/09 to 3/31/10) has been posted to the HSD home page.  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/topics/HSD+metrics, along with reports from previous quarters.
    • HIPAA Authorization forms and the UW Clinical Research Center

      Apr 23, 2010 at 10:51am

      The Issue

      The UW Clinical Research Center (CRC) is a unit in the UW Medical Center.  This means that a medical record is created for every subject who comes to the CRC, if the subject does not already have a UW Medicine medical record.  When the CRC staff interact with the subject to obtain research information or conduct any research procedures other than single blood draws, the information from or about those activities goes into the subject's medical record.  When the CRC staff subsequently give the information to the researcher, it is considered to be an access to (and disclosure from) the subject's medical record.   

      Also, the occurrence and treatment of any adverse event that happens on the CRC is entered into the subject's medical record and then disclosed to the researcher.  Examples:  fainting during a blood draw, nausea in response to a study drug, or stumbling while stepping off the weight scale.  When the CRC provides the researcher with information about the event and its treatment, this is again considered to be an access to (and disclosure from) the subject's medical record.

      This means that the CRC needs a signed HIPAA Authorization from each subject.  

      The Process
      The following process will be used to address this compliance and subject confidentiality concern.

      1      IRB application

      A new question has been added to the IRB application.  It asks researchers about their use of the CRC.  If they answer "yes", they are instructed to complete and attach a research HIPAA Authorization form using the template on the HSD Forms webpage. 

      2      HIPAA Authorization template

      Language about the CRC has been added to the end of section B in the UW HIPAA Authorization template.  Researchers who are using the CRC can chose one of two short paragraphs.  One is for studies where CRC staff are collecting research information or conducting research procedures.  The other paragraph option is for studies where the only possible medical records access & disclosure is for information about adverse events that may occur on the CRC.

      3      Institute of Translational Health Sciences (ITHS) Scientific Review Committee (SRC) review  

      The SRC review is the process by which a researcher applies for the use of the CRC and associated core ITHS resources.  It typically occurs several months before a study starts.  The researcher is required to provide a copy of the submitted IRB application, resource utilization forms, and other documents specific to the ITHS.  The CRC staff will compare the answer on the IRB question about the CRC with the information in the resource utilization forms.  This will verify the researcher's assessment about what information the CRC staff are disclosing from subjects' medical records to the researcher.  If necessary, the researcher will be directed to submit a Modification to the IRB, for a revised HIPAA Authorization form.

      4      Protocol Implementation Meeting (PIM) with CRC Nursing Staff

      The PIM meeting occurs just before a study starts.  In this meeting, the researcher and assigned primary CRC Nurse define the roles, responsibilities, and activities of the CRC staff.  This provides yet another opportunity to determine what medical records information is being accessed and disclosed by CRC staff to the researcher.  If necessary, the researcher will be directed to submit a Modification to the IRB, for a revised HIPAA Authorization form.

      This process has been approved by the ITHS Clinical Compliance Officer, Research Subject Advocate and staff of the CRC; the Director of the UW Medicine Privacy Office; and the Director of the Human Subjects Division.

       

    • Launch of the Office of Research iSTAR Web site!

      Apr 20, 2010 at 9:41am

      Message on behalf of Vice Provost Mary Lidstrom
      ------------------------------------------------------------------

      Dear Colleagues:

      As you know, in 2007 the Office of Research launched an organization-wide initiative called iSTAR ("Improving Service to Advance Research"). The anticipated outcomes of these efforts are: to enhance service levels to researchers and their support staff; to increase efficiencies within OR; and to ensure that OR provides a working climate that is respectful and supportive to staff, and offers development and growth opportunities where possible.

      One of the outcomes of this effort is the development of an iSTAR website. This site features our metrics dashboard, training and survey results, and progress/updates to OR's strategic goals through process improvement initiatives. The dashboard measures organization success in the following areas:

      • Customer Service
      • Systems Support
      • Operational Excellence
      • Training

      Please visit our site at: http://www.washington.edu/research/main.php?page=istar
      (The iSTAR page is located off the "About OR" tab on the OR front page.)

      We welcome your feedback. Please email research@u.washington.edu for questions or comments.

      Mary Lidstrom, Vice Provost for Research

    • HSD Performance Metrics: 5th Report Posted

      Apr 20, 2010 at 9:39am
      The 5th Report of HSD Performance Metrics (for reporting period 7/1/09 - 12/31/09) has been posted to the HSD home page. 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/topics/HSD+metrics, along with reports from previous quarters
    • WIRB Fee Schedule Change: Effective 6/1/2010

      Apr 20, 2010 at 9:38am

      Western Institutional Review Board (WIRB) is adjusting its fee schedules effective June 1, 2010. A copy is posted to the HSD Web site at http://www.washington.edu/research/hsd/docs/1038.

      Please be advised that all services provided on or after June 1, 2010, will be billed at the new rates.

      If you have any questions, please contact WIRB's Client Services Department at 360-252-2500 or 1-800-562-4789.

    • Final HIPAA Authorization Form Revisions

      Feb 9, 2010 at 3:46pm

      The final revisions to the UW HIPAA Authorization Form (used for research purposes) have been completed.  The revised form (version 3.2) is now posted.

      Researchers do not need to revise their current HIPAA Authorization form to include these changes.

      The primary changes include:

      • Inclusion of a short paragraph about the need to obtain a minor's signature in order to obtain certain kinds of information about that minor (e.g., information relating to reproductive care).
      • Use of the phrase "patient information" instead of "protected health information", to improve clarity and comprehension
      • Some minor clarification of instructions to researchers - for example, about the Expiration Date
      • Some minor re-organization, to improve clarity

       

    • Important HIPAA Information

      Feb 9, 2010 at 3:44pm

      As mentioned in previous newsletters, the ARRA federal stimulus legislation included many revisions and additions to the HIPAA regulations that govern the use of healthcare records.   The changes include significant increases in the procedures and penalties associated with unauthorized access of healthcare records.

      HSD has recently become aware that researchers may not realize that the following scenarios are considered "unauthorized access" and therefore are noncompliance with the HIPAA regulations and the IRB approval for a study:

      • Accessing more health care records than proposed in your IRB application. 

      Example:   you state in your IRB application that you will review data from 500 medical records, but in fact you review 504 medical records.

      • Accessing health care records after the expiration date on the HIPAA Authorization form signed by subjects.
      • Accessing and recording data for health care provided outside of the time window described in your IRB application.

      Example:  you state in your IRB application that you are accessing and recording all cholesterol results from tests performed on subjects between January 1, 2003 and December 31, 2008, but you also record results for tests performed in 2009.

      The new HIPAA regulations require UW Medicine to notify all individuals whose healthcare records have been subject to unauthorized access, regardless of the number of individuals.

      There are also public reporting requirements (which may including informing the local media) and, as warranted, financial penalties associated with unauthorized access. 

      Please consult with any of the following if you have any questions or concerns:

       

    • NIH-funded Clinical Trials

      Feb 9, 2010 at 3:42pm

      Requirement to register clinical trials.  For the past few years, there has been a federal requirement to register clinical trials, usually with a federal site called ClinicalTrials.gov.   The purpose of the registration requirement is to increase transparency and knowledge about clinical trials and their results.

      The University's institutional liaison and contact point with ClinicalTrials.gov is Arna Elezovic.  She is the clinical trials administrator at the Human Subjects Division.   elezovic@u.washington.edu  206-543-0639

      Recent change in NIH policy.   The National Institutes of Health (NIH) have usually registered the trials that it funds.  However, NIH recently decided that it will no longer perform this service for researchers.  Instead, researchers are now responsible for the registration process.  In addition, NIH has started to ask researchers with ongoing NIH-funded clinical trials to transfer the registration "ownership" from NIH to the researchers themselves.

      Transferring registration "ownership" from NIH to yourself.  Here are the simple instructions for how to transfer registration ownership of your clinical trial from NIH to yourself. 

      1.       Contact your grant's NIH program officer to obtain the following information for your clinical trial:

      • The username used by your NIH program to login to the ClinicalTrials.Gov system when NIH registered your trial
      • The organization name used by your NIH program to register your trial
      • The NCT trial number for your trial

      2.       Gather the following additional information:

      Your NIH grant number (activity code, institute code, and 6 digit serial number)

      Example:  R01AG013131

      3.       Contact Arna Elezovic at the Human Subjects Division.

      She is the UW institutional contact and liaison with the ClinicalTrials.gov system.

      elezovic@u.washington.edu / 206-543-0639

      4.       Set up an investigator (personal) account with the ClinicalTrials.gov system called PRS (Protocol Registration System), following the instructions provided by Arna.   If you already have an investigator account, Arna will provide alternate instructions.

      The website for the ClinicalTrials.gov system is called PRS, where investigators create accounts and register/transfer trials:  http://prsinfo.clinicaltrials.gov  

       

    • IRB Review Fees at Swedish Medical Center

      Feb 9, 2010 at 3:39pm
      The UW IRB has a cooperative agreement with the Swedish Medical Center IRB:   UW researchers who are engaged in research at Swedish may qualify to have their IRB review performed by the Swedish IRB instead of the UW IRB.   The criteria for moving the review to the Swedish IRB are summarized on the HSD website at: https://www.washington.edu/research/hsd/topics/Cooperative+Agreements The Swedish IRB does charge a fee for the review of studies funded by federal grants that do not send indirect costs to Swedish or that are funded by industry.  The fee schedule was revised on January 1, 2010, to the following:
      IRB review, cooperative initial review            $500
      IRB review, cooperative continuing review     $250

      There is no charge for the review of modifications, adverse event reports, or reports of protocol deviations or violations.
    • New Energy Website Launched!

      Jan 29, 2010 at 11:07am

      Energy researchers at the University of Washington are involved in scientific discovery, technology innovation, and society impacts research, and are involved in a broad range of energy projects that are making a difference and changing lives. The new website is designed to build the reputation of the UW in energy research, to increase our visibility, and to serve as a resource to find expertise in a given research area.  Visit Energy Research at the UW.

    • Research involving the Department of Defense

      Nov 25, 2009 at 3:14pm
      Research involving the Department of Defense (DoD) requires additional compliance activities, documentation, and subject protections. Applicability to exempt research.  These requirements apply to all DoD-related human subjects research, including research that qualifies for exempt status (also called a Certificate of Exemption). Definition of DoD involvement.  Research involves the DoD when any of the following apply:
      • The research is funded by a component of DoD. (Example: the Office of Naval Research).
      • The research involves cooperation, collaboration, or other type of agreement with a component of DoD.
      • The research uses property, facilities, or assets of a component of DoD.
      • The subject population will intentionally include personnel (military or civilian) from a component of DoD.
      A DoD Supplement to the IRB application is now posted, to assist researchers and the UW IRB in ensuring that these requirements are met.  Effective immediately, all new IRB applications for research that involves the DoD must include this Supplement as an attachment.  DoD funding:  an additional requirement.  Because of a new DoD regulation implemented this summer, researchers are not allowed to expend DoD funds in connection with a human subjects project until all of the following conditions are met.  Researchers should allow for the extra time this will require.
      • The IRB has reviewed and approved the research (or has granted exempt status).
      • The UW has furnished the DoD component that is funding the research with documentation of IRB approval or exemption.
      • The UW Office of Sponsored Programs has received notice from the DoD component that the UW IRB approval (or exemption) has been received and accepted.
      Guidance and more information.  A guidance document is posted on the HSD Policies & Procedures page, which provides more detailed information about the DoD requirements, the questions on the DoD Supplement form, and funding implications.  Researchers should anticipate and plan for these additional requirements, which may require significant consideration in the budget and research timeline (see guidance document).  
    • Revision to new HIPAA Authorization form template

      Nov 25, 2009 at 3:12pm

      The new HIPAA Authorization form template has been revised in some sections, to incorporate some excellent additional feedback provided by researchers.  The most substantial revision is in the Expiration Date section. Also, references to placing research data into medical records have been deleted, as that information is best communicated to subjects in the consent form rather than the HIPAA authorization form.  There are other, more minor, revisions scattered throughout the form.   If you have already submitted your new HIPAA form to the IRB for review, you do not need to re-do it.

    • Expansion of Minimal Risk Category 5

      Nov 3, 2009 at 8:38am

      Background.  To qualify for "Minimal Risk" review, research must involve no more than minimal risk and it must fit into one of nine categories described by federal human subjects regulations. 

      Category #5 refers to research involving the use of individually-identifiable materials (data, documents, records, or specimens) that are not collected specifically for the researcher's proposed project.  Until now, this category has been restricted to research involving the use of materials that were originally (or will be) collected for non-research purposes.   Example:   the research use of "left over" specimens from clinical procedures.

      Revised policy.  The University of Washington IRB is acting upon a recently published statement from a federal regulatory agency that clarifies the agency's intent for this Category to include existing individually-identifiable materials collected for some other research purpose.  Example:  a researcher's use of residual blood samples already obtained by another researcher as part of a different research study.   The table below depicts this revised policy. 

      This policy is effective immediately.  It means that many research studies will now qualify for Minimal Risk review instead of being reviewed by a full IRB committee.

       

      The materials exist prior to the date when the researcher submits his/her IRB application

      Some/all of the materials will be collected after the researcher submits his/her IRB application

      Materials originally collected for non-research purpose

       

      May qualify for Category 5

       

       

      May qualify for Category 5

      Materials originally collected for some other research purpose

       

      (New)  May qualify for Category 5

       

       

      Does not qualify for Category 5

       

    • Revised HIPAA Authorization Form

      Nov 3, 2009 at 8:37am
      A significantly revised HIPAA Authorization Form is now posted and implemented.  The purpose of the revisions is to:
      • Ensure that all required elements of HIPAA Authorization are present and clearly stated.
      • Clarify that the form may be used by parents or other legally-authorized representatives for health information of children subjects or other subjects who are not capable of providing authorization.
      • Allow for some customization of the form, to better fit a wide variety of research.
      All new IRB applications submitted on or after December 1, 2009 must use this revised version, if HIPAA Authorization is being obtained as part of the research. For already-approved studies that are still enrolling subjects:   the HIPAA Authorization form must be replaced with this revised version at the time of the next Modification or Status Report, beginning on December 1, 2009.  However, researchers do not need to wait until this time, if they wish to replace their current HIPAA Authorization forms more quickly. Previously enrolled subjects do not need to sign a new HIPAA Authorization Form.
    • Requests for Waivers of Consent or HIPAA Authorization

      Nov 3, 2009 at 8:35am

      Background.  One common issue in "back and forth" communications between researchers and the IRB is the IRB's need for information that justifies a researcher's request for a waiver of consent, waiver of documentation of consent, and/or waiver of HIPAA authorization.   The IRB is required to establish and document that the federally-mandated criteria for granting these waivers have been met.

      New requirement.  Effectively immediately, the basic IRB application (form 13-11) now asks researchers to attach a new form that addresses these criteria.  These forms are entitled Waiver Request: Consent and Waiver Request: HIPAA Authorization.  The goal of creating these new forms is to reduce some  "back and forth" communication and to provide a consistent method of documenting the waivers that complies with federal regulatory requirements.

      Why create new forms?  Why not just add questions to the existing application?   Many researchers do not need a waiver of consent or HIPAA authorization, and adding these questions to the existing application form would lengthen the form by several pages.

    • Changes to the HIPAA Regulations about Health Care Records

      Nov 3, 2009 at 8:32am

      New requirement.  Effective September 23, 2009, the American Recovery and Reinvestment Act (ARRA) added a new requirement to the HIPAA regulations about protected health care information (such as medical records).  UW Medicine is now required to inform patients or research subjects when their medical records are inappropriately accessed by UW workforce members (including UW researchers).  Prior to this time, patients and subjects have been notified about inappropriate disclosures.  Reporting inappropriate accesses is a significant change. 

      There can be stiff federally-imposed penalties for failing to comply with this new addition to the HIPAA regulations, or for failing to report the discovery of an inappropriate access. 

      Compliance audits.  Each access to a UW on-line medical record is electronically recorded and may be audited to verify that the access is appropriate.  The UW Medicine Privacy Program does 40 random audits every week to verify appropriate access.  This is in addition to a variable number of focused audits that are directed toward a specific member or segment of the UW workforce, or toward a specific patient or patient population.

      More HIPAA changes are coming.  Though most researchers think of ARRA as the federal "stimulus funding" legislation, the ARRA also includes many significant additions or revisions to the HIPAA regulations.  HSD will inform campus researchers about each of these changes, and their impact, as the implementation date for a given change draws near.

    • Revised HIV Consent Form Template

      Nov 3, 2009 at 8:30am

      It is UW IRB policy to generally require a separate HIV consent form when subjects are tested for HIV/AIDS as part of a research study.  Note:  "generally" means that there is some flexibility in this policy for consideration of specific circumstances and history.

      The UW HIV consent form template has been revised.  The purpose of these revisions is to ensure that this consent template accurately reflects:

      • Significant changes made in the past several years in Washington State laws about HIV/AIDS testing.
      • Significant changes in the health insurance industry with respect with HIV/AIDS.
      • Significant changes in the general perception of, and reaction to, HIV/AIDS.

      All new IRB applications submitted on or after December 1, 2009 should use this revised HIV consent template if a separate HIV/AIDS consent form is being used.  HSD recognizes that some long-standing research groups have developed their own HIV/AIDS consent form; those forms may continue to be used with future research as long as they are consistent with the information in the revised HSD template.

      For already-approved studies that are still enrolling subjects:  Existing HIV consent forms should be compared with this revised version, to identify any information content that should be changed.  Also, the IRB may require some changes when it reviews a study's Status Report or a Modification.

    • Notice: Deadline for Registering with ClinicalTrials.gov

      Sep 22, 2009 at 12:19pm
      As of September 27, 2009, researchers of applicable clinical trials are required to register their results, including adverse events, with ClinicalTrials.gov. Please see Registering Results with ClinicalTrials.gov for more information. Further Resources: Progress and Deficiencies in the Registration of Clinical Trials Alastair J.J. Wood, M.D. New England Journal of Medicine Volume 360:824-830, February 19, 2009, Number 8 Reporting "Basic Results" in ClinicalTrials.gov Tony Tse, Rebecca J. Williams and Deborah A. Zarin CHEST Volume 136;295-303, July 2009, Number 1

      [Note: Links to full articles are available to UW faculty, staff and students when using a computer with a UW IP address, or by logging into the UW Libraries off-campus access.]

    • IRB Records: Access and Copying for Researchers

      Jul 8, 2009 at 1:27pm
      The Human Subjects Division often receives requests from researchers for copies of IRB documents that are missing from the researcher's file.  Unfortunately, we will generally no longer be able to fulfill these requests, effective immediately. It is the researcher's responsibility, per federal regulations, to maintain a file of all documents relevant to IRB review throughout a research study and for at least three years after the study is closed.  The records should be a mirror image of the IRB's records, which means:  (1) all documents submitted by the researcher to HSD and the IRB, and (2) all correspondence between the researcher, HSD, and the IRB.  The IRB files at HSD are official University records and are required by federal regulations governing human subjects research.  Their integrity must be maintained at all times.  This means that individuals outside of HSD, the IRB, and compliance groups cannot be allowed unmonitored access to the files.  Due to staff time constraints, HSD staff are not available to assist researchers in comparing their files with the official IRB files.  We understand that there are unavoidable circumstances when an IRB document may be needed.  If this should occur, a request for copies may be fulfilled only if the researcher or designee provides HSD staff with sufficient written justification.