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Human Subjects Division (HSD)

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  • 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.

     

  • Mary Lidstrom Received ARPA-E Award of $4 million for “Biocatalyst for Small-Scale Conversion of Natural Gas into Diesel Fuel”

    Dec 6, 2012 at 3:25pm

    DOE’s ARPA-E awards have been announced, and one of the recipients is the University of Washington team led by Mary Lidstrom, Vice Provost for Research and Professor in Chemical Engineering and Microbiology. Sixty-six projects were awarded $130 million for projects that, “…seeks out transformational, breakthrough technologies that show fundamental technical promise but are too early for private-sector investment. These projects have the potential to produce game-changing breakthroughs in energy technology, form the foundation for entirely new industries, and have large commercial impacts.” The awards support Obama’s goals of, “…solving our nation’s most pressing energy challenges.” Lidstrom’s project description is below.

    Biocatalyst for Small-Scale Conversion of Natural Gas into Diesel Fuel

    The University of Washington will develop microbes that convert methane found in natural gas into liquid diesel fuel. These microbes enable small-scale gas-to-liquid conversion at lower cost than current methods, which require infrastructure that is too expensive to deploy at smaller scales. Small-scale conversion would leverage abundant, domestic natural gas resources and reduce U.S. dependence on foreign oil.

  • 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!

  • New Online Training for Process Improvement

    Jul 30, 2012 at 7:05am

    OEI has partnered with the Institute of Translational Health Sciences to develop online training for Organizational Effectiveness tools.   This modular training includes an overview of continuous improvement, and introductions to various tools on problem solving, decision making, visual management and more. To request an invitation to the training, please send OEI (oei@uw.edu) your full name and UW email address. You will receive an email with the invitation to join the course from Training Xchange. Please create an account to access the training. As a UW faculty, staff or student, you will have access to all the current modules free of charge.

    This project was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant 3UL1RR025014.

  • 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.

  • Free Statistical Consulting Services Offered by the Departments of Biostatistics and Statistics

    Jun 18, 2012 at 7:03am

    Graduate students and faculty in the Consulting Program of the Departments of Biostatistics and Statistics offer free statistical advice to UW faculty, staff and students.  Through 50 minute consulting appointments, the consulting program provides assistance with:

    • design of studies and experiments, including preparation of grant proposals
    • data visualization and presentation
    •  choice and application of statistical methods
    •  development of specialized statistical methods

    Consulting appointments can be scheduled during  academic quarters, including summer quarter. To schedule an appointment, contact the departments of Biostatistics (616-6790, bconslt@u.washington.edu) or Statistics (543-7273, sconslt@stat.washington.edu). Researchers may schedule appointments in either department.  See www.stat.washington.edu/consulting, where there are links to an appointment calendar and  an online  Problem Description Form  required for all new appointments.

    Consultants can provide free assistance with some data analysis projects, but extensive hands-on assistance with data analysis is not available without funding. This service does not provide software training.  Fee-based collaborative consulting is available through the Center for Statistical Consulting (www.stat.washington.edu/consulting/csc.html) or the Center for Biomedical Statistics (depts.washington.edu/medstat).

  • 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.

  • Coming this Summer: New Financial Conflicts of Interest Regulations

    May 25, 2012 at 12:36pm

    The University of Washington’s policy on Financial Conflict of Interest (FCOI) will be revised to comply with the Public Health Service (PHS) FCOI regulations which go into effect on August 24, 2012. UW investigators must continue to follow the current UW’s SFI Disclosure Policy (GIM-10) until otherwise informed.

    The Office of Research is developing implementation processes and throughout the summer will post frequent updates on the new FCOI Web site

  • 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.]

    • URGENT: SHORT-TERM TRIAGE POLICY

      Sep 22, 2009 at 8:29am

      The Human Subjects Division (HSD) and the UW Institutional Review Board (IRB) have received a flood of new applications and modification requests associated with ARRA funding (also called federal stimulus funding).   This is expected to continue for several weeks.  In addition, we are starting to receive urgent applications associated with the end of the federal fiscal year and the funding that federal sponsors must have awarded by October 1 (the end of the federal fiscal year).

      This is occurring at a time when we have some vacant key positions, a new IRB committee that is still coming up to speed, continuing fall-out from our separation from the Seattle VA, and an expectation that the H1N1 flu will soon start to circulate on campus (including our office).

      In sum, we are facing a temporary but extraordinary workload situation for the next 4-6 weeks.

      In consultation with the Office of Research, we are adopting a short-term triage policy.  Our top priority will be the following:

      • New applications and modifications required in order to receive new federal funding
      • H1N1 flu-related studies (such as vaccine trials)
      • Status reports (the annual renewal of existing IRB approvals)
      • Truly urgent applications from student researchers

      Action on all other applications and modifications is likely to be postponed for up to a month.  This will ensure that UW researchers will be able to receive their federal funding awards. 

      In addition, we have asked all HSD staff (including management) whose work does not directly involve IRB reviews to set aside everything that is not truly urgent in order to assist the IRBs and IRB support staff.

      We appreciate your understanding and patience during this very unusual set of circumstances.  Please feel free to contact me (kemoe@u.washington.edu ) if you have any questions or concerns.

      Thank you,
      Karen Moe
      Director, Human Subjects Division
      Assistant Vice Provost of Research
      kemoe@u.washington.edu

    • New Performance Metrics Report

      Sep 18, 2009 at 10:48am

      The third Report of Key Performance Metrics for the Human Subjects Division (HSD) and the UW Institutional Review Board (IRB) has now been posted.  You can read it by clicking on the permanent “Metrics” graphic in the upper left corner of HSD’s homepage or, more directly, by clicking on this link:

      http://www.washington.edu/research/hsd/topics/HSD+metrics

      Please notice the Survey link at the bottom of the webpage that lists the reports.  We welcome your comments about this report and your suggestions for future quarterly reports!

    • Procedure Update: Materials Stamped with IRB Approval - (#P-339)

      Aug 28, 2009 at 3:39pm

      A revision has been posted for the document describing which materials must receive an IRB approval stamp and which of the stamped materials a researcher must use.

       

      The previously-posted document was written in early 2008 when HSD's policy about stamping changed. It contained implementation directions to researchers about what to do, depending upon the date when their application had been approved. These instructions have been removed, because these instruction dates have passed.

       

      Finally, this document clarifies that the HIPAA Authorization Form should NOT be stamped.  This is a change from previous documents, and represents the advice of the UW Attorney General. 

       

      Procedure: Materials Stamped with IRB Approval

    • Now Quicker & Easier: Training Verification & Report

      Aug 19, 2009 at 1:58pm
      Verifying completion of training in the protection of human research subjects is now quicker and easier, as is generation of a report for printing or direct submission to the Office of Sponsored Programs (OSP). A new, web-based tool is available on the HSD web site for training verification and reporting. Those who need training verification can view a single individual's completion record or generate a list of participants who have completed training, for example from a single study. The online form makes it possible to print a report.  Researchers and research staff may also enter a study's eGC1 number and submit a report directly to OSP, which will be provided to the sponsor / funding agency. Reminder: Training completions are posted to the HSD web site each Monday from the preceding week (Monday - Sunday).

    • Document Updates: Status Report and Closure Date Policy

      Aug 5, 2009 at 3:14pm

      The Status Report Form (#J-342)  B. Subject Numbers has been modified to include this instruction for the table:

      "Do NOT cut and paste from last year's Status Report"

       

      The Closure Date of IRB Application Policy (#J-868) has been implemented and posted to the HSD website:

      http://www.washington.edu/research/hsd/docs/868

      Please contact Sherry Edwards (sherrye@u.washington.edu) if you have any questions or comments.

       

    • POLICY CHANGE: Subject payment and Social Security Numbers

      Jul 8, 2009 at 1:28pm

      Researchers and the UW IRB have expressed concerns about the requirement to ask research subjects for their Social Security number in order to pay subjects for participating in research.  In response to these concerns, HSD and UW Financial Management have been working with University officials about the possibility of changing this policy.  We are pleased to announce that the policy has been revised, effective immediately, as follows:

      New Policy:
      When a onetime payment of $50 or less is being made to a research subject, the requirement to obtain a Social Security number is waived.  However, the University of Washington strongly encourages researchers to request Social Security numbers for all research subject payments.

      For research subjects who are known to be foreign nationals:  Tax identification numbers should always be obtained for foreign nationals regardless of the dollar amount.

    • 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.

    • Update: Research Involving the VA

      Jul 8, 2009 at 1:24pm
      The IRB arrangement between the UW and the local VA ended as of July 1, 2009.  The VA Puget Sound Health Care System now has its own independent IRB. We are very grateful to researchers and study coordinators for their prompt responsiveness to the several requests we made during the past few months.  Your help made the transition go more smoothly than expected.  Thank you! All researchers whose studies now are under dual IRB oversight ("dual review"; i.e., oversight by the UW IRB and by the VA IRB) have received an email memo from the UW IRB indicating:
      • The UW IRB committee to which each study has been assigned
      • The name and contact information for the HSD administrator that leads the staff support team for the IRB committee
      Additional information about UW involvement in VA research has been posted on HSD's website, to assist researchers in navigating the IRB review process when both institutions are involved in a research study.  This webpage describes the procedures to follow:  http://www.washington.edu/research/hsd/va/   On the right side of this webpage, there is a link to a document entitled "UW Engagement in VA Research".  This document guides researchers in determining whether a specific study requires dual review and oversight.

    • Effective July 1: Industry-sponsored clinical trials and significant changes concerning Western IRB

      Jun 17, 2009 at 12:48pm

      WIRB (Western IRB)
      Significant Changes to Submission Process

      Effective:  July 1, 2009

      Relevance:       This applies only to industry-initiated-and-sponsored clinical trials, which are generally reviewed by Western IRB (WIRB) for the UW IRB.

      Purpose of the changes:  

      • 1. Reduce HSD screening time, by:
      • Allowing the use of email to send documents to HSD, and to return documents from HSD to the researcher
      • Reducing the "back and forth" between WIRB, HSD, researchers, and sponsors about certain sections of consent documents
      • 2. Enhance compliance oversight

      Description of the changes.  The Human Subjects Division (HSD) has always provided an authorization for WIRB's review, by requiring researchers to fill out and submit a UW / WIRB Cover Sheet.  HSD reviews the Cover Sheet, signs it, and returns it to the researcher.  The researcher includes the Cover Sheet with the application packet that he/she sends to WIRB.  The changes in this process are:

      • Electronic transmission. All documents for this process (except Confidentiality Agreements) may now be sent to and from HSD electronically (by email).
      • The UW / WIRB Cover Sheet has been revised to include some additional questions.
      • New required attachments to the Cover Sheet. All of these attachments are parts of the application packet required by WIRB. Researchers will simply be providing a copy to HSD; there are no new forms to complete.
      • The Compensation for Injury section of the consent form template has been revised, to ensure compliance with UW policies and to provide researchers & sponsors with suggested language.
      • Screening of consent forms and HIPAA Authorization forms. HSD will screen and evaluated the consent form(s) and HIPAA Authorization form. After screening is completed, HSD will stamp the consent forms and UW HIPAA Authorization form, to signify to WIRB that the Injury Compensation for Injury language in the consent form and the HIPAA language are acceptable and follows UW policies. The stamped versions must be submitted to WIRB together with other WIRB-required documents.

      UW / WIRB Cover Sheets submitted to HSD using old versions of forms and procedures will not be accepted after July 1, 2009.

    • A new IRB Committee is forming.

      Apr 28, 2009 at 10:47am

      A new UW IRB Committee is being created.  This is because we are losing two IRB Committees (Committees V and V2) when the IRB relationship between the UW and the VA dissolves on July 1.  Also, we expect a significantly increased workload because of federal stimulus funding for research.

      Committee K will be a hybrid IRB that will generally focus on studies combining biomedical and behavioral components.  We expect that the committee members will find this an engaging and informative portfolio of studies.

      It will meet every other week, like the other IRB committees.  The meeting day and time have not yet been established, but the possibilities include Tuesday morning or afternoon, Wednesday morning or afternoon, and Thursday afternoon.  We hope the new IRB will be ready to start meeting in late June or early July.

      We are actively recruiting faculty and professional staff members for IRB Committee K.  We are especially interested in anyone who has previous experience as an IRB member, but newcomers are welcome, too.  If you are interested, please contact Shannon Sewards for more information:

      Shannon Sewards, Assistant Director of Operations
      ssewards@u.washington.edu   206-543-2254

    • Are you planning any human subjects research related to the current swine flu outbreak?

      Apr 28, 2009 at 10:44am

      UW researchers may be planning to study this emerging and rapidly evolving situation - perhaps looking at biomedical issues, or at social/behavioral issues such as the impact of social networking sites on individuals' behaviors and thoughts.

      If you think you may do human subjects research of any type that is related to the current swine flu outbreak, please contact one of the following individuals at the UW Human Subjects Division (HSD) as soon as possible - ideally, before you finish devising your research design, procedures, and documents such as questionnaires.  We will work with you or your staff to very rapidly facilitate your IRB application, review, and approval so you can start your research as soon as possible.

      Shannon Sewards    ssewards@u.washington.edu   206-543-2254
      Karen Moe    kemoe@u.washington.edu  206-543-7246
      Sharon Elsayed    selsayed@u.washington.edu  206-685-9110
      Wendy Brown   wbrown3@u.washington.edu  206-543-5602
      At the VA:   Amy Marsh   amymarsh@u.washington.edu  206-764-2670

    • July 1 Separation of the UW IRB and the VA

      Apr 28, 2009 at 8:12am

      As of July 1, the UW IRB will no longer provide IRB review and oversight for research at the VA Puget Sound Health Care System (VAPSHCS) or the Boise VA Medical Center.  VAPSHCS is forming its own independent IRB, which will begin operations on July 1, 2009 and which will provide IRB oversight of all research at VAPSHCS and Boise VA.

      1.  What is the reason for the separation?

      This action is required by the VA Office of Research Oversight in response to its audit last fall.

      2.  What does this mean for research that involves both institutions (UW and VA)?

      As of July 1, all research in which the UW and the VA are both engaged (as defined by federal regulations; http://www.hhs.gov/ohrp/policy/engage08.html  ) must be reviewed by both the UW and the VA IRBs.   This is called dual review.

       3.  Why is dual IRB review necessary?

      The VA central research office will not allow its IRBs to rely on the IRBs of other institutions, nor will it allow other IRBs to rely on the reviews of VA IRBs.

       4.  What  does this mean for my research study that is reviewed by UW IRB Committee V, V2, EV, or EV2?

      If you are a VA researcher and your research does not involve the UW:  As of July 1, you should use the forms and procedures that will be provided on the VAPSHCS website.  

      If you are a VA researcher and your research involves the UW (for example, the research funding is administered through the UW Office of Sponsored Programs, or you or the research staff are UW employees), OR if you are a UW researcher and your research involves the VA (for example, you are recruiting from a VA patient population or a VA colleague is doing assays for you):  your research will be reviewed by the new VA IRB andyour research will be reviewed by UW IRB Committee A, B, C, D, G, J or a Minimal Risk team.  You will need to submit all future paperwork to both IRBs, using each IRB's specific form (modifications, annual Status Reports, adverse event reports, etc.)

       5.  What does this mean when I want to start a new study that involves both the UW and VAPSHCS?

      You will need to submit an application to both the UW IRB and the VA IRB.  Our two institutions are currently designing procedures to minimize the extra paperwork and effort required.  These procedures will be widely publicized, and will be prominently posted on the UW and VA websites.

       6.  How can I find out more?

      There will be a Research Town Hall meeting to discuss the transition from the University of Washington IRB to a newly constituted VA IRB.

      Date:    Thursday, May 14, 2009

      Time:    1:30-3:00 PM

      Presenters/moderators
      Dr. Steven Kahn, ACOS for Research & Development, VAPSHCS
      Dr. Karen Moe, Director, UW Human Subjects Division

      VA location
      Seattle Division, Building 100, Room BB108

      Other VA locations
      VTEL videoconferencing will be set up at American Lake, Met Park, and the Boise VAMC

      UW location
      A live video broadcast of the meeting will be provided in Health Sciences T239.  Representatives of the UW Human Subjects Division will be present.

    • Instruction changes to the Status Report Form

      Apr 24, 2009 at 1:04pm

       

      1. A change in the definition of a Serious Adverse Event has been made to the Status Report Form (doc. # J-324).  The definition has been expanded to provide accurate information about current reporting requirements, and to be consistent with the current reporting instructions on the Adverse Event Report Form (doc. # U-755).

       

      Please see the new, and the old definitions below, as excerpted from the Status Report Form:

       

      NEW DEFINITION:

      A serious adverse event (SAE) is when the subject outcome is death, hospitalization, life-threatening, disability and/or incapacity, congenital anomaly, pregnancy involving significant risk to the fetus, or the event requires intervention to prevent the outcomes listed above. The SAE should be reported immediately IF there is a reasonable possibility* the event is attributable to the study. 

      ·          *The UW defines ‘reasonable possibility’ as “more likely than not,” that is, there is a >50% likelihood of the event having been caused by or partially caused by the research or arising from the circumstances of the research.  Problems are considered unrelated to research participation if they are caused solely by:  A subject’s underlying disease, disorder or condition or other circumstances unrelated to the research activities.

       

      OLD DEFINITION:

      A serious adverse event (SAE) is when the subject outcome is death, hospitalization, life-threatening, disability and/or incapacity, congenital anomaly, pregnancy involving significant risk to the fetus, or the event requires intervention to prevent the outcomes listed above. The SAE should be reported immediately.

       

      2. An instuction was added to the Consent Materials section of the Status Report Form (doc. # J-324) instructions.  The new instructions were added to aid in clarification of what consent materials need to be sent in with the Status Report Form.  Please see the new instruction below:

       

      –   Do not submit copies of consent forms signed by individual subjects but rather a copy of the consent form(s)/materials you use to consent prospective subjects.

    • American Recovery and Reinvestment Act (ARRA)—also known as the Stimulus Package or Recovery Act

      Mar 23, 2009 at 4:25pm
      UW researchers are already starting to hear from federal funding agencies that they will be receiving ARRA funding.  Because of the very tight time requirements associated with this funding, researchers should contact the Human Subjects Division (HSD) as soon as possible after being notified of the possibility of funding, so that the IRB review process can be responsive to the time requirements.  Do not wait until your IRB application is ready to send to HSD.  Here are the Instructions ARRA Stimulus-Recovery Funding to follow ASAP, to get you started. Contact Shannon Sewards by email at ssewards@u.washington.edu or by phone at 206-543-2254. A checkbox for ARRA funding has been added to each of the documents listed below on March 22, 2009 *: • Biological Specimens Review Determination Form (Page 5) • Center Program Training Grant Application (Page 3) • Human Subjects Review Application: UW 13-11 (Page 3) • Medical Records Review Form (Page 3) • Modification Form (Page 16) • Repository Application (Page 3 & 4) • Status Report - Renewal or Closeout Form (Page 4) *  The ARRA checkbox was the only change made to these documents on 3/22/09. The ARRA Cover Sheet is to be used with all IRB submissions for research funded by the ARRA. More information about the ARRA, including information about how to apply for the funding and how to administer these grants at the UW is available.

    • Paying Research Subjects – Check Request Policy

      Mar 23, 2009 at 4:21pm
      Effective May 1, 2009, the Check Request method can no longer be used for making payments to UW research subjects unless the subjects are foreign nationals.  Instead, subjects must be paid using a department revolving fund, a field advance, or a gift card. This change is required because the Check Request method is the only payment method that results in the inclusion of identifiable subject information in the UW’s Financial Accounting System (FAS).  On May 1st, a new Open Access policy for FAS will significantly increase the number of people with access to UW budget information.  To best protect the confidentiality of subjects, alternative payment methods must be used. To open a department revolving fund, follow the simple procedures described at: http://www.washington.edu/admin/finserv/bankops/pcobtain.html Contact Karen Long (kong@u.washington.edu; Financial Management) or Karen Moe (kemoe@u.washington.edu; Human Subjects Division) if you have any questions. Two HSD documents have been revised in response to this policy change: T-272:  Subject Payment Procedure T-278:  Subject Payment, Confidentiality, and Income Tax NOTE: This policy and accompanying changes do not apply to payments provided through the VA system.

    • Update: Restrictions related to the November 2008 audit of the VA’s Human Research Protection Program

      Feb 10, 2009 at 7:57am
      One outcome of the VA audit is that all research already reviewed and approved by UW IRB Committee V or V2 must be re-reviewed by the IRB.
      1. The VA Central Office has informed the Puget Sound VA and the UW IRB that we need to complete ALL of these re-reviews by April 1, 2009.
      2. In order to accomplish this, all required forms and paperwork required for the re-review must be submitted to the VA IRB office by close of business on Friday, February 27, 2009.  The forms and instructions are located on the UW HSD webpage at:http://www.washington.edu/research/hsd/va/ The instruction document is titled, “VA PI Re-review Instructions”.
      3. If the research is being conducted at the VA (VAPSHCS), failure to submit this documentation by 5:00 PM, February 27, 2009 will result in automatic closure of the protocol, by order of the Director of VAPSHCS.  A new, full, application to the IRB will then be required to re-open the research.
      4. If you are acting as the responsible VA investigator for a principal investigator not based at VAPSHCS and research is no longer being conducted at VAPSHCS, you may request that the study be re-assigned to one of the other UW IRBs.  You will need to review the document “Requesting IRB Re-assignment Procedure” (at the above website) to determine whether your study qualifies for re-assignment.
      Please contact Amy Marsh at amy.marsh@va.gov or 206-764-2670 if you have any questions about this process.

    • The Office of Sponsored Programs has released an important Reminder & Update about Industry-Sponsored Clinical Trials.

      Dec 8, 2008 at 1:54pm

      The Office of Sponsored Programs (OSP) is responsible for negotiating and finalizing all UW research agreements, including those relating to clinical trials and similar clinical research studies.  Because this is a subject that has received a fair amount of recent attention, we thought it would be useful to update you on a number of matters:

       

      1.      The UW's Human Subjects Division has recently clarified that the UW's own program for providing compensation for subjects experiencing injuries as a result of participating in clinical research does not apply to industry-sponsored clinical trials.

       

      2.      It should be noted that the foregoing clarification of the UW's subject injury program has no effect on our long-standing indemnification requirement for sponsor-initiated clinical trials.  For contracts covering these trials, the UW will continue to require that a financially responsible party (other than the federal government) agree to indemnify the UW for all claims by subjects who allege they have been injured as a result of participation in the trial.  However the UW will not require indemnification to the extent the claimed injuries are the result of the UW's failure to perform its responsibilities under the contract and protocol.

       

      3.      Because the UW has clarified that its subject injury compensation program is not available for subjects injured in industry-sponsored clinical trials (see #1 above), the UW will generally require that the industry sponsor make appropriate arrangements for such a program.  The UW will waive this requirement only under limited, special circumstances and for good cause.

       

      4.                  All provisions in the UW's clinical trial agreements (and any other arrangements with sponsors of clinical trials) pertaining to either reimbursement or submission of insurance claims for injuries by subjects participating in clinical trials will be consistent with all applicable laws, rules and regulations.

      If anyone has any questions about this, please feel free to contact OSP directly - (206) 543-4043.

    • All research involving the VA must be re-reviewed.

      Dec 8, 2008 at 1:33pm

      Certain restrictions and conditions have been imposed upon human subjects research at the VA Puget Sound Health Care System (VAPSHCS) and the Boise VA Medical Center (VAMC) as the result of a recent audit by the VA’s Office of Research Oversight.

       

      One of those conditions is that all research already reviewed and approved by UW IRB Committee V or V2 must halt enrollment of new subjects at the VA, further acquisition of data and tissue at the VA, and analysis or publication of data housed at the VA until the research has been re-reviewed by the IRB.

       

      The principal investigators (PIs) of these studies must provide the IRB with some specific materials required for the re-review.  These materials, and instructions on how to complete them, are provided on the HSD web site at:  

       

      http://www.washington.edu/research/hsd/va

       

      One required item is an Addendum to consent forms.  When an Addendum has been approved by the IRB, the PI will be required to provide the Addendum to all current subjects, and to obtain each subject’s signature and a witness signature on the Addendum.  This can be done the next time each subject comes for a clinic or research visit.

      Please contact Amy Marsh at amy.marsh@va.gov or 206-764-2670 if you have any questions.

    • HSD Has Moved to the UW Tower - Effective June 16, 2008

      Jun 17, 2008 at 7:53am
      WHEN Effective June 16th, 2008, the Human Subjects Division has moved to the UW Tower, located at the corner of NE 45th Street and Brooklyn Avenue NE. EXPECTED DELAYS Due to our move, packing, and unpacking of HSD files – please expect some delay in processing and/or review from Wednesday, June 11 through Wednesday, June 18. BUILDING ENTRANCES
      • Main entrance at the corner of Brooklyn Ave NE and NE 45th Street
      • Second entrance from parking garage via skybridge over 12th Ave NE
      BUSINESS HOURS While HSD business hours are 8:00 am to 5:00 pm, the UW Tower is open from 6:00 am to 6:00 pm, Monday through Friday. VISITOR ACCESS University affiliated visitors with a Husky Card will have access to the UW Tower during business hours and will need to swipe their card through the turnstile magnetic card readers upon entry. Non-University affiliated visitors will be required to check-in with a photo ID at one of the two staffed visitor desks.  One is located in the main lobby in the Tower atrium; the other is located inside the building just across the sky bridge from the parking garage. MAIL/DELIVERY OPTIONS PARKING & TRANSPORTATION

    • New UW Medicine Policy Requiring Research Information in Subjects' Medical Records

      May 7, 2008 at 1:15pm
      Studies that use UW Medicine clinical facilities (including Harborview & SCCA) will soon be required to add a Research Care Plan to subjects' medical records, using a predefined template. The purpose is to improve patient safety and to help researchers fulfill Medicare requirements for documenting and billing for services related to research. The Research Care Plan lists appropriate contact information for the study. In addition, it will include the study name (in an abbreviated manner), the sponsor name, and the protocol number - as this is information required by Medicare. Most ongoing studies covered by this policy will need to revise their consent forms, and some may also need to re-consent subjects. A special page has been established with more details, forms, and instructions.

    • IRB Application Number Change - List of Old & New Numbers Posted - Effective February 4, 2008

      Feb 6, 2008 at 9:22am
      On February 4, 2008, the Human Subjects Division deployed a new internal database. The number assigned to your IRB application (e.g., 07-1234-A 01) has changed to a new, 5-digit number. Both the old and the new numbers are available to you in the document New DORA Study Numbers and Old HSD Application Numbers, which also includes the name of the PI and the IRB Committee. Please use your new application number on all correspondence and submissions to HSD after 2/4/2008. However, be assured that the new number will be linked to the old number in our new database, and HSD staff will have the capability to look up/reference the previous number.

    • Revised Confidentiality Agreement Form and Guidance - Effective February 4, 2008

      Feb 4, 2008 at 9:24am
      The Confidentiality Agreement form has been revised, following consultation with the UW Attorney General's division. The Agreement is now required for access to only UW records. This includes SCCA records, but does not include records from the VA, school district records, Puget Sound Blood Center, etc. The revised policy is incorporated into the form instructions. Please review both new documents, the Confidentiality Agreement and the Confidentiality Agreement Guidance, carefully for significant changes to this process. In recognition of the time it can take to obtain all required signatures on the form, old versions of the Confidentiality Agreement form will accepted until March 1st. Existing Confidentiality Agreements do not need to be replaced.

    • New Procedure & Guidance for Subject Payment

      Jan 29, 2008 at 9:25am
      The following documents have been posted to the Policy & Procedures page , making them available to HSD staff, IRB members, researchers, and participants in research:

    • New Policy & Procedure on Public Data Sets

      Jan 28, 2008 at 9:26am
      In response to requests from several UW research groups, the Human Subjects Division has examined the regulations and regulatory guidance about the research use of public data sets. A new Public Data Sets Policy describes the results of the analysis. It confirms that there are specific public data sets whose research use does not require review and approval by the UW Institutional Review Board (IRB), because the data sets do not involve 'human subjects' as defined by federal regulations. The associated Public Data Sets Procedure describes the procedure for nominating public data sets for addition to the list. It also describes the procedures for researchers to follow if they require documentation (for example, for funding agencies) that proposed public data set research activities do not require IRB approval or certification from exemption.