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

 

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.

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.

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.

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.

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 and Adverse Events 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.]

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

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/metrics.php

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!

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

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).

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/formRetrieve.php?ver=accreditation&id=586

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

 

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.

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.

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.

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.

If the current IRB PI does not have a VA appointment, s/he must identify a VA PI, effective July 1

• A Special VA PI Modification Form must be submitted and approved by Committee V, V2, EV or EV2 before July 1 otherwise work at the VA will be halted
• The Special VA PI Modification Form can be found on the VA HSD webpage
• The IRB review of this modification qualifies for review via an expedited process

If the current IRB PI does have a VA appointment, no further action is required.

Additional information is available on the HSD web site, VA Forms & Information Page. A copy of the PowerPoint presentation from the Town Hall Meeting held on Thursday, May 14th is also available: Transition from the UW IRB to an Independent VAPSHCS IRB.

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

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

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/humansubjects/guidance/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.

 

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.

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.

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.

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 (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.

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.

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

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.

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.

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.

The following documents have been posted to the Policy & Procedures page , making them available to HSD staff, IRB members, researchers, and participants in research:

• Subject Payment Procedure
• Subject Payment Guidance
• Subject Payment, Confidentiality, and Income Tax

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.