VA Central IRB

1. VA Central IRB Annette R. Anderson, MS, RHIA, CIP VA Central IRB Administrator Local Accountability Meeting June 2011

2. VA Central IRB Purpose Improve human research protection in VA multi-site studies by ensuring Consistent expert ethical & scientific review Local issues are addressed Enhance efficiency and consistency of multi-site IRB reviews 2

3. Projects Reviewed by VA Central IRB VA Office of Research and Development (ORD) funded studies only with some exceptions (SPRINT NHLBI-funded study) VA facilities that do not use the VA Central IRB will not be able to participate in projects reviewed by the VA Central IRB - there can be no IRB shopping 3

4. Local VA Facility Requirements Local VA facilities that plan to use the VA Central IRB must: Amend their Federalwide Assurance (FWA) to include the VA Central IRB as one of their IRBs of record Enter into a Memorandum of Understanding (MOU) with VHA Central Office Develop standard operating procedures (SOPs) for using the VA Central IRB as an IRB of record Modify affiliate MOU if appropriate 4

5. Memorandum of Understanding • Spells out the respective authorities, roles and responsibilities of the VHA Central Office Human Research Protection Program (HRPP), the VA Central IRB, and the local VA facility • Requires the Medical Center Director (IO) to appoint the local site representatives to: • Provide comments to VA Central IRB on initial project review determinations • Provide final local site participation decision • Serve as local site liaison with VA Central IRB

6. Local Accountability Every VA facility that performs human research has ultimate responsibility for its HRPP, even if it uses an external IRB (e.g., affiliate’s, another VA’s or the VA Central IRB) Include the VA Central IRB as part of local VA facility annual review of its HRPP 6

7. VA Central IRB Operations IO is Principal Deputy Under Secretary for Health Staffed by Program for Research Integrity Development and Education (PRIDE) No charge to the field for using the VA Central IRB Monthly meetings or more frequently as needed Ad hoc expert advisors VA Central IRB website 7

8. VA Central IRB is a Full Service IRB Convened Board and Expedited Continuing Reviews and Amendments Exempt Reviews Waivers of HIPAA-compliant authorization and Informed Consent SAE/UAP; Protocol Deviations; and Reports of Noncompliance The VA Central IRB does not review the emergency use of test articles 8

9. VA Central IRB Composition 17 voting members from across the country, including two Co-Chairs 5 nonvoting members Ethics Legal Affairs Regulatory Affairs Privacy & HIPAA Information Security Officer 9

10. Progress to Date 94 VA facilities have amended their FWA listing the VA Central IRB as an IRB of Record 46 studies reviewed involving over 400 sites since inception in August 2008 AARHPP site visit took place in February 2011 and results will be reviewed at June AAHRPP Council First routine ORO site visit scheduled for end of August 2011 10

11. Application Process -2 Processes Principal Investigator (PI) or Study Chair (SC) New Project Application Co-PI and Coordinating Center Supplements Protocol and other documentation (i.e., investigator drug brochure, surveys, scripts, case report forms) Waiver requests and Vulnerable Population Supplements Model Documents (i.e., recruitment materials, informed consent forms Local Site Investigator (LSI) Application 11

12. Key Elements of the PI/SC Application Protocol must clearly differentiate clinical care from research activities Protocol must be consistent with The PI/SC Application Informed consent form HIPAA authorization form Protocol must contain sufficient information for the IRB to evaluate all regulatory criteria for approval of research 12

13. Key Elements of the PI/SC Application List of potential participating facilities PI or SC enlists local VA facilities Check VA Central IRB website to see if all potential participating sites have listed the VA Central IRB as an IRB of record If not listed, verify with the VA facility that it can perform human research (i.e., that it has a FWA) Notify VA Central IRB staff of all potential participating VA facilities that are not listed ASAP Signed by PI/SC, PI/SC’s supervisor, and ACOS/R&D at the PI/SC’s VA facility 13

14. Administrative and Designated Reviews • Administrative Review by assigned VA Central IRB Coordinator and Regulatory Advisor • Primary Reviewer System with extensive use of reviewer checklists • Privacy Officer and Information Security Officer Reviews • Any reviewer can contact investigators for response to questions or they can go through VA Central IRB staff • Ad hoc reviewers as needed

15. Potential VA Central IRB Actions Approve the study Approve the study contingent upon required minor modifications (Convened Board) Approve contingent upon local site comment Require modifications (Expedited Review) Defer the study pending major modifications (Convened Board) Disapprove 15

16. Local Site Initial Review After the PI/SC application is approvedcontingent upon local site comment, or approved contingent upon required minor modifications A copy of the approved PI/SC Application packet is sent to each local site for review, along with a copy of the VA Central IRB approval letter Local Site Investigators (LSIs) can begin preparing LSI applications 16

17. Local Site Initial Review Each local site has 30 days to provide comments to the VA Central IRB A form has been developed for this purpose Comments must be provided to the VA Central IRB by the individual designated by the Medical Center Director; usually one of the following: R&D Chair Local IRB Chair ACOS or AO for R&D 17

18. LSI Application Process Each LSI prepares a LSI Application based on the approved PI/SC Application The PI/SC reviews all LSI Applications for consistency The VA Central IRB will require a justification for any differences among the LSI Applications including the informed consent forms 18

19. Review of Local Site Comments VA Central IRB reviews all local site comments and decides if changes are needed as follows: No changes needed; comments or questions of an administration nature only were received, or a no further comments response provided Changes required in PI/SC Application (may or may not affect LSI Applications;) Changes required in specific LSI Application only (affects only local site making comment) 19

20. Review of Local Site Investigator Applications • Usually reviewed in conjunction with local site comments but can be reviewed after depending upon timing of receipt • Reviewed by convened IRB or expedited review procedures and: • Approved • Approved contingent on required minor modifications • Deferred for major modifications • Disapproved

21. Local Facility Participation Decision Once a LSI Application is approved, local VA facilities have 10 work days to decide whether or not to participate If a facility decides to participate, a copy of the applicable VA Central IRB minutes is posted to its SharePoint site A facility can still suggest changes but if the VA Central IRB, PI, or LSI do not accept the changes, the facility can decide not to participate in the study 21

22. Local Facility Approval Local VA facility must approve the research in accordance with VHA Handbook 1200.01 (R&D Committee) and local procedures before research can be initiated at that facility Copy of Local VA facility approval must be forwarded to VA Central IRB and to LSI Sites added after a study is approved are not given 30-day comment period; however, a site can always provide comments 22

23. Continuing Review • VA Central IRB staff notifies PI and LSIs of continuing review deadlines • Each local participating site submits a continuing review report to PI/SC • PI/SC prepares summary report and submits to VA Central IRB, along with copies of LSI reports • Continuing review date is set for the overall study, not for each site; all sites for a given study are on the same IRB review cycle

24. Adverse Events, Unanticipated Problems, Protocol Deviations, and Complaints • Reported to VA Central IRB, not the local IRB • Table of Reporting Requirements is posted on the VA Central IRB website and is referenced in each final approval letter • Specific Reporting forms for Adverse Events, Unanticipated Problems, and Protocol Deviations are posted on VA Central IRB website • Other reports of noncompliance or complaints must be reported as they occur

25. Future Plans • Improve communications with sites by improving website content • Instituting periodic webinars for new site liaisons and for when changes occur • New Handout for Liaisons • Revise Memorandum of Understanding to incorporate changes and improve communications • Transition to a fully electronic system

26. Contact Information Annette Anderson, MS, RHIA, CIP VA Central IRB Administrator 202-461-1813; annette.anderson3@va.gov Websitehttp://www.research.va.gov/programs/pride/cirb/default.cfm Toll free number 1-877-254-3130 Email va.central.irb@va.gov 26