VA Central IRB

1. VA Central IRB K. Lynn Cates, MD Assistant Chief Research & Development Officer Annette R. Anderson, MS, RHIA, CIP VA Central IRB Administrator PRIM&R November 15, 2009

2. Human Research Has Changed New opportunities Electronic age Larger, more complex studies Faster translation to clinical care New risks Database Research (e.g., Medicare) Genomics Research 2

3. 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 of IRB reviews 3

4. Projects Reviewed by VA Central IRB VA-funded studies only VA facilities that do not use the VA Central IRB will not be able to participate in projects reviewed by the VA Central IRB 4

5. Local VA Facility Requirements Local VA facilities that plan to use the VA Central IRB must: Amend their FWAs 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 5

6. Local Accountability Concept of Human Research Protection Program (HRPP) vs. IRB 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) 6

7. 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 IO to appoint the local site representatives to do the following: • 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

8. VA Central IRB Operations No charge to the field for using the VA Central IRB Staffed by PRIDE Monthly meetings Ad hoc expert advisors VA Central IRB website 8

9. VA Central IRB Reviews Convened Board Expedited Exempt Continuing Waiver of HIPAA-compliant authorization 9

10. VA Central IRB Composition 20 voting members 5 nonvoting members Ethics Legal Affairs Regulatory Affairs Privacy & HIPAA Information Security Officer 10

11. Progress to Date 73 VA facilities have signed up 22 studies reviewed involving 150 sites 4 continuing reviews performed Implementation of new model – more efficient 11

12. Future Plans • Implement wide use of SharePoint for document sharing • Develop electronic system for submissions and document management • Submit AAHRP application in March 2010 • Ongoing formal peer-reviewed evaluation • Create a second VA Central IRB as workload increases

13. Application Process 2 kinds of applications Principal Investigator (PI) or Study Chair (SC) Application Co-PI Supplement Coordinating Center Supplement Local Site Investigator (LSI) Application 13

14. PI/SC Application Process PI or SC enlists local VA facilities Check VA Central IRB web site 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 Federalwide Assurance (FWA)) Notify VA Central IRB staff of all potential participating VA facilities that are not listed ASAP 14

15. Key Elements of the PI/SC Application Protocol must clearly differentiate clinical from research activities Protocol must be consistent with The PI/SC Application Informed consent form HIPAA authorization 15

16. Key Elements of the PI/SC Application Protocol must contain sufficient information for the IRB to evaluate all regulatory criteria for approval of research Model informed consent documents and recruitment materials Waiver requests Signed by PI/SC, PI/SC’s supervisor, and ACOS/R&D of PI/SC local site 16

17. Administrative Pre-Review • Not required but highly recommended, especially for studies requiring review by the convened IRB • Can identify problems with informed consent forms, recruitment materials, waiver requests or lack thereof; and missing or incorrectly completed documents; selection of sites; and other issues

18. Administrative Review • Administrative Review by assigned VA Central IRB Coordinator • Primary Reviewer System with extensive use of reviewer checklists • Any reviewer can contact investigator for response to questions or they can go through VA Central IRB staff • Ad hoc reviewers as needed

19. Potential VA Central IRB Actions Approve the study Approve the study contingent upon minor modifications (Convened Board) Require Modifications (Expedited Review) Defer the study pending major modifications Disapprove 19

20. Local Site Initial Review After the PI/SC application is approved by the VA Central IRB, or approved contingent upon minor modifications A copy of the approved PI/SC Application packet is sent to each local site for review while Local Site Investigators (LSIs) prepare LSI applications 20

21. Local Site Initial Review After the PI/SC application is approved by the VA Central IRB, or approved contingent upon minor modifications Each local site has 30 days to provide comments to the VA Central IRB Comments are provided to the VA Central IRB by the liaison designated by the medical center director (NOTE: the local IRB of record does not have perform a review or provide the comments unless designated by the medical center director) 21

22. LSI Application Process Each Local Site Investigator (LSI) prepares a Local Site Application based on 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 22

23. Review of Local Site Comments VA Central IRB reviews all local site comments & is final arbiter of: Changes to the PI/SC Application Global changes in protocol (affect all sites) Local changes in protocol (affect local site) 23

24. Review of Local Site Investigator Applications • Usually reviewed in conjunction with local site comments but can be reviewed after depending upon timing of receipt • Review by convened IRB or by expedited review procedures with review outcomes: • Approved Contingent on minor modifications • Deferred for Major Modifications • Disapproved

25. Local Facility Participation Decision 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 sent to the site 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 25

26. Continuing Review • VA Central IRB staff notifies PI and LSIs of continuing review deadlines • Each 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 study, not for each specific site so that all sites for a given study get on the same review cycle

27. Adverse Events, Unanticipated Problems, and Protocol Deviations • Table of Reporting Requirements is on the VA Central IRB website and is forwarded with each final approval letter • Specific Reporting forms for Adverse Events/Unanticipated Problems and for Protocol Deviations on website

28. Contact Information Lynn Cates, MD Assistant Chief Research & Development Officer Director, PRIDE 202-461-1811; lynn.cates@va.gov 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 28