1. VA Central IRB K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs September 6, 2006

2. 2 VA Central IRB Purpose Review VA-funded multi-site studies Continue to promote highest quality human subject protection by ensuring Appropriate ethical & scientific review Sensitivity to community attitudes Enhance efficiency of reviews

3. 3 VA Central IRB Examples of Research Projects Quality Improvement & Organizational Research Database Research Nursing Research Cooperative Studies Genomics Research

4. 4 VA Central IRB Logistics No charge to the field for using the VA Central IRB Staffed by PRIDE in ORD IRB members from all over the country One IRB with “panels” Monthly meetings (at minimum) Electronic submission Evaluation tool MOU with local facilities

5. 5 MOU Between Local Facility & VA Central IRB “Crisp” agreements with clear delineation of respective Roles Responsibilities Authorities

6. 6 VA Central IRB Process Investigator submits protocol to VA Central IRB including list of participating VA facilities VA Central IRB performs review Local VA facilities provide comments (e.g., local issues & state & local language) VA Central IRB is final arbiter Local VA facilities decide whether to opt in Investigator may independently pursue approval from sites that did not opt in after final VA Central IRB approval

7. 7 VA Central IRB Roll-out VA-funded research only First - Multi-site VA Health Services Research & Cooperative Studies Then - Will consider the possibility of serving as IRB of record for small research programs More panels

8. 8 VA Central IRB Advantages More consistent expert ethical & scientific review More training & experience for IRB Centralized investigator accountability Earlier identification of trends in adverse events Elimination of local institutional conflict of interest Improved veterans’ access to multi-center trials Improved efficiency More consistent process with templates for submissions & informed consent forms Transparent process/model for local IRBs

9. 9 VA Central IRB Challenges Assurance of review quality Local accountability Ownership by local IRBs Expectations that it will solve everyone’s problems Local IRBs at a few small research programs may go out of business Affiliate relationships Conflict of interest Communication

10. 10 Local Accountability Concept of Human Research Protection Program (HRPP) vs. IRB Every facility that performs human research has ultimate responsibility for its HRPP, even if it uses another facility’s IRB Institutional Official must designate an entity (e.g., IRB or R&D Committee) or individual(s) to ensure accountability

11. 11 Local Accountability Who is Responsible? Who should be designated to provide local accountability? Medical Center Director & ACOS/R&D have ultimate responsibility Who should be designated to provide local comments to the VA Central IRB? IRB or designee R&D Committee or designee IO designee Combination of the above

12. 12 Local Accountability Local Responsibilities Providing local knowledge of Research culture Community culture & attitudes State & local laws Investigator oversight Investigator responsibilities Research misconduct/impropriety Training & credentialing Monitoring & auditing Handling of adverse events

13. 13 Ownership by Local IRBs Develop Trust Ensure quality review Leverage the respect for, & networking capabilities of, local IRBs by working closely together Create a transparent process Provide complete information, not just an approval letter Establish close communications Not just letters & emails Provide opportunities for IRB chairs & members to network, share experiences & get help from one another Local IRBs involved in multi-site studies need to be able to talk to each other

14. 14 Why the VA Central IRB Will Not Solve Everyone’s Problems Lots of other local responsibilities for HRP Other approvals (e.g., R&D Committee, animal, biosafety, radiation safety, unions, OMB) Many current delays are caused by investigators’ not providing all materials required for IRB review in a timely fashion Potential for some loss of local compliance resources

15. 15 Affiliate Relationships Current VA policy does not permit a VA IRB to serve as the IRB of record for the affiliate Duplicative review Dual appointment investigators Non-VA-funded studies (e.g., some CSP studies) Communication will be key

16. 16 Conflict of Interest Less local institutional COI Potential COI by having VA Central IRB in ORD COI cannot be completely eliminated No matter where VA Central IRB is housed (ORD, separate office reporting to USH, independent IRB), VHA will be paying for it Is it worse for an IRB to by housed by An entity that funds research? An entity that gets funds for research? Must be aware of potential COI & manage it effectively

17. 17 Communication Strategy Purpose Prepare for new VA Central IRB Ongoing communications after it is operational Targets Leadership (VACO, VISN & Medical Center Directors) Administrative officials Investigators IRB staff & members Affiliates Subjects Public Other agencies

18. 18 VA Central IRB Timeline Fall & Winter 2005-6 Site visits to NCI CIRB & Independent IRBs National IRB Workshop, November 2005 Draft policies & procedures Communications NLB Health Systems Committee, ORO, Ethics, Nursing, Patient Care Services, etc. NRAC & FRAC Spring & Summer 2006 Field Focus Group Meeting Recruit IRB Administrator & IRB Coordinator Fall & Winter 2006 Local Accountability meetings VA IRB Chairs meeting, November 15, 2006 National IRB Meeting, November 20-21, 2006 Identify & train IRB members