VA Central IRB

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. VA Central IRBPurpose • 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. VA Central IRBExamples of Research Projects • Quality Improvement & Organizational Research • Database Research • Nursing Research • Cooperative Studies • Genomics Research

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

6. VA Central IRBProcess • 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. 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. VA Central IRBAdvantages • 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. VA Central IRBChallenges • 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. 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. Local AccountabilityWho 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. Local AccountabilityLocal 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. Ownership by Local IRBsDevelop 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. 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. 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. 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. 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. VA Central IRBTimeline • 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