Health Services Research & Human Subjects Protection

1. Health Services Research & Human Subjects Protection K. Lynn Cates, MD Assistant Chief Research & Development Officer Director, PRIDE Office of Research & Development Department of Veterans Affairs February 23, 2007

2. Human Research Has Changed • New opportunities • Electronic age • Larger, more complex studies • Faster translation to clinical care • New risks • How can we meet your needs?

3. Health Services Research & Human Subjects Protection - Perceptions • What we hear from HSR&D investigators about IRBs • Reviews are inconsistent • Too slow & inefficient – unnecessary delays • Too demanding • Requirements are not realistic • Demands compromise study design • Over-estimate risks

4. Health Services Research & Human Subjects Protection - Perceptions • What we hear from IRBs about HSR&D investigators • Don’t understand when they need IRB approval or informed consent • Protocols don’t provide adequate information to assess human subjects issues • Under-estimate risk

5. Ultimate Goals • Teamwork (e.g., PIs, ORD, ORO, ISOs, Privacy, Police/Security, unions, etc.) • Define the issues (not just perceptions) • Develop informed guidance for investigators, IRBs and others responsible for protecting subjects

6. Meeting Challenges to HSR&D Investigators for Human Subjects Protection • VA Central IRB • Key issues • Defining risks (e.g., to privacy – de-identification) • When is it research vs. QI or program evaluation • Dealing with large, complex studies • Engagement - Which IRBs need to approve a multi-site study? • Data security & confidentiality • HSR&D investigator’s perspective

7. VA Central IRBPurpose • Improve human research protection in VA-funded multi-site studies by ensuring • Appropriate ethical & scientific review • Local issues are addressed • Enhance efficiency of reviews

8. VA Central IRBExamples of Research Projects • Health Services Research • Quality Improvement • Database Research • Nursing Research • Cooperative Studies • Genomics Research

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

10. VA Central IRBLogistics • No charge to VA facilities • Staffed by PRIDE in ORD • IRB members from all over the country • Monthly meetings • Evaluate performance

11. VA Central IRBProcess • PI enlists sites • PI 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 opt in

12. VA Central IRBAdvantages • More consistent expert ethical & scientific review • Earlier identification of trends in adverse events • Improved veterans’ access to multi-center trials • Improved efficiency • Transparent, consistent process • Model for local IRBs

13. Challenges for VA Central IRBLocal Accountability • Concept of “IRB” vs. “Human Research Protection Program” (HRPP) • Every facility that performs human research has ultimate responsibility for its HRPP, even if it uses another facility’s IRB or the VA Central IRB • Medical Center Director must designate someone (e.g., IRB, R&D Committee or an individual) to ensure accountability

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

15. Memorandum of Understanding (MOU) Between Local Facility & VA Central IRB • “Crisp” agreements with clear delineation of respective • Roles • Responsibilities • Authorities

16. Challenges for VA Central IRBIt Will Not Solve Everyone’s Problems • Other approvals -R&D Committee, IACUC, biosafety, unions, OMB • Many current delays are caused by investigators’ not promptly providing all information needed for IRB review

17. Preparing for the VA Central IRB • Site visits to NCI CIRB & independent IRBs • National IRB workshops on alternatives to current IRBs • Communications • NLB Health Systems Committee, ORO, Ethics, Nursing, Patient Care Services, Public Health, etc. • Field focus group • 4 regional Local Accountability meetings • VA IRB Chairs meeting • New staff: IRB Administrator & IRB Coordinator • Identify & train IRB members

18. Contact Information lynn.cates@va.gov