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VA Central IRB MOU Webinar

VA Central IRB MOU Webinar. K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs. Human Research Has Changed. New opportunities Electronic age Larger, more complex studies Faster translation to clinical care

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VA Central IRB MOU Webinar

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  1. VA Central IRBMOU Webinar K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs

  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, PTSD, TBI, Diabetes, etc.) • Genomics Research • Health Services Research • Cooperative Studies

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

  4. VA Central IRBLogistics • ORD studies only • ORD Service (e.g., CSP, RR&D, HSR&D, QUERI) will determine if a study should be reviewed by the VA Central IRB • VA facilities that do not use the VA Central IRB will not be able to participate in projects reviewed by the VA Central IRB

  5. VA Central IRBLogistics • No charge to the field for using the VA Central IRB • Staffed by PRIDE in ORD • Monthly meetings • Ad hoc expert advisors • VA Central IRB website

  6. VA Central IRB Reviews • Full • Expedited • Exempt • Continuing • Waiver of HIPAA-compliant authorization

  7. Updated 07/01/08 Geographical Distribution of VA Central IRB Voting Members

  8. IRB Composition • 20 members • 2 co-chairs • Mostly VA appointments • Without compensation (WOC) appointments for non-affiliated members • Compensation • @ 1/8 for members • @ 2/8 for co-chairs

  9. Nonvoting Members • Ethics • Legal • Regulatory Affairs • Privacy & HIPAA • Information Security Officer • Chief Information Officer

  10. VA Central IRBProcess • PI enlists sites • PI submits PI Application to VA Central IRB, including list of participating VA facilities • Each Local Site Investigator (LSI) submits a Local Site Application based on PI Application • Signatures • Service Chief/Director • ACOS/R&D

  11. VA Central IRBProcess • VA Central IRB performs review • Local VA facilities have 30 days to provide comments • VA Central IRB is final arbiter • Local VA facilities decide whether or not to participate • Local R&D Committee must approve before research is initiated at that facility • Other sites may be added later

  12. Federalwide Assurance (FWA) • VHA has an FWA for the VHACO Human Research Protection Program (HRPP) • Institutional Official (IO) – PDUSH • Human Protections Administrator (HPA) – CRADO

  13. Local VA Facilities • 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 VHACO • Develop SOPs for using the VA Central IRB as an IRB of record

  14. MOU Between Local VA Facility & VHACO • Memoranda of Understanding (MOUs) will be “crisp” agreements with clear delineation of respective • Roles • Responsibilities • Authorities

  15. VA Central IRBLocal 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)

  16. Local AccountabilityWho is Responsible? • The local Institutional Official (IO) is the medical center director (MCD) • MCD & ACOS/R&D have ultimate responsibility

  17. Local AccountabilityWho is Responsible? • Who should be designated to provide local accountability& to provide local commentsto the VA Central IRB? • IRB or designee • R&D Committee or designee • Other IO designee

  18. MOU Template • Cannot be modified • Webinars to guide local VA facilities

  19. Local AccountabilityLocal Roles & Responsibilities • Local knowledge of • Research culture (e.g., depth & breadth of local research program) • Research infrastructure (e.g., space, equipment, etc.) • Community culture & attitudes (e.g., ethnicity, race, language, etc.) • State & local laws (e.g., who can be legally authorized representative)

  20. Local AccountabilityLocal Roles & Responsibilities • Resources for local Research Office & HRPP • Investigator oversight • Investigator responsibilities (e.g., hiring qualified research personnel) • Research misconduct/impropriety (e.g., investigations of misconduct) • Local R&D Committee Review

  21. Local AccountabilityLocal Roles & Responsibilities • Training, credentialing & privileging, and conflict of interest (must keep documentation on file) • Monitoring & auditing of projects • Local handling of adverse events & unanticipated problems • Other reviews (e.g., local R&D Committee, IACUC, Radiation Safety, etc.)

  22. Investigator Training Webinars To review • How the VA Central IRB will work • Principal Investigator (PI) Application Form • Local Site Investigator (LSI) Application Form

  23. VA Central IRBMeasures to Ensure High Quality • Well-trained staff • Qualified IRB co-chair & members • Expert ad hoc advisors • Formal peer-reviewed evaluation • Routine ORO auditing & monitoring • AAHRPP accreditation

  24. VA Central IRBMeasures to Ensure High Quality • Work closely with • 4 ORD Services • ORO • OGC • Ethics • Privacy • OI&T • Input from other Federal agencies (e.g., OHRP, NCI)

  25. VA Central IRBAdvantages • Consistent expert ethical & scientific review • More training & experience for IRB in reviewing multi-site studies • Centralized investigator accountability • Earlier identification of trends in adverse events • Eliminates local conflict of interest • Model for local VA IRBs • More efficient IRB review of multi-site studies • Potential to facilitate translation of research

  26. Why the VA Central IRB Will Not Solve Everyone’s Problems • Lots of other local responsibilities for HRPP (as spelled out in MOU) • 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

  27. Affiliate Relationships • VA Central IRB should not affect 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

  28. Contact Information Lynn Cates, MD Assistant Chief Research & Development Officer Director, PRIDE 202-461-1811; lynn.cates@va.gov Marisue Cody, PhD Deputy Director, PRIDE 202-461-1814; marisue.cody@va.gov Annette Anderson VA Central IRB Administrator 202-461-1813; annette.anderson3@va.gov Lorna Kamber VA Central IRB Coordinator 202-461-1812; lorna.kamber@va.gov

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