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VA Central IRB Purpose

VA Central IRB Purpose. Improving veterans lives Enhancing the quality of human research protection in VA-funded multi-site studies by ensuring Expert ethical & scientific review Local issues are addressed Enhancing efficiency of IRB reviews. VA Central IRB Logistics.

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VA Central IRB Purpose

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  1. VA Central IRBPurpose Improving veterans lives • Enhancing the quality of human research protection in VA-funded multi-site studies by ensuring • Expert ethical & scientific review • Local issues are addressed • Enhancing efficiency of IRB reviews

  2. VA Central IRBLogistics • Office of Research & Development (ORD)-funded studies only • ORD funding Service will determine if a study should be reviewed by the VA Central IRB • No charge to the field for using the VA Central IRB • Staffed by PRIDE in ORD • IRB members from all over the country • Expert ad hoc advisors • Monthly meetings • VA Central IRB Web site

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

  4. IRB Composition • @ 18 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

  5. Nonvoting Members • Regulatory affairs • Legal • Privacy & HIPAA • Information security

  6. VA Central IRBProcess • PI enlists sites • PI submits protocol to VA Central IRB, including list of participating VA facilities • Each participating VA facility submits a local site application • VA Central IRB performs review • Local VA facilities provide comments

  7. VA Central IRBProcess • 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

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

  9. 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 • Combination of the above

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

  11. 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 • Gets research results to veterans faster

  12. VA Central IRBChallenges • Ownership by local IRBs • Assurance of review quality • Expectations that it will solve everyone’s problems • Affiliate relationships • Conflict of interest • Communication

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