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VA Central IRB

VA Central IRB. K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs April 23, 2009. VA Central IRB Purpose. Improve human research protection in VA multi-site studies by ensuring

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VA Central IRB

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  1. VA Central IRB K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs April 23, 2009

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

  3. VA Central IRBLocal 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 VA Central Office

  4. VA Central IRB &Local Human Research Protection Program • Concept of “Local Accountability” • 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)

  5. Local AccountabilityLocal Roles & Responsibilities in MOU • Local knowledge of • Community culture & attitudes • State & local laws • Local investigator oversight • Training & credentialing

  6. VA Central IRB Composition • 20 voting members (2 co-chairs) • 5 nonvoting members • Ethics • Legal Affairs • Regulatory Affairs • Privacy & HIPAA • Information Security

  7. VA Central IRBApplication Process • 2 kinds of applications • Principal Investigator (PI) Application • Local Site Investigator (LSI) Application

  8. VA Central IRBProcess • PI enlists sites • PI submits PI Application to VA Central IRB, including list of participating VA facilities

  9. VA Central IRBApplication Process • After the PI application is approved by the VA Central IRB, or approved contingent upon minor modifications • A copy of the approved PI Application packet is sent to each local site • Each local site* has 30 days to provide comments to the VA Central IRB *The local IRB does not have to be involved

  10. VA Central IRBLSI Application Process • Each Local Site Investigator (LSI) prepares a Local Site Application based on PI Application • The PI reviews all LSI Applications for consistency • The VA Central IRB will require a justification for any differences among the LSI Applications (including informed consent forms)

  11. VA Central IRBProcess • VA Central IRB reviews all LSI Applications & all local comments • VA Central IRB is final arbiter

  12. Contact Information Lynn Cates, MD (202) 461-1811 lynn.cates@va.gov

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