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The VA Central irb opportunities and challenges

Explore the history, purpose, and operations of the VA Central IRB, and learn about the challenges faced in improving human research protection in multi-site studies. Discover the support provided to IRB Chairs and the opportunities for enhancing efficiency in IRB review.

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The VA Central irb opportunities and challenges

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  1. The VA Central irbopportunities and challenges Stephen Bartlett, RPh, MSPH Denver, CO Robert Hierholzer, MD Fresno, CA

  2. Outline of Presentation • History and purpose of the VA Central IRB • VA Central IRB Operations • Challenges • Support for IRB Chairs

  3. Creation of the VA Central IRB • Primary Purpose • Improve human research protection in VA multi-site studies by ensuring • Consistent expert ethical & scientific review • Local issues are addressed • Secondary Purpose • Enhance efficiency of IRB review

  4. Opportunities “In response to these various criticisms, we propose changes to the following seven aspects of the current regulatory framework. The fundamental goal is to enhance the effectiveness of the research oversight system by improving the protections for human subjects while also reducing burdens, delays, and ambiguity for investigators and research subjects…. 2. Utilization of a single IRB review of record for domestic sites of multi-site studies (Section III)…”From Federal Register, Advance notice of proposed rulemaking, Vol 76, Number 143

  5. Projects Reviewed by the VA Central IRB • All new multi-site studies funded by the VA Office of Research and Development • Clinical Sciences Research and Development • Cooperative Studies Program (CSP) • Health Services Research and Development (HSR&D) • Quality Enhancement Research Initiative (QUERI) • Rehabilitation Research and Development

  6. VA Central IRB Membership and Staff • 16 Voting members • Non-Voting members • Ethics • Legal Affairs • Regulatory Affairs • Information Security • Privacy • Staffed by Program for Research Integrity Development & Education (PRIDE)

  7. VA Central IRB Operations • Monthly meetings in person, with mid-cycle phone meeting • Reviews conducted: convened board, expedited, exempt, continuing reviews, waiver of HIPAA authorization • Two types of applications • Principal Investigator (PI) Application • Local Site Investigator (LSI) Application

  8. Initial Review Process • Approval of PI application or approved contingent on minor modifications, then • A copy of the approved PI application is sent to each local site for review while • Local site investigators (LSIs) prepare LSI applications • Each local site has 15 days to provide comments to the VA Central IRB • No requirement for the local IRB of record to review the project

  9. Additional Opportunities • Awareness of problems common to local sites in the conduct of a project • Raise awareness of variations in local practice

  10. Challenges • Encouraging discussion, yet staying within time limits • Blending of IRB cultures • Overcoming “remoteness”: We are not “down the hall.” • Misperception that we are “Central Office” • Realizing goal of uniformity across sites, while respecting local site issues

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