1. The VA Central irb opportunities 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