2069. Managing IRB Reviews for a Nationwide Study
ND Sharp, HSR&D Center of Excellence, Puget Sound Health Care System, and Department of Health Services, University of Washington, Seattle, AE Sales, HSR&D Center of Excellence, Puget Sound Health Care System, and Department of Health Services, University of Washington, Seattle

Objectives: The HSR&D-funded Nurse Staffing and Patient Outcomes in VA study includes a survey of clinical nursing staff in VA hospitals and extraction of patient outcomes data from national VA administrative databases. Our objectives for the initial six months of the project were to obtain necessary approvals from local Institutional Review Boards and Research & Development Committees to administer the nursing staff survey at VAMCs nationwide.

Methods: We prepared a consultation packet that included the complete HSR&D grant submission, the approved application to our home IRB, and email correspondence with VAs Office of Research Compliance and Assurance and Office of Research and Development. Our initial telephone contacts with facilities determined that 21 hospitals were part of multi-site health care systems with consolidated review functions and 26 VAMCs did not have local IRBs for project review. We emailed or mailed the consultation documents to Research Coordinators or Compliance Officers at the remaining VAMCs with a request for advice on required reviews at their facility. Documents were sent during the first week of August 2002.

Results: Of the 111 facilities that received a consultation request, 18 determined on the basis of the documentation provided that the project required no local IRB review. An additional ten facilities requested and approved a formal application for exemption from IRB oversight. Nine IRBs reviewed and approved the project based on the submitted documentation, and 43 facilities required an application to the IRB sponsored by a local Principal Investigator. One facility declined to review. Two months after submission of the initial documents packet, 30 facilities have not responded to the request for consultation.

Conclusions: Local review requirements and interpretation of federal regulations regarding human subjects protection vary widely across VAMCs. The same project protocol was interpreted by local reviewers as exempt from IRB review, eligible for expedited review, and requiring full IRB review and local oversight.

Impact: Disparities in compliance processes and interpretation of regulatory requirements across VAMCs place a significant burden on multi-site research projects. In addition, veteran and staff subjects may not receive equivalent oversight and review across the VA healthcare system.