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*170. Variation in Institutional Review Board Processes for Multicenter Focus Group Research

BJ BootsMiller, Program in Health Services Research, Iowa City VAMC; BA Sorofman, The University of Iowa College of Pharmacy; JE DeWitt, Drake University College of Pharmacy; T Tripp Reimer, The University of Iowa College of Nursing; BN Doebbeling, The University of Iowa Departments of Internal Medicine and Epidemiology; Colleges of Medicine and Public Health

Objectives: In order to conduct multicenter research, collaboration with Institutional Review Boards (IRBs) is necessary to protect human subjects. This study is part of a nationwide QUERI-funded investigation of provider and facility level factors influencing clinical practice guideline (CPG) implementation. The objective of this component is to document the variation in the process of IRB approval of focus group research within the VAMCs studied.

Methods: A purposeful sample of VAMCs was selected. Hospitals were categorized on the basis of External Peer Review Program performance indicator adherence data. Facilities were selected to represent a range of adherence, geographic location, bed-size, teaching affiliation, patient population age, ethnic distributions and VISNs. The Chief of Staff (COS) at selected facilities was contacted to request approval to conduct 3 focus groups with their employees. After COS approval, a site coordinator was identified and project information (documentation of IRB review and VA research committee approval) was provided to the research office (if applicable) to request IRB approval. The IRB at the granting facility conducted an expedited review of this research since it involved key informant interviews and focus groups, did not involve patients, retained no identifying information about participants and presented minimal risk to participants. Each site was informed about the prior review and approval by the coordinating site’s IRB and VA research committee. Data were kept on the types of documentation, types of reviews, and time to achieve approval.

Results: Fifty focus groups were conducted in 18 facilities. Involvement of an IRB in the approval process varied markedly, based on presence of a research office, medical school affiliation, and size of the medical center. Approval processes ranged from verbal approval by the administrator or research office, to requirement of additional full review. One site required written consent forms be signed by focus group participants. The IRB approval process at 2 sites required 3-4 months each, following COS approval. Since the project was part of the Quality Enhancement Research Initiative (QUERI), its role as a quality improvement project appeared to facilitate approval at some centers. Although documentation requirements varied, the most common process was for the local sites to review project summary and documentation and accept the review of the granting facility’s IRB.

Conclusions: The qualitative quality improvement research conducted in this study was low risk to participants (VA employees), however, wide variation existed in the IRB approval process. Subtle differences in facilities’ IRB procedures are understandable due to size and university medical center affiliations. However, differences ranging from no review to complete review requiring a consent form for focus group participants show considerable variation in the IRB review process throughout the VA system.

Impact: Qualitative research, even for quality improvement purposes, may be subject to IRB review, due to increased awareness of the need for protection of human subjects. There is a need to decrease system-wide variation in the IRB approval process, particularly for qualitative health services research designed to improve quality of care.