Health Services Research & Development

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2007 HSR&D National Meeting Abstract

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National Meeting 2007

3067 — 46 IRB Submissions and Counting: How Variability in the IRB Review Process Impacts Multi-Site VA Health Services Research

Petersen LA (Division of Health Policy and Quality, Houston Center for Quality of Care and Utilization Studies) , Nguyen LC (Division of Health Policy and Quality, Houston Center for Quality of Care and Utilization Studies), Urech TH (Division of Health Policy and Quality, Houston Center for Quality of Care and Utilization Studies), Zimmer M (Division of Health Policy and Quality, Houston Center for Quality of Care and Utilization Studies), Alsarraj A (Division of Health Policy and Quality, Houston Center for Quality of Care and Utilization Studies), Soliz E (Division of Health Policy and Quality, Houston Center for Quality of Care and Utilization Studies), Petzel R (VISN 23 Network Director)

Objectives:
The gold standard for generalizable research is a multi-site randomized controlled trial (RCT). Such trials are relatively rare in health services research. The goal is to describe our experience with Institutional Review Board (IRB) and Research and Development (R&D) Committee reviews of a VA-funded, twelve-site RCT of an intervention to improve the quality of care for hypertension.

Methods:
Of 43 facilities in the 5 Networks, 25 met criteria for at least 8 full-time primary care physicians on-site. Of these, 3 could not participate due to lack of either an on-site or affiliate IRB relationship. Local site PIs are required prior to submission. Applications were initiated July 6, 2005.

Results:
Applications for 21 facilities were planned; in two cases, the hospital director did not wish to participate in the research, so approval was not pursued. 17 site investigators have been identified and 17 IRB applications submitted; sixteen have been reviewed. Of these, 15 required resubmission (range 1-5), for a total of 46 submissions to date. Ten of the seventeen are approved by both the IRB and local R&D committee. Two received expedited reviews. At another site, the IRB approved the protocol, but the local R&D committee disapproved it. Two IRB protocols were disapproved, with one subsequent approval on appeal; an appeal of the other is pending. The range of time between submission and full approval ranged from 28–157 days. In 4 cases, the site PIs resigned prior to or in the midst of the submission process and were replaced. For one facility, the R&D committee recommended deception for participants in the control arm to blind them to the intervention; this protocol remains under review. One facility required local union review. Two facilities required opinions regarding the legality of the intervention. One of these facilities approved the application; the other application is on hold pending legal review.

Implications:
The IRB review process is highly variable and inefficient. Furthermore, it can create unnecessary variability in study protocols across sites.

Impacts:
A centralized IRB process for VA research may avoid many of the pitfalls of multi-site IRB review and reduce the budget and delay for multi-site research.