SYSTEM ISSUES

Data on IRB Operations

Several studies have been conducted over the past few decades on the operation of the IRB system—see, for example, Bell, Whiton, and Connelly (1998); U.S. General Accounting Office (1996); Sieber and Baluyot (1992); Cooke, Tannenbaum, and Gray (1978; see also Gray, Cooke, and Tannenbaum, 1978). It is difficult to compare the results of the different studies, and some are quite limited in sampling frame and sample size.

In order to have a richer set of data on IRB operations and to track the strengths and weaknesses of the IRB system over time, we believe there is a need for a continuing survey of IRBs, with a longitudinal component. Our recommendation pertains specifically to the need for a continuing survey of IRB characteristics and procedures with respect to SBES research. In our final report, we plan to analyze further the data from existing studies of IRBs and to provide details on the requirements for a useful data system.

Recommendation 9: OHRP and other relevant agencies, working with professional associations in the social, behavioral, and economic sciences, should develop an ongoing survey of IRB composition and practices, as an informational resource that can help assess strengths and weaknesses of the system for protecting human participants in SBES research. The design should permit analysis of review practices for SBES research by type of IRB (all fields, SBES fields only), representation of SBES expertise on IRBs, and related issues.

Accreditation

One of the major tasks of the IOM committee is to recommend standards for accrediting human research protection programs. The committee’s initial recommendations included that “[t]he first step is implementation of pilot programs to test standards, establish accreditation processes, and build confidence in accrediting organizations” (Institute of Medicine, 2001:53). We support the plan to evaluate accreditation standards through the use of pilot tests. We also agree with the committee that the accreditation process should accommodate organizations involved in research beyond the traditional academic health centers and Veterans Administration and with models other than clinical research, a position that has been adopted by the Association for the Accreditation of Human Research Protection Programs.12 However, the pilot studies that are in progress (see Institute of

12  

For more information, see http://www.aahrpp.org/principles.htm.



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