time, supplant the existing regulatory standards, with their focus on IRB structure and documentation procedures. A shift from documentation-based standards to performance-based standards could not take place quickly, but it may well become possible over time (see Recommendations 6 and 7).

External Evaluation

The accreditation programs of NCQA and AAHRPP both intend to visit every organization seeking accreditation, at least initially. The accreditors visiting sites would review the self-evaluation; view documentation; and carry out interviews of IRB staff and members, administrators, investigators, and (if the recommendations of this IOM committee are adopted) participants. The site visit is intended to give accreditors a hands-on feel for the organization and to raise questions when they can be answered directly and immediately. The accreditors would then prepare a formal written report and make their decision to accredit the applicant, give it a probationary status, or reject the application.

Launching the accreditation process is likely to encounter some capacity limits for external evaluation. The committee concurs that site visits will be necessary initially, which will limit the number of institutions that can be accredited. At the committee's December 18 open meeting, David Korn of AAMC, which is involved with helping to establish AAHRPP, estimated that AAHRPP might eventually be able to accredit as many as 650 to 700 HRPPPs, but it would take a number of years to reach this level. This is one reason that the committee believes that the accreditation process should be regarded as a pilot study rather than a fait accompli (see Recommendation 1 below).

PRIM&R does have a core set of trained IRB professionals to draw upon for the initial AAHRPP site visits. This pool is limited, however, and it would be unrealistic to expect a new accreditation organization to manage more than one or two site visits per week, on average, during its first year. The minimum of potential applicants can be estimated by the 165 institutions that registered their IRBs with the Office for Human Research Protections (OHRP) as of February 5, 2001.5 It appears likely, therefore, that it would take 2 to 3 years to accredit just those institutions that registered their IRBs in the first 2 months in which they were able to do so. It would take even longer to accredit the 491 institutions surveyed in 1995 in the most recent and extensive survey of IRB operations (Bell et al., 1998).

5  

The registration process began in December 2000. Most institutions have more than one IRB, so the number of IRBs registered is much larger than the number of potential applicant institutions.



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