to them, and what forms of informed consent are most effective. Several new initiatives to enhance clinical research in particular are under way, and the National Institutes of Health has initiated new programs to improve research monitoring. DHHS should evaluate these efforts not only for their primary purpose of improving clinical research but also for how they can improve HRPPPs.

Recommendation 11: Initiate Federal Studies Evaluating Accreditation

The U.S. Congress should request an evaluation of accreditation pilot programs from the General Accounting Office. The Secretary of Health and Human Services should consider requesting a parallel evaluation from the Office of the Inspector General of DHHS.

An evaluation process that is independent of AAHRPP, NCQA, and other accreditation bodies can help policy makers decide on the value of accreditation as an improvement strategy several years hence. Without such an evaluation, Congress and the executive branch will be positioned little better than they are today to make prudent choices about how to improve HRPPPs in 5 years. Research pursued under Recommendation 10 can provide some baseline information, but it cannot substitute for a thorough evaluation of the accreditation pilot projects themselves. Furthermore, the evaluation efforts would benefit in several respects if they were initiated soon, while the pilot projects are getting under way. Evaluators could observe which organizations seek accreditation and which ones do not. They could also conduct interviews with organization officials who are making a particular choice to find out why and what they perceive the benefits or problems of HRPPP accreditation programs to be. If multiple accreditation bodies emerge, the evaluation should compare their effectiveness.

The HRPPP accreditation process should be evaluated not only according to whether it has improved protections for human research participants but also according to whether resources devoted to accreditation could be spent to equal or better effect on other ways to improve HRPPP oversight such as education, research monitoring, and improved feedback mechanisms. Evaluation should take into account both the costs of establishing a national accreditation system and the costs to applicant organizations. The costs to applicant organizations will include direct costs for the accreditation process and also costs for the preparation for and following up on the accreditation process.

CONCLUDING REMARKS

In summary, the committee has addressed through its recommendations what it believes are the fundamental components necessary to initiate and effectively utilize an accreditation process and a set of accreditation standards to enhance participant protection in human research. Box 1 presents the committee's



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