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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
tion is having measurable impacts (e.g., by comparing accredited and nonaccredited institutions or by comparing institutions before and after accreditation).
Other studies are also needed to bolster the nascent literature on how well research participants understand the studies that they join, which risks matter most 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.
The research pursued under this recommendation should have several uses. It will provide essential data on which to base policy decisions in the future. It will also point to ways in which the system can be improved. It may help assign priorities among strategies to improve the HRPPP system by pointing to strengths and weaknesses in the current system. It is likely to uncover and document problems in the current system, some of which are already known and perhaps others of which are not fully appreciated. Finally, it could reassure the public and policy makers about those aspects of the current system that are functioning well.
Recommendation 11: Initiate Federal Studies Evaluating Accreditation
The U.S. Congress should request an evaluation of accreditation pilotprograms from the General Accounting Office. The Secretary of Healthand Human Services should consider requesting a parallel evaluationfrom 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 choices to find out why a particular choice was made 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 evaluation methods are likely to be primarily qualitative, supplemented where possible by quantitative data. Interviews, surveys, “shadowing ” of IRB staff and accreditation site visit teams, and other methods used while the pilot