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EXECUTIVE SUMMARY 20 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
EXECUTIVE SUMMARY 21 recommendations according to the three phases intrinsic to the implementation of an accreditation process: development of the program, development of standards, and evaluating the program. First, to develop the accreditation program, accreditation of HRPPPs should be pursued through pilot programs as one method to enhance the overall protection of participants taking part in research. This effort should be led by nongovernmental accreditation bodies with both the responsibility and the authority to craft and implement accreditation standards. Maintenance of these tasks within one or a few independent entities allows data collection and the experience gained through the process of accreditation to be tethered tightly to the timely evolution of standards. Further, any accreditation standards must encompass an assessment of participant involvement in local research oversight, greater specificity about the responsibilities of research sponsors, and integration of research monitoring, professional education, and quality improvement into the oversight system. Second, with respect to the development of accreditation standards, the committee believes that the NCQA draft standards should be adopted as a starting point. They will, however, require modification to include the components in Recommendation 9 and to accommodate disparate research environments and disciplines. This recommendation stems from the NCQA standard's explicit underpinning in federal regulations, their reliance upon rigorous quality improvement programs, and the resulting potential to move from a system overly focused on administrative compliance to one that emphasizes flexibility in achieving protection of participants in research. Finally, efforts to evaluate the ability of accreditation programs to improve HRPPP function (i.e., ensure participant protection) should begin now. The committee suggests two complementary strategies: 1) data collection to assess systemic improvement over time; and 2) independent, comprehensive analysis of the effectiveness and relative cost of accreditation programs in achieving desired outcomes. These recommendations are intended to guide the federal government and research entities in their immediate efforts to ensure that high-quality, innovative research never sacrifices the rights and safety of those individuals who voluntarily assume the risks inherent in research with humans.
EXECUTIVE SUMMARY 22 BOX 1 SUMMARY OF COMMITTEE'S RECOMMENDATIONS ACCORDING TO THE THREE IMPLEMENTATION PHASES OF AN ACCREDITATION PROCESS Development of an Accreditation Program: Pursue Accreditation Through Pilot Testing as One Approach (Recommendation 1) Establish (a) Nongovernmental Accreditation Organization(s) (Recommendation 2) Accommodate Distinct Research Methods and Models Within Accreditation Programs (Recommendation 5) Directly Involve Research Participants in Accreditation Programs & HRPPPs (Recommendation 8) Development of Standards: Articulate Sound Goals Within Accreditation Standards (Recommendation 3) Establish Flexible, Ethics-Based, and Meaningful Standards (Recommendation 4) Base Standards on Existing Regulations (Recommendation 6) Incorporate Continuous Quality Improvement Mechanisms into Standards (Recommendation 7) Use Modified NCQA Standards to Initiate Pilot Programs (Recommendation 9) Development of an Evaluation Process: Begin Collecting Data and Assessing Impacts of Accreditation Now (Recommendation 10) Initiate Federal Studies Evaluating Accreditation (Recommendation 11)
