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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs.


Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Subjects.


Washington (DC): National Academies Press (US); 2001.
The National Academies Collection: Reports funded by National Institutes of Health.


In response to a request from the Secretary of Health and Human Services, the Institute of Medicine formed the Committee on Assessing the System for Protecting Human Research Subjects to conduct a two-phase study to examine how to improve the structure and function of human research review programs. This report provides the committee's response to the tasks in phase 1. With respect to human research review programs, those tasks are to review and consider proposed performance standards, recommend standards for accreditation, and recommend an approach to monitoring and evaluating the system for protection of human research participants. The committee reviewed and considered available draft standards developed independently by Public Responsibility in Medicine and Research (PRIM&R) and the National Committee for Quality Assurance (NCQA), which is under contract to the U.S. Department of Veterans Affairs (VA). The committee provides a series of findings and recommendations for using performance standards to improve the system for protection of human research participants. The committee finds that the standards proposed by NCQA for VA facilities appear promising for use in the accreditation of VA facilities. The committee regards the standards prepared by NCQA to be more suitable than those prepared by PRIM&R for not only pilot testing in VA facilities but also, with modification, for the accreditation of other research institutions. The NCQA standards are the strongest basis for use in the accreditation of other research institutions because they pay specific attention to quality improvement, provide flexibility in achieving performance goals (e.g., increased protection of research participants), and are explicit in their grounding in current regulations. The committee recommends that pilot accreditation programs should start from the accreditation standards and processes proposed by NCQA for VA facilities and be adapted for use in other organizational contexts by NCQA or other accreditation bodies. In expanding the draft NCQA accreditation standards for use beyond VA facilities, the committee recommends that the standards be strengthened in several specific ways. These include how investigators will be reviewed, beyond the review of protocols by institutional review boards; how sponsors will be assessed; how participants will be involved in setting performance standards; and how oversight mechanisms can ensure participants' safety. The committee further recommends that (1) the organizations formulating accreditation standards and carrying out the accreditation process be independent, nongovernmental organizations; (2) the formulation of accreditation standards, the accreditation process, and human research participant protection program operations directly involve research participants; and (3) the accreditation process accommodate organizations involved in research beyond the traditional models of academic health centers and VA facilities and be appropriate for research methods other than clinical research. Only by experience gained through pilot testing can the value that accreditation adds to the current regulatory system, in terms of enhanced protection of human research participants, be adequately assessed.

Copyright © 2001, National Academy of Sciences

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