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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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INTRODUCTION, BACKGROUND, AND DEFINITIONS 32 the federal regulations and relevant international guidelines are sufficient. These observers argue that what is needed are more resources devoted to IRBs and regulatory agencies to ensure that protections are in place (Amdur, 2000; Snyderman and Holmes, 2000; Sugarman, 2000). In 1999 and 2000, several groups moved forward with plans to develop standards for accreditation of IRBs and human research protection programs. These initiatives have come forward largely from two groups: one spawned from the PRIM&R effort and the other developed through a contract between NCQA and the VA. The origins of both are discussed in Chapter 2. STATEMENT OF TASK In October 2000, the Secretary of HHS asked the IOM to conduct a two-phase study to address three interrelated topics involved in the protection of human research subjects. The three topics are (1) accreditation standards for HRPPPs8, (2) the overall structure and functioning of activities for the protection of human research subjects, including but not restricted to IRBs, and (3) criteria for evaluation of the performance of activities for the protection of human research subjects. The IOM response is being conducted in two phases. Phase 1, the subject of this report, focuses on accreditation standards for HRPPPs. The specific tasks for phase 1 are to 1. review and consider proposed HRPPP performance standards; 2. recommend standards for accreditation of HRPPPs, considering measures of structure, process, and performance, as well as resource sufficiency; and 3. recommend steps that the organizations and institutions conducting research and the federal government should take to collect and analyze data to monitor and evaluate how well the system for protecting human subjects is operating. Phase 2 will continue the 24-month study of the structure, function, and performance of activities for the protection of human research subjects.9 The results of this future work will be presented as a separate report. DEFINITIONS In this section on definitions, the committee wishes to clarify its choice of terms to avoid confusion within this report and also to signal its awareness of the 8 In the course of committee deliberations, the term “human research participant protection program” was substituted for “human research review program” as the former term better reflected the system of oversight that the committee hopes will result from its recommendations. 9 For more information see http://www.iom.edu/hrrp.

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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