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Suggested Citation:"ABSTRACT." 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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Suggested Citation:"ABSTRACT." 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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Suggested Citation:"ABSTRACT." 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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Page 3
Suggested Citation:"ABSTRACT." 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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EXECUTIVE SUMMARY 1 Executive Summary ABSTRACT 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

EXECUTIVE SUMMARY 2 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. Beginning in the 1960s, a formal system for ensuring the ethical conduct of research with humans developed in the United States. This system traditionally centered on the institutional review board (IRB). However, the Committee on Assessing the System for Protecting Human Research Subjects and others now envision a broader system with multiple functional elements that will be referred to in this report as human research participant protection programs (HRPPPs) (Figure 1). That system is the central element for protecting the interests of those who participate in research, and it has four principal functions: (1) to ensure that research design is sound and that a study's promise for augmenting knowledge justifies the involvement of human participants,1 (2) to assess the risks and benefits independently of the investigators who carry out the research; (3) to ensure that participation is voluntary and informed; and (4) to ensure that participants are recruited equitably and that risks and benefits are fairly distributed. 1See Chapter 1 for discussion regarding the committee's use of the term “participant” versus “subject.”

EXECUTIVE SUMMARY 3 FIGURE 1 Human research participant protection programs. The components in the large box are all parts of an HRPPP. Arrows represent information flow pathways, not organizational responsibilities. All units within an HRPPP should have formalized communication procedures.

EXECUTIVE SUMMARY 4 When the original system for the protection of human participants in research was created, the typical study was done at a single research institution by a single investigator or a small team of investigators. IRBs2 were formed to ensure an independent review of proposed research by volunteers at individual sites and remain the centerpiece of HRPPPs. Today, however, some clinical trials involve scores or even hundreds of centers and tens of thousands of participants. With the dramatic increase in privately funded research, a separate system of independent IRBs has also been created; such IRBs typically have professional staff, and their members are often paid for their time and effort. The review system as a whole, however, has not transformed or adapted to the vast growth in the scale and complexity of research. Research carries with it inherent risk, but it must always be conducted so that risk to research participants is reduced to the minimum necessary and the rights of the volunteers who participate in the research are respected by the entire system of research sponsors, institutions, and investigators (the HRPPP). Trust in the human research enterprise, embodied in an individual consenting to participate in a study, demands that the system responsible for protection be credible and accountable. Yet, the repeated documentation of serious strains on the system has not led to discernible improvement as weaknesses and lapses continue to come to light. The need to improve HRPPPs has become ever more apparent as report after report highlighting mounting concerns about the ability of HRPPPs to keep up with the evolving research enterprise has been issued (see Chapter 1 and Chapter 2). Nearly all of these reports have recommended a reexamination and modernization of the system. In addition, beginning in May 1999, the federal Office for Protection from Research Risks (OPRR) and the Food and Drug Administration (FDA) took action against several major research universities, suspending their human research programs because of apparent noncompliance with federal regulations. In September 1999, Jesse Gelsinger, an 18-year-old research volunteer, died in a gene transfer trial not because of his underlying disease but because of the experimental intervention itself. As the circumstances and events leading up to his death emerged, it became apparent that the system intended to protect him from unacceptable risks in research instead failed him. In response to these and other events over the last several years, the U.S. Congress, the U.S. Department of Veterans Affairs (VA), and the U.S. Depart 2 IRBs are defined in federal regulations governing human research (45 CFR 46.107– 109; 45 CFR 56.102 (g)). Food and Drug Administration (FDA) regulations cover “independent” IRBs that review privately funded research. The majority of IRBs operate under one or both sets of federal regulations. Some nongovernmental organizations have formed groups to review and approve research that is not subject to federal regulation. These groups can perform the functions of an IRB overseen by FDA or the Office for Human Research Protections (OHRP) but do so outside the purview of FDA and OHRP.

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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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