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Suggested Citation:"A CALL FOR ACCOUNTABILITY." 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 31 participants' consent, leading to congressional hearings and a subsequent change in VA policies (see below) (U.S. House of Representatives, Committee on Veterans Affairs, 1999). The Death of Jesse Gelsinger Attention was already focused on the protection of human research participants when 18-year-old Jesse Gelsinger died in a phase I gene transfer study at the University of Pennsylvania in September 1999. He was a relatively healthy (i.e., medically stable) young adult with a genetic condition—ornithine transcarbamylase deficiency—who had suffered intermittent health crises because of his condition throughout his life but who was doing relatively well on medications when he entered the gene transfer trial (Gelsinger, 2000; Lehrman, 2000a,b). The details of the case are complex and to some extent contested. Although Gelsinger was aware that he was in a gene transfer study, the FDA found that the consent form had been altered from that which had been approved and that data relevant to safety had not been reported. Questions were raised about whether some patients in the trial, including Gelsinger, fit the revised inclusion criteria and whether the IRB and relevant federal agencies were notified of adverse events that had occurred in studies with animals and in previous patients (Weiss and Nelson, 1999). The Gelsinger case was heavily reported in the national media and drew the attention of clinical investigators and research administrators throughout the world. It also became the focus of a Senate hearing and commanded direct attention from the Secretary of HHS, who subsequently requested the Institute of Medicine (IOM) study presented in this report (see discussion below) (Shalala, 2000; U.S. Senate, Subcommittee on Public Health, Committee on Health, Education, Labor, and Pensions). Problems with the system of protections for those participating in research were already apparent in 1999, but the Gelsinger death brought a sharp escalation in attention because it resulted from the experimental intervention and failures in the system of protections more than his underlying condition. A CALL FOR ACCOUNTABILITY The events of the 1990s that led to this report continuously highlighted the need for reform of the system of protections for humans involved in research. The rapid growth in the size of the research enterprise, the constant innovations in experimental tools and approaches, and growing demands on the review process from the public and research sponsors alike led PRIM&R and others to ask whether improvements could be gained by the establishment of standards for systems for the protection of humans, accompanied by a method for the measurement of compliance. Others argue that current ethical principles codified in

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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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