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INTRODUCTION, BACKGROUND, AND DEFINITIONS 28 between 1944 and 1972. ACHRE's work is a direct precedent to several current activities. As part of its charge, ACHRE also assessed the current state of protections for research subjects. In its final report, ACHRE concluded that it had found âevidence of serious deficiencies in some parts of the current systemâ (ACHRE, 1995, p. 797). In particular, ACHRE cited variability in the quality of IRBs, confusion on the part of research participants about whether they were to receive therapeutic benefit from volunteering for studies, and concern about the adequacy of the consent process. ACHRE urged that (1) federal oversight of human subject protections focus on outcomes and performance rather than paperwork reviews and intermittent audits for cause, (2) sanctions for violation be authorized and be in proportion to the seriousness of the violation, and (3) protections be extended to research that is not federally funded. A study commissioned by NIH and published after release of the ACHRE report corroborated many of the ACHRE committee's findings. The study was based on a survey of IRBs and investigators at research institutions holding a federal assurance agreement with NIH. It found that an estimated half million people were involved in research under IRB-reviewed protocols and that the number of protocols had more than quadrupled in the two decades since the National Commission had last surveyed IRBs (Bell et al., 1998). That report concluded that the system of protection was by and large functioning adequately, but it did point to a mounting workload and the intermittent emergence of research scandals. ACHRE also called for the creation of a national commission âto provide for the continuing interpretation and application of ethics rules and principles for the conduct of human subject research in an open and public forumâ (ACHRE, 1995, p. 821). President Clinton's executive order creating the National Bioethics Advisory Commission (NBAC) implemented this recommendation.4 The National Bioethics Advisory Commission NBAC was established by executive order in October 1995 and was asked by President Clinton to look into the protection of human subjects in research, with âprotection of the rights and welfare of human research subjectsâ listed as its first priority (Clinton, 1995). As one of its first actions, in May 1997 NBAC unanimously resolved that âno person in the United States should be enrolled in research without the twin protections of informed consent by an authorized person and independent review of the risks and benefits of the researchâ (NBAC, forthcoming-b, p. 26). NBAC issued subsequent reports on research involving those with impaired decision-making capacity (NBAC, 1998), research using human biological materials (NBAC, 1999a), and ethical issues in human stem 4NBAC's establishment was also a culmination of long-standing interest in a bioethics commission among members of Congress, such as Senators Mark Hatfield and Edward Kennedy and Rep. Henry Waxman, as well as a 1993 congressional report and the President's Science Advisor, John H. Gibbons (OTA, U.S. Congress, 1993).
