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INTRODUCTION, BACKGROUND, AND DEFINITIONS 24 the accreditation of programs that are charged with the responsibility of protecting individuals who volunteer for research. This first chapter provides the relevant background preceding this work, as well as discussion pertaining to the committee's concept of a human research participant protection program (HRPPP) and related terminology. Chapter 2 explores various models of accreditation. It also focuses on how accreditation might apply to activities surrounding protection of human research participants and explores the process for such a system. Chapter 3 centers on the issue of standards; that is, what values and measurements should be used to address an organization's level of performance and expectations for activities that affect the protection of participants in human research? In response to its charge, the committee reviewed the draft Public Responsibility in Medicine and Research (PRIM&R) standards and those developed by the National Committee for Quality Assurance (NCQA). Chapter 3 presents the committee's recommendations about standards for accreditation. Chapter 4 focuses on issues in evaluating and analyzing a system of accreditation. In response to the committee's third task, this chapter includes committee recommendations for steps that the federal government should take to collect and analyze data that can be used to monitor and evaluate how well the system for protecting human research participants is operating. A SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATES In response to the atrocities committed by Nazi scientists during World War II, the Nuremberg Military Tribunal created the Nuremberg Code, a set of 10 principles for research involving human participants, including an absolute requirement for voluntary consent (Nuremburg Code, 1946â1949; United States v. Karl Brandt et al. The Medical Case 1946â1949). The Nuremberg principles placed primary responsibility on the investigator to ensure that research was ethically conducted. At the same time that the Nuremberg Trial was proceeding, anticipating the need for a rapid response to concerns about research abuses, the American Medical Association adopted its first code of research ethics for physicians in 1946, outlining principles to be followed in conducting research with human subjects (AMA Judicial Council, 1946). Over the ensuing two decades, U.S. policy in this area evolved, addressing prohibitions on research involving vulnerable or special populations and eventually requiring independent review of research and written consent for âhazardousâ research (ACHRE, 1995). The Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act required the Food and Drug Administration (FDA) to evaluate new drugs for safety as well as efficacy, significantly expanding the power of the federal government to influence the conduct of clinical
INTRODUCTION, BACKGROUND, AND DEFINITIONS 25 trials in particular.1 One of the provisions of this act required the informed consent of participants in the testing of new drugs. The federal policies were slowly moving away from reliance on the investigator as the sole focus of decision making about ethical research and more toward a policy that required independent review of research and retrieval of voluntary informed consent. This meant that the responsibility, although still on the investigator, was also being placed on the institutions that support and conduct research. By the 1960s, however, few research institutions had in place a system for protecting research subjects, despite requests by the National Institutes of Health (NIH) that they do so (Faden and Beauchamp, 1986). A 1966 U.S. Public Health Service (PHS) policy required independent review of research by a committee of the investigator's âinstitutional associatesâ (PHS, 1966). Later, NIH would create the Office for Protection from Research Risks (OPRR) and take the lead in the protection of research subjects in research conducted or sponsored by the U.S. Department of Health and Human Services (DHHS). The need for enhanced efforts to protect research subjects was underlined in 1966 when Henry Beecher published an article presenting 22 examples of âunethical or questionably ethical studiesâ that had appeared in mainstream medical journals (Beecher, 1966). One of these studies involved injection of the hepatitis virus into children seeking admission to the Willowbrook State School for the Retarded in New York. Although parental consent was obtained, it was likely uninformed and certainly suspect because of undue influence, that is, concerns of parents that their children could not be enrolled in the school if they refused to participate (ACHRE, 1995). Then, in 1972, details emerged about the Tuskegee Syphilis Study, begun in the 1930s (Heller, 1972). The study attempted to trace over several decades the natural history of syphilis in poor, African-American males living in Alabama. Not only were the participants not told the purpose of the study, but they were also led to believe that they were receiving treatment (Gamble, 1997; Heller, 1972; Jones, 1981). PHS deemed the study unethical and stopped it, offering the surviving participants antibiotic treatment. A PHS advisory panel reviewing the Tuskegee study determined that existing procedures for the protection of research subjects were inadequate and that the U.S. Congress should establish a âpermanent body with the authority to regulate at least all federally supported research involving human subjectsâ (Tuskegee Syphilis Study Ad Hoc Advisory Panel, 1973, p. 23). Subsequent congressional hearings led to passage of the National Research Act, which established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission) to provide analyses of the ethics and policies related to the conduct of research with human subjects.2 1Federal Food, Drug, and Cosmetic Act of 1938. P.L. 75-717, 52, Stat. 1040, as amended 21 U.S.C. 31 et seq. 2 National Research Act of 1974. P.L. 93-348 (1974).