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INTRODUCTION, BACKGROUND, AND DEFINITIONS 26 In 1979, the National Commission published The Belmont Report, which identifies three basic principles for the ethical conduct of research with human subjects: respect for persons, beneficence, and justice. In response to this report, DHHS and FDA revised their regulations, creating in 1981 the Federal Policy for the Protection of Human Subjects in Research.3 The National Commission described the then-emergent structure and function of ethics review boards at research institutions, which later became known as institutional review boards (IRBs). IRBs became the roof beam in the framework for the protection of the rights and interests of human participants in research and remain so today. In 1981, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (the President's Commission) was established. Two of its reports focused on the system of protection of human participants in research (President's Commission, 1981, 1983). In Implementing Human Research Regulations, the President's Commission recommended that, âThere should be a uniform Federal system documenting the implementation of the regulations through prior assurance and periodic site visitsâ (President's Commission, 1983, p. 3). Eventually, the federal government would attempt to standardize the human subjects regulations across agencies and departments. In 1991, the regulations, now known as the âCommon Ruleâ (Subpart A, 45 CFR 46), were simultaneously published in the Federal Register by 15 departments and agencies. By 2001, 18 agencies have adopted the Common Rule, and numerous additional international documents and guidelines have been developed and revised (see Box 1-1). The regulations used across the federal government prescribe requirements for research involving human subjects, including the functions, operations, and compositions of IRBs; IRB review of research; record keeping; and requirements for informed consent. MORE RECENT EVENTS Advisory Committee on Human Radiation Experiments In 1993, the nation was shocked by a series of news articles in the Albuquerque Tribune that revealed experiments involving injection of plutonium into humans. This touched off national press coverage and subsequent revelations about Cold War-era radiation experiments conducted with civilian and military populations. In response, President Bill Clinton established the Advisory Committee on Human Radiation Experiments (ACHRE) to investigate reports of federally sponsored human research involving radioactive materials conducted 3 45 CFR 46; the FDA regulations are at 21 CFR 50, 56.
INTRODUCTION, BACKGROUND, AND DEFINITIONS 27 BOX 1-1 RELEVANT INTERNATIONAL CODES Research is a global enterprise. U.S. commissions have built on and worked in parallel with codes developed elsewhere in the world, some of which also set a context for the present committee's work. Several international codes articulate principles for the ethical conduct of research. The Declaration of Helsinki is perhaps the best known among these. In its current form, the declaration contains 32 statements of principle to guide medical research. Its conceptual foundation is the medical ethics of the doctor-patient relationship, and this is extended to medical research via an investigator-subject relationship. The declaration opens with general statements of moral norms, the duties of physicians, and the subordinate role of science when it comes into conflict with the human rights of human subjects, followed by sections on research per se and research combined with medical care. The Council for International Organizations of Medical Sciences (CIOMS) prepares the International Ethical Guidelines for Biomedical Research Involving Human Subjects. The first CIOMS guidelines were published in 1982, followed by revision in 1993, and they are again being revised, with public release expected in the next year (CIOMS, 1982, 1993). The International Conference on Harmonisation has developed detailed guidelines specific to drug trials and for good clinical practice (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996, 1997) and many other guidelines on other aspects of testing of pharmaceutical products. The International Conference on Harmonisation was formed in 1990 and involves government agencies and pharmaceutical trade organizations from the European Union, Japan, and the United States (International Conference on Harmonisation, 1998). Its guidelines are not just for research that crosses national borders but, in fact, constitute guidance for trials of any size and are recognized formally by the Food and Drug Administration. Several governments, including those of India and Canada, have prepared guidelines for research that are recognized by the U.S. Office of Human Research Protections (CECHR, Indian Council of Medical Research, 2000; NSERC, 2000; OHRP, 2000a). The Indian Council of Medical Research guidelines apply to biomedical research, and the Tri- Council Statement from Canada applies to research under the Natural Sciences and Engineering Council, the Social Sciences and Humanities Research Council, and the Institutes of Health Research.
