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The Department of Health and Human Services (HHS or Department) is amending the HHS policy for the protection of human research subjects and responding to the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission) concerning institutional review boards (IRBs).
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The Department of Health and Human Services (Department or HHS)( is prescribing additional requirements for protection of children involved as subjects in research. These regulations adopt, with some changes, the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) as were presented in the notice of proposed rulemaking (NPRM) 43 FR 31786 which preceded this final rule. Specifically, these regulations impose certain added responsibilities on Institutional Review Boards (IRBs) depending on the degree of risk involved in the research and the extent that the research is likely to be a benefit to the subject or relate to a subject's illness.
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The ethical conduct of research on humans requires more than a caring researcher and a legalistic adherence to federal regulations. It requires good planning and managing of issues accruing from the research relationship--communication, risk and perception of risk, and benefits--to all who have a stake in the relationship and outcome. In 1978 the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research identified ethical principles that should govern research on humans. Institutional review boards (IRBs) now exist in every organization that receives federal funding for human-subjects research. Researchers have an obligation to study the requirements of their IRB when they plan their research. Further, they must establish appropriate procedures for obtaining informed consent and assessing risk, risk perception, and ways to increase the benefits of research.
In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued an important report that addressed the difficult ethical issues arising in research involving subjects with mental disabilities. However, because of irreconcilable conflicts between the scientific community and rights-oriented advocacy groups, the federal government never issued the special regulations pertaining to these issues that had been envisioned by the National Commission. Because these important ethical issues have not yet been adequately addressed by policy-making bodies, protection of cognitively impaired subjects depends too heavily on the diverse ethical sensitivities of individual investigators and on ad hoc responses of particular institutional review boards. Researchers should support a credible and authoritative process for reexamining and resolving ethical issues relating to research with cognitively impaired subjects. This can be accomplished without leading to the stalemate that doomed the National Commission's proposals. The challenge is to forge a consensus on ethical guidelines and safeguards that will most reasonably accommodate the goals of protecting the dignity and well-being of research subjects while avoiding undue impediments to valuable scientific inquiry.
Biomedical research still does not have clear, written, agreed-upon underlying values (for a number of possible reasons that are discussed), and a variety of new pressures are making it necessary to formulate such principles. Toward that goal, this essay first traces the development of the underlying principles that have been formulated in the sphere of human subjects research, from the ancient Hippocratic injunction of do no harm to the three principles identified in 1979 by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research: respect for persons; beneficence; and justice. Using these principles as a pattern, the following "candidate principles" are proposed for biomedical research to stimulate discussion and the development of consensus among biomedical scientists: honesty of scientists (which encompasses the essential values of integrity, objectivity, verifiability, and truthfulness); respect for others (including respect for research subjects--both humans and other animals--colleagues, and the environment); scholarly competence (which is related to the processes of obtaining and passing on knowledge); and stewardship of resources (involving obligations to protect society from the problems intertwined with scientific advances). Guiding principles of this type must be articulated so they can be transmitted to upcoming scientists, who then can productively and responsibly help shape the future of the research enterprise.
The Food and Drug Administration (FDA) regulations on Institutional Review Boards (IRBs) and Informed Consent (IC) were published on January 27, 1981 and became operational on July 27, 1981. The historical development of these regulations began in August 1978 when the FDA proposed standards for IRBs. During the comment period, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted its report and recommendations on IRBs and informed consent. In its report, the National Commission recommended revision of the Department of Health and Human Services (DHHS) regulations and one uniform standard for IRBs. On August 14, 1979, the FDA withdrew the 1978 proposal and published a revised proposal that it had developed in conjunction with the DHHS in response to the recommendations made by the National Commission. Following consideration of the comments received on the 1979 proposal, the new regulations were published as final. I would like to discuss how these regulations relate to the FDA's mandate and regulatory responsibilities, to the work of IRBs, and to the protection of human subjects involved in the FDA-regulated research. I will also mention the FDA's internal organization to deal with IRB issues and, finally, what we may look forward to in the future.