Research ethics and the medical profession. Report of the Advisory Committee on Human Radiation Experiments.

The Advisory Committee on Human Radiation Experiments was convened by President Clinton in January 1994 in response to allegations of unethical practices in radiation experiments involving human subjects that were sponsored by the US government between 1944 and 1974. The committee's Final Report was released in October 1995. In addition to analyzing the history of the ethics of medical research involving human subjects, the committee reviewed current federal policies and procedures for protection of human subjects. In this article, the committee's findings are discussed as they relate to the patient-physician relationship, the issue of trust, and the specific role of the physician-investigator in all types of human experimentation. The committee found evidence of discussion of the conduct of human research at the highest levels of the government and within the medical profession, particularly with regard to risk, during the 1940s and 1950s. However, in both federal policy and professional practice, requirements for consent were more likely to apply to "healthy volunteers" than to patient-subjects (ie, those with disease or illness). Today, consensus exists that duties to obtain informed consent apply to all human subjects, whether healthy or sick, regardless of the risk or potential for medical benefit from participation in the research and regardless of the nature of sponsorship or funding (eg, federal, military, or private). Based on a finding of serious deficiencies in the current system of protections for human subjects, the committee offers a number of recommendations, including changes in institutional review boards; in the interpretation of ethics rules and policies; in oversight, accountability, and sanctions for ethics violations; and in compensation for research injuries. More than public policy changes, however, the committee recommends that the medical profession intensify its commitment to the ethics of research involving human subjects.