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 unethi cal practices in radiation experiments involving human subjects that w ere sponsored by the US government between 1944 and 1974. The committe e's Final Report was released in October 1995. In addition to analyzin g the history of the ethics of medical research involving human subjec ts, the committee reviewed current federal policies and procedures for protection of human subjects. In this article, the committee's findin gs are discussed as they relate to the patient-physician relationship, the issue of trust, and the specific role of the physician-investigat or 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 l ikely to apply to ''healthy volunteers'' than to patient-subjects (ie, those with disease or illness). Today, consensus exists that duties t o 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 sponsor ship or funding (eg, federal, military, or private). Based on a findin g of serious deficiencies in the current system of protections for hum an subjects, the committee offers a number of recommendations, includi ng changes in institutional review boards, in the interpretation of et hics rules and policies; in oversight, accountability, and sanctions f or ethics violation: and in compensation for research injuries. More t han public policy changes, however, the committee recommends that the medical profession intensify its commitment to the ethics of research involving human subjects.