[American and European legislation on bioethics evaluation of clinical experimentation]

This paper describes the existing legislation for evaluating the bioethics of clinical trials (drug studies conducted on humans after completion of drug testing on animals). The legislation is presented in chronologic order; thus that of the United States is presented first, followed by a description of the European Union legislation, which includes a brief comment on Italian legislation. The rationale for informed consent and the specific requirements are addressed. Ethical committees are discussed in terms of their membership, responsibilities, and methods of revision. The paper concludes with a comparison between the USA and the European Union legislations.