Abstract

It is universally accepted that informed consent to participate in medical research should be given by subjects. People have the fundamental human right to freely choose, without coercion or withholding of information necessary to make a reasonable choice, whether they will undergo any risks associated with a research project. United States researchers have known for some time that they have the duty to inform potential subjects of the nature of proposed research and the risks and possible benefits, and to seek consent. Investigators also have the duty to design the research so that it will be scientifically valid while minimizing foreseeable and avoidable harms