Content area
Abstract
According to these regulations, the value of research to society does not justify violating the rights of individual subjects. Federal regulations5 establish the priority of individual subjects implicity, by defining in detail their right to be informed about a study in which they are asked to participate, to refuse participation, to be informed of findings that may modify their decision as the trial proceeds, and to withdraw without penalty. [...]in this country ethical standards are not to be relaxed because the study is important. Institutional review boards (IRBs) are to review clinical research studies to see that they conform to ethical standards; their approval is necessary for obtaining federal funding, but it does not generally substitute for informed consent. According to this view, if informed consent is not an accepted concept in a society or if a community leader customarily speaks for the members of the community, we should not insist that subjects give informed consent.