Human subjects, third parties, and informed consent: a brief historical perspective of developments in the United States

The protection of human subjects in biomedical research has become a source of increasing concern over the past century. During the early days of human experimentation, the human subject was rarely if ever consulted about his or her participation in research because scientists and physicians acted in the traditional paternalistic role with respect to their subjects and patients. However, as options for both researchers and their subjects increased, more attention was focused on the rights and obligations of participants on both sides of the research relationship. Investigators became more aware of the costs and benefits associated with their research programs, and subjects became more curious about the nature of research and what could be reasonably expected from their participation. This paper reviews the evolution of the doctrine of informed consent in biomedical research and the development of rules and guidelines for the conduct of research in the United States, for the benefit of both researchers and their human subjects.