The social control of human biomedical research: an overview and review of the literature.

Social control mechanisms have become an important element of human medical research in the United States. At first largely intraprofessional, controls over human experimentation have moved increasingly in the direction of externally developed, bureaucratically administered, and formally sanctioned rules. This paper examines intra- and extraprofessional methods of control over biomedical science and reviews available research assessing their effectiveness in promoting researcher adherence to high ethical standards concerning the use of human subjects. Research suggests that intraprofessional controls (including medical training, peer influence, ethical codes, and disciplinary boards), are, on their own, inadequate to ensure investigator ethicality. However, studies examining external controls over biomedical research (government regulations, institutional review boards, judicial and state law), also suggest that extraprofessional regulations are often ineffective. Further study of both forms of scientific social control is needed, as well as research examining their interactive effects on investigators' ethical attitudes and practices.