Informed Consent

Informed consent is at the heart of the ethical conduct of epidemiologic research. In 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created as a part of the National Research Act. This commission was developed in response to atrocities in the Tuskegee Syphilis Study and other research projects. Specific concerns focused on including individuals in research without their knowledge and, in the case of the Tuskegee study, provision of substandard medical care for the perceived benefit of the research project. The Belmont Report, developed by the Commission in 1978, laid the framework for the ethical conduct of research in the United States. Similar documents have been developed elsewhere, most notably the Declaration of Helsinki. All such documents ...