Research with Human Subjects

Reforming the Regulations Governing Research with Human Subjects

NEJM | July 25, 2011 | Topics: Comparative Effectiveness, Quality of Care

Ezekiel J. Emanuel, M.D., Ph.D., and Jerry Menikoff, M.D., J.D.

In the wake of the scandal surrounding the Tuskegee syphilis study, Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission investigated and made recommendations regarding basic ethical principles guiding research with human beings and the special principles relating to research with fetuses, prisoners, and children. In 1981, on the basis of the National Commission’s recommendations, the Department of Health and Human Services (DHHS) revised and expanded its regulations regarding the protection of human subjects, which were entered into the Code of Federal Regulations (title 45, part 46). In 1991, subpart A of those regulations, delineating the general rules for informed consent and for the operation of institutional review boards (IRBs), was extended to 14 other federal departments, thus creating what came to be called the Common Rule. (Similar, but not identical regulations, title 21, parts 50 and 56, govern research with human beings regulated by the Food and Drug Administration [FDA].)/.../