Reforming the regulations governing research with human subjects.

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].) Since 1991, there has been almost no change to the Common Rule. Yet research with humans has substantially increased in volume, with more international and multisite studies, more healthservices research, and more research with biospecimens.1,2 Decades of experience have revealed a great deal about the functioning — and limitations — of existing regulations, and have prompted critical evaluations by the Institute of Medicine, the Government Accountability Office, and many scholars.3,4 Two themes emerge from these critiques. First, there are complaints that the regulations impose a variety of burdensome bureaucratic procedures that seem to do little to protect research participants, yet consume substantial resources. These impediments are claimed to be particularly vexing for researchers conducting studies that pose few physical or psychological risks. More important, critics have noted that current regulations could be doing a significantly better job in protecting research subjects.