Reforming the Regulations Governing Research with Human Subjects

The federal policy regulating research with human subjects, known as the Common Rule, has not been modified since its publication in 1991. A working group convened by the OMB has drafted a proposal to revise the Common Rule and seeks public comment. In the wake of the scandal surrounding the Tuskege...

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Bibliographic Details
Published inThe New England journal of medicine Vol. 365; no. 12; pp. 1145 - 1150
Main Authors Emanuel, Ezekiel J, Menikoff, Jerry
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 22.09.2011
Subjects
Ethics Committees, Research
Federal policy
Government Regulation
Human Experimentation - legislation & jurisprudence
Human subjects
Humans
Researchers
Review boards
Revisions
United States
Working groups
United States
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Summary:The federal policy regulating research with human subjects, known as the Common Rule, has not been modified since its publication in 1991. A working group convened by the OMB has drafted a proposal to revise the Common Rule and seeks public comment. 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 . . .
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ISSN:0028-4793
1533-4406
1533-4406
DOI:10.1056/NEJMsb1106942