RegulationsAll regulations issued by federal agencies under the
statutory authority established by Congress are published in the
Code of Federal Regulations (CFR). Basic regulations governing
the protection of human subjects in research supported or
conducted by the Department of Health and Human Services (HHS,
then the Department of Health, Education and Welfare) were first
published at 45 CFR part 46 in 1974. In the United States, a
series of highly publicized abuses in research led to the
enactment of the 1974 National Research Act (Public Law 93-348),
which created the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research. One of the
charges to the National Commission was to identify the basic
ethical principles that should underlie the conduct of
biomedical and behavioral research involving human subjects and
to develop guidelines to assure that such research is conducted
in accordance with those principles. In 1978, the Commission
published “Ethical Principles an