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Federal Regulations, Ethical Codes, and International Compilation of Human Subject Research Protections

The Common Rule (Federal Policy for the Protection of Human Subjects) set forth the human subject protections requirements adopted by the following Federal agencies (Code of Federal Regulations). The University of Maryland, College Park Federal Wide Assurance assures that the University will apply The Common Rule to all human subject research regardless of the source of support.             

7 CFR Part 1c	Department of Agriculture
10 CFR Part 745	Department of Energy
14 CFR Part 1230	National Aeronautics and Space Administration
15 CFR Part 27	Department of Commerce
16 CFR Part 1028	Consumer Product Safety Commission
22 CFR Part 225	International Development Cooperation Agency, Agency for International Development
24 CFR Part 60	Department of Housing and Urban Development
28 CFR Part 46	Department of Justice
32 CFR Part 219	Department of Defense
34 CFR Part 97	Department of Education
38 CFR Part 16	Department of Veterans Affairs
40 CFR Part 26	Environmental Protection Agency
45 CFR Part 690	National Science Foundation
49 CFR Part 11	Department of Transportation

The Belmont Report was written by National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was created under the National Research Act (Pub. L. 93-348). One of the charges to the 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 which should be followed to assure that such research is conducted in accordance with those principles The Common Rule is based on the ethical principals described in The Belmont Report.

1. The Nuremberg Code is a set of standards that were proclaimed after the trial of Nazi doctors in 1947.
2. The Declaration of Helsinki is a statement of ethical principles regarding nontherapeutic research. The Declaration of Helsinki was first published by the World Medical Association in 1964 and has been revised. The 2004 statement is the most current version.
3. The International Compilation of Human Subject Research Protections is a listing of the laws, regulations, and guidelines that govern human subjects research in many countries around the world.

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This page last modified 10 March 2006
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