Common Rule
The Common Rule is a rule of ethics regarding biomedical and behavioral research involving human subjects in the United States. These regulations governing Institutional Review Boards for oversight of human research came into effect in 1981 following the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A ("The Common Rule") is the baseline standard of ethics by which any government-funded research in the US is held, and nearly all academic institutions hold their researchers to these statements of rights regardless of funding.[1]
Main elements
The main elements of the Common Rule include:[2]
- Requirements for assuring compliance by research institutions
- Requirements for researchers' obtaining and documenting informed consent
- Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.
The Common Rule includes additional protections for certain vulnerable research subjects:
- Subpart B provides additional protections for pregnant women, in vitro fertilization, and fetuses
- Subpart C contains additional protections for prisoners
- Subpart D does the same for children.
Signatories
The list below displays the 16 agencies and departments that have signed onto the Common Rule and their CFR numbers.
- Department of Agriculture (7 CFR Part 1c)
- Department of Energy (10 CFR Part 745)
- National Aeronautics and Space Administration (14 CFR Part 1230)
- Department of Commerce, National Institute of Standards and Technology (15 CFR Part 27)
- Consumer Product Safety Commission (16 CFR Part 1028)
- Agency for International Development (USAID) (22 CFR Part 225)
- Department of Housing and Urban Development (24 CFR Part 60)
- Department of Justice, National Institute of Justice (28 CFR Part 46)
- Department of Defense (32 CFR Part 219)
- Department of Education (34 CFR Part 97)
- Department of Veterans Affairs, Office of Research Oversight, Office of Research and Development (38 CFR Part 16)
- Environmental Protection Agency, Research and Development (40 CFR Part 26)
- Department of Health and Human Services (45 CFR Part 46)
- National Science Foundation (45 CFR Part 690)
- Department of Transportation (49 CFR Part 11)
- Social Security Administration (20 CFR 431)
References
- ↑ U.S. Department of Health and Human Services. "Code of Federal Regulations - Title 45 Public Welfare CFR 46". Retrieved 2014-07-25.
- ↑ Korenman, S.G., Teaching the Responsible conduct of Research in humans (RCRH) Common Rule, Office of Research Integrity, US Department of Health and Human Services
External links
government page on Common Rule