The Common Rule is the 1981 ethical rule in the United States on biomedical and behavioral research involving human subjects. It regulates the Institutional Review Board for the supervision of human research and follows the 1975 revision of the Helsinki Declaration; it is packaged in a 1991 revision to the Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A. General Rules are the basic ethical standards in which any government- funded research in the US is held; virtually all US academic institutions detain their researchers for this rights statement regardless of funding.
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The Common Rule is the 1981 ethical rule of biomedical and behavioral research involving human subjects in the United States. The regulations governing the Institutional Review Board for the supervision of human research follow the 1975 revision of the Helsinki Declaration, and summarized in a 1991 revision to the US Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A. General rules are the basic ethical standards by which government-funded research in the US is conducted; virtually all academic institutions are holding back their researchers for these rights claims regardless of funding.
Maps Common Rule
Primary element
The main elements of the Common Rule include:
- Requirements to ensure compliance by the research institute
- Requirements for researchers to obtain and document informed consent
- Requirements for membership, functions, operations, review, and research of Institutional Review Board (IRB) listing.
General Rules include additional protection for certain vulnerable research subjects :
- Subdivision B provides additional protection for pregnant women, in-vitro fertilization, and fetuses
- Sub section C contains additional protection for prisoners
- Part D does the same for children.
Signer
The list below shows the 16 agencies and departments that have signed the General Regulations and their CFR figures.
- Department of Agriculture (7 CFR Part 1c)
- Department of Energy (10 CFR Part 745)
- National Aviation and Space Agency (14 CFR Part 1230)
- Department of Commerce, National Institute of Standards and Technology (15 CFR Part 27)
- Consumer Product Safety Commission (16 CFR Section 1028)
- International Development Agency (USAID) (22 CFR Part 225)
- Department of Housing and Urban Development (24 CFR Part 60)
- Department of Justice, National Justice Institute (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 Supervision, 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
External links
page of government on the Common Rule
Source of the article : Wikipedia
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