The Common Rule is a 1991 rule of ethics in the United States regarding biomedical and behavioral research involving human subjects. A significant revision became effective July 2018.[1] It governed Institutional Review Boards for oversight of human research and followed the 1975 revision of the Declaration of Helsinki; it is 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; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding.
The Common Rule is a 1991 rule of ethics (revised in 2018)[2] regarding biomedical and behavioral research involving human subjects in the United States. The regulations governing Institutional Review Boards for oversight of human research followed 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; nearly all academic institutions hold their researchers to these statements of rights regardless of funding.[3]
The main elements of the Common Rule include:[4]
The Common Rule includes additional protections for certain vulnerable research subjects:
The list below displays the 20 agencies and departments that have signed onto the Common Rule and their CFR numbers for those with published statutes.
|
Research participant rights
| |
|---|---|
| Rights |
|
| Human subject research |
|
| Ethical systems |
|
| Guidelines for human subject research |
|
| Monitoring in clinical trials |
|
