Common Rule


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. 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 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.

Background

The Common Rule is a 1991 rule of ethics 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 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.

Main elements

The main elements of the Common Rule include:
  • Requirements for assuring compliance by research institutions
  • Requirements for researchers' obtaining, waiving, and documenting informed consent
  • Requirements for Institutional Review Board 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 20 agencies and departments that have signed onto the Common Rule and their CFR numbers for those with published statutes.
  1. Department of Agriculture
  2. Department of Commerce, National Institute of Standards and Technology
  3. Department of Energy
  4. Department of Education
  5. Department of Defense
  6. Department of Health and Human Services
  7. Department of Homeland Security
  8. Department of Housing and Urban Development
  9. Department of Justice, National Institute of Justice
  10. Department of Labor
  11. Department of Transportation
  12. Department of Veterans Affairs, Office of Research Oversight, Office of Research and Development
  13. Agency for International Development
  14. Central Intelligence Agency
  15. Consumer Product Safety Commission
  16. Environmental Protection Agency, Research and Development
  17. National Aeronautics and Space Administration
  18. National Science Foundation
  19. Office of the Director of National Intelligence
  20. Social Security Administration