Tu banner alternativo

Common Rule

In today's world, Common Rule has gained great importance in various areas of our lives. From politics to technology, culture and society, Common Rule has become a topic of constant conversation and debate. Opinions on Common Rule vary widely, demonstrating the complexity and importance it has today. This article will seek to explore different aspects of Common Rule, delving into its impact and relevance in today's society. From its origins to its influence on everyday life, Common Rule has generated great interest and it is crucial to understand its reach and impact on the contemporary world.

Tu banner alternativo
This article is about US rule of ethics. For the Australian industry award, see common rule awards. Not to be confused with common law.

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.

Background

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]

Main elements

The main elements of the Common Rule include:[4]

  • Requirements for assuring compliance by research institutions
  • Requirements for researchers' obtaining, waiving, 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 20 agencies and departments that have signed onto the Common Rule and their CFR numbers for those with published statutes.

  1. Department of Agriculture (7 CFR Part 1c)
  2. Department of Commerce, National Institute of Standards and Technology (15 CFR Part 27)
  3. Department of Energy (10 CFR Part 745)
  4. Department of Education (34 CFR Part 97)
  5. Department of Defense (32 CFR Part 219)
  6. Department of Health and Human Services (45 CFR Part 46)
  7. Department of Homeland Security (6 CFR Part 46)
  8. Department of Housing and Urban Development (24 CFR Part 60)
  9. Department of Justice, National Institute of Justice (28 CFR Part 46)
  10. Department of Labor (29 CFR Part 21)
  11. Department of Transportation (49 CFR Part 11)
  12. Department of Veterans Affairs, Office of Research Oversight, Office of Research and Development (38 CFR Part 16)
  13. Agency for International Development (USAID) (22 CFR Part 225)
  14. Central Intelligence Agency
  15. Consumer Product Safety Commission (16 CFR Part 1028)
  16. Environmental Protection Agency, Research and Development (40 CFR Part 26)
  17. National Aeronautics and Space Administration (14 CFR Part 1230)
  18. National Science Foundation (45 CFR Part 690)
  19. Office of the Director of National Intelligence
  20. Social Security Administration (20 CFR 431)

References

  1. ^ "Regulations". 16 February 2016.
  2. ^ "Federal Policy for the Protection of Human Subjects ('Common Rule')". United States Department of Health and Human Services. Retrieved July 10, 2024.
  3. ^ U.S. Department of Health and Human Services. "Code of Federal Regulations - Title 45 Public Welfare CFR 46". Retrieved 2014-07-25.
  4. ^ 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
Wikious
Boobota
Sagapedia