The Common Rule is a 1981 rule of ethics in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country Continental United States, primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., ...

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 The Declaration of Helsinki (DoH, fi, Helsingin julistus, sv, Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA ...

; it is encapsulated in the 1991 revision to the

U.S. Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...

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 1981 rule of ethics (revised in 2018) regarding biomedical and behavioral research involving human subjects in the

. The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the

, and are encapsulated in the 1991 revision to the

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.

Main elements

The main elements of the Common Rule include: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 * 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. #

Department of Agriculture An agriculture ministry (also called an) agriculture department, agriculture board, agriculture council, or agriculture agency, or ministry of rural development) is a ministry charged with agriculture. The ministry is often headed by a minister ...

(7 CFR Part 1c) #

Department of Commerce The United States Department of Commerce is an executive department of the U.S. federal government concerned with creating the conditions for economic growth and opportunity. Among its tasks are gathering economic and demographic data for busi ...

National Institute of Standards and Technology The National Institute of Standards and Technology (NIST) is an agency of the United States Department of Commerce whose mission is to promote American innovation and industrial competitiveness. NIST's activities are organized into physical s ...

(15 CFR Part 27) # Department of Energy (10 CFR Part 745) # Department of Education (34 CFR Part 97) #

Department of Defense Department of Defence or Department of Defense may refer to: Current departments of defence * Department of Defence (Australia) * Department of National Defence (Canada) * Department of Defence (Ireland) * Department of National Defense (Philipp ...

(32 CFR Part 219) #

Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is ...

(45 CFR Part 46) #

Department of Homeland Security The United States Department of Homeland Security (DHS) is the U.S. federal executive department responsible for public security, roughly comparable to the interior or home ministries of other countries. Its stated missions involve anti-ter ...

(6 CFR Part 46) #

Department of Housing and Urban Development The United States Department of Housing and Urban Development (HUD) is one of the executive departments of the U.S. federal government. It administers federal housing and urban development laws. It is headed by the Secretary of Housing and Ur ...

(24 CFR Part 60) # Department of Justice,

National Institute of Justice The National Institute of Justice (NIJ) is the research, development and evaluation agency of the United States Department of Justice. NIJ, along with the Bureau of Justice Statistics (BJS), Bureau of Justice Assistance (BJA), Office of Juvenil ...

(28 CFR Part 46) # Department of Labor (29 CFR Part 21) # Department of Transportation (49 CFR Part 11) # Department of Veterans Affairs,

Office of Research Oversight An office is a space where an organization's employees perform administrative work in order to support and realize objects and goals of the organization. The word "office" may also denote a position within an organization with specific du ...

Office of Research and Development An office is a space where an organization's employees perform administrative work in order to support and realize objects and goals of the organization. The word "office" may also denote a position within an organization with specific du ...

(38 CFR Part 16) #

Agency for International Development The United States Agency for International Development (USAID) is an independent agency of the U.S. federal government that is primarily responsible for administering civilian foreign aid and development assistance. With a budget of over $27 b ...

(USAID) (22 CFR Part 225) #

Central Intelligence Agency The Central Intelligence Agency (CIA ), known informally as the Agency and historically as the Company, is a civilian foreign intelligence service of the federal government of the United States, officially tasked with gathering, processing, ...

Consumer Product Safety Commission The United States Consumer Product Safety Commission (USCPSC, CPSC, or commission) is an independent agency of the United States government. The CPSC seeks to promote the safety of consumer products by addressing “unreasonable risks” of inj ...

(16 CFR Part 1028) #

Environmental Protection Agency A biophysical environment is a biotic and abiotic surrounding of an organism or population, and consequently includes the factors that have an influence in their survival, development, and evolution. A biophysical environment can vary in scale ...

, Research and Development (40 CFR Part 26) #

National Aeronautics and Space Administration The National Aeronautics and Space Administration (NASA ) is an independent agency of the US federal government responsible for the civil space program, aeronautics research, and space research. NASA was established in 1958, succeeding ...

(14 CFR Part 1230) #

National Science Foundation The National Science Foundation (NSF) is an independent agency of the United States government that supports fundamental research and education in all the non-medical fields of science and engineering. Its medical counterpart is the National ...

(45 CFR Part 690) # Office of the Director of National Intelligence #

Social Security Administration The United States Social Security Administration (SSA) is an independent agency of the U.S. federal government that administers Social Security, a social insurance program consisting of retirement, disability and survivor benefits. To qualify f ...

(20 CFR 431)

References

External links

government page on Common Rule
United States Department of Health and Human Services Clinical research ethics {{Research participant rights