The Common Rule is a 1991 rule of ethics in the

United States The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 ...

regarding biomedical and behavioral research involving human subjects. A significant revision became effective July 2018. It governed

Institutional Review Board An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed ...

s for oversight of human research and followed the 1975 revision of the

Declaration of Helsinki The Declaration of Helsinki (DoH, ) 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 widely regarded as the cornerstone document o ...

; 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) regarding biomedical and behavioral research involving human subjects in the

. The regulations governing

s for oversight of human research followed the 1975 revision of the

, 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.

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 f ...

(7 CFR Part 1c) #

Department of Commerce The United States Department of Commerce (DOC) is an United States federal executive departments, executive department of the Federal government of the United States, U.S. federal government. It is responsible for gathering data for business ...

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 Outline of p ...

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

Department of Education An education ministry is a national or subnational government agency politically responsible for education. Various other names are commonly used to identify such agencies, such as Ministry of Education, Department of Education, and Ministry of Pub ...

(34 CFR Part 97) #

Department of Defense The United States Department of Defense (DoD, USDOD, or DOD) is an executive department of the U.S. federal government charged with coordinating and supervising the six U.S. armed services: the Army, Navy, Marines, Air Force, Space Force, ...

(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 US federal government created to protect the health of the US people 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, home, or public security ministries in other countries. Its missions invol ...

(6 CFR Part 46) # Department of Housing and Urban Development (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 (DOJ). NIJ, along with the Bureau of Justice Statistics (BJS), Bureau of Justice Assistance (BJA), Offic ...

(28 CFR Part 46) #

Department of Labor A ministry of labour (''British English, UK''), or labor (''American English, US''), also known as a department of labour, or labor, is a government department responsible for setting labour standards, labour dispute mechanisms, employment, workfor ...

(29 CFR Part 21) # Department of Transportation (49 CFR Part 11) # Department of Veterans Affairs, Office of Research Oversight, Office of Research and Development (38 CFR Part 16) # Agency for International Development (USAID) (22 CFR Part 225) #

Central Intelligence Agency The Central Intelligence Agency (CIA; ) is a civilian foreign intelligence service of the federal government of the United States tasked with advancing national security through collecting and analyzing intelligence from around the world and ...

# Consumer Product Safety Commission (16 CFR Part 1028) # Environmental Protection Agency, 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 United States's civil space program, aeronautics research and space research. Established in 1958, it su ...

(14 CFR Part 1230) #

National Science Foundation The U.S. National Science Foundation (NSF) is an Independent agencies of the United States government#Examples of independent agencies, independent agency of the Federal government of the United States, United States federal government that su ...

(45 CFR Part 690) #

Office of the Director of National Intelligence The director of national intelligence (DNI) is a cabinet-level United States government intelligence and security official. The position is required by the Intelligence Reform and Terrorism Prevention Act of 2004 to serve as executive head o ...

Social Security Administration The United States Social Security Administration (SSA) is an Independent agencies of the United States government, independent agency of the Federal government of the United States, U.S. federal government that administers Social Security (United ...

(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