Common Rule

The section of the Code of Federal Regulations (CFR) dealing with the HHS' codification of the Common Rule

The Common Rule is a federal policy governing the protection of human research subjects as uniformly codified in separate regulations of numerous United States departments and agencies. Originally published in 1991, the Common Rule later was substantially revised and the revised Common Rule published in the Federal Register in 2017 and then further amended and finalized in 2018; it outlines provisions for Institutional Review Boards (IRBs), informed consent, and other aspects related to research involving human subjects.

Initially fifteen Federal departments adopted the regulations in 1991, including the Department of Health and Human Services (HHS), the Department of Agriculture (USDA), the Department of Energy (DOE), and the Department of Defense (DOD). Four additional departments or agencies of the United States followed the pre-2018 Common Rule because of executive order or statutory mandate. All of these departments or agencies are following, or intend to follow, the revised (2018) Common Rule. One additional department that was not a signatory of the pre-2018 Common Rule, the Department of Labor, has become a signatory to the revised Common Rule. As of July 2021, there were twenty Common Rule Departments or Agencies.

The Federal Policy for the Protection of Human Subjects, or Common Rule, is codified in the Code of Federal Regulations (CFR), with each of the diverse departments/agencies utilizing identical language and section numbers in its particular chapter of the CFR. For the HHS regulations, the Common Rule constitutes subpart A, 45 CFR, part 46. For the DOE, the Common Rule is in 10 CFR, Part 745, and for the DOD in 32 CFR Part 219. Below is listed each department and agency that has adopted the Common Rule, along with the respective section of the CFR.

The development of the Common Rule came in response to growing public awareness of mistreatment of people as subjects in human research, such as the abuses in the Tuskegee Syphilis Study by the U.S. Public Health Service, and came on the foundation of various efforts, such as the National Research Act of 1974 and the Belmont Report, to provide guidance so that human subject research follows ethical standards. The adoption of the Common Rule represents a milestone in assuring that government departments and agencies have in place regulations to protect human subjects.

Overview

According to the published regulations, the Common Rule policy "applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency" and "includes research conducted by Federal civilian employees or military personnel" (Subpart A of 45 CFR Part 46, 46.101). It is further noted that "department or agency heads retain final judgement as to whether a particular activity is covered by this policy and this judgement shall be exercised consistent with the ethical principles of the Belmont Report."

Among the areas covered in the Common Rule are:

• Definitions (such as the meaning of "human subject," "identifiable private information," "IRB," "minimal risk," and "research")
• IRB membership, functions, operations, review of research, criteria for approval of research, and record maintenance
• General requirements for informed consent
• Expedited review procedures
• Exempt research (such as taste and food quality evaluation and consumer acceptance studies)

For example, "research" is defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." It is further noted that "the following activities are deemed not to be research: (1) Scholarly and journalistic activities ... (2) Public health surveillance activities ... (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes ... (4) authorized operation activities ... in support of intelligence, homeland security, defense, or other national security measures."

"Human subject" is defined as "a living individual about whom an investigator ... conducting research: (1) obtains information or biospecimens through intervention or interaction with the individuals, and uses, studies, or analyzes the information or biospecimens; (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

Great detail is provided for what constitutes exempt research, and thus is exempt for IRB review. The following is an excerpt on one of the categories of human subject research exempt from this policy:

(2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 46.111(a)(7).

2018 revisions

The original Common Rule was substantially revised and the revised regulations were published in 2017 and further amended in 2018. The earlier Common Rule is sometimes referenced as the "pre-2018 requirements" and the current version as the "revised Common Rule," "2018 requirements" or "2018 Rule" (Hautala-Bateman and White 2019).

Among key revisions were the following (Hautala-Bateman and White 2019):

• Modification of the definitions of "human subject," "research," and "identifiable private information"
• Addition of a definition of "clinical trial"
• Updating of a definition of "vulnerable (to Coercion or Undue Influence)" to no longer include reference to pregnant woman, handicapped, or physically disabled individuals as examples of populations that are potentially vulnerable to coercion or undue influence
• Use of the term "individuals with impaired decision-making ability" to replace the term "mentally disabled persons"
• Revision of exemption categories for minimal risk human subjects research
• Removal of requirement to conduct continuing review for certain studies (such as particular minimal risk studies and studies that are complete in terms of study interventions and are merely analyzing study data or conducting only observation follow-up as part of standard clinical care)
• Addition of a new requirement for institutions based in the Untied States involved in cooperative research to use a single IRB for the research that takes place in the United States (with some exemptions)
• Establishment of new requirements regarding informed consent (in other words, the information given to prospective research subjects)

History

The promulgation of the Common Rule came on the foundation of the National Research Act of 1974, which set up the modern Institutional Review Board (IRB) system. It also relies heavily on the Belmont Report, which is also a product of the National Research Act.

The National Research Act (Public Law 93-348) was signed into law on July 12, 1974, by United States President Richard M. Nixon. The United States Congress had passed this law in response to concerns regarding the exploiting and harming of human subjects in medical, biomedical, and social science research. The Act created the National Commission for Protection of Human Subjects of Biomedical and Behavior Research, which had the goal of identifying ethical guidelines for human subject research and would issue the Belmont Report. The Act also directed that human subject research be reviewed and approved by IRBs.

Following the direction of the National Research Act, the main IRB regulations were established by diverse government agencies. The United States Department of Health and Human Services (HHS) initially promulgated their regulations in 1981. (HHS, then the Department of Health, Education, and Welfare or HEW, had actually published various basic regulations regarding protecting human research subjects back in 1974. The Department of Health, Education, and Welfare became the Department of Health and Human Services on May 4, 1980.) In 1991, fifteen federal departments or agencies (this includes HHS) adopted identical rules, including the Departments of Agriculture, Energy, Commerce, Justice, Housing and Urban Development, Defense, and Education. These departments or agencies were official signatories and codified the rule in each of their chapters of the Code of Federal Regulations (CFR). Because these regulations are common to many federal agencies, the regulations were referred to as the Common Rule. Four additional agencies or departments (Central Intelligence Agency, Social Security Administration, Department of Homeland Security, Office of the Director of National Intelligence) adopted the regulations because of executive order or statutory mandate.

The Common Rule was subsequently revised, with final revisions to the Common Rule published in the Federal Register on January 19, 2017. The Common Rule was further amended on January 22, 2018 and finalized on June 19, 2018. The date for which organizations were to begin complying with the revised Common Rule was January 21, 2019. This revised Common Rule began to be referred to as "revised Common Rule," "2018 requirements" or "2018 Rule," while the earlier version as the "pre-2018 requirements" (Hautala-Bateman and White 2019).

For the revised Common Rule, all the original signatories became official signatories with the exception of the Department of Justice, which intends to become an official signatory (HHS 2021a). There was also one new signatory, the Department of Labor, that had not been a signatory to the original Common Rule. In addition, two agencies that had followed the pre-2018 Common rule because of statutory mandate or executive order became official signatories of the revised Common Rule.

For the Department of Health and Human Services, the Common Rule refers to subpart A of 45 CFR, part 46 of the HSS regulations. There are five subparts, the others dealing with protections for pregnant woman, human fetus, neonates (subpart B), prisoners (subpart C), children (subpart D), and requirements for IRB registration (subpart E). Each agency that has signed onto the Common Rule has identical section numbers and language in its own chapter of the Code of Federal Regulations, CFR, to those of the HHS codification at subpart A of 45 CFR, part 46 (HHS 2021).

Departments and Agencies that are Signatories to, or follow, the Common Rule

The following information was provided by the United States Department of Health and Human Services (HHS 2021a).

Dept. or Agency	CFR Citation (2018)	Status
Dept. of Homeland Security	6 CFR Part 46	Followed pre-2018 Common Rule by stature; Signatory to revised Common Rule
Dept. of Agriculture	7 CFR Part 1c	Signatory of both pre-2018 Common Rule and revised Common Rule
Dept. of Energy	10 CFR Part 745	Signatory of both pre-2018 Common Rule and revised Common Rule
NASA	14 CFR Part 1230	Signatory of both pre-2018 Common Rule and revised Common Rule
Dept. of Commerce	15 CFR Part 27	Signatory of both pre-2018 Common Rule and revised Common Rule
Social Security Administration	20 CFR Part 431	Followed pre-2018 Common Rule after split from HHS in 1995; Signatory to revised Common Rule
Agency for International Development	22 CFR Part 225	Signatory of pre-2018 Common Rule and intends to become signatory of revised Common Rule
Dept. of Housing and Urban Development	24 CFR Part 60	Signatory of both pre-2018 Common Rule and revised Common Rule
Dept. of Justice	28 CFR Part 46	Signatory of pre-2018 Common Rule; intends to become official signatory of revised Common Rule
Dept. of Labor	29 CFR Part 21	Was not a signatory of pre-2018 Common Rule; is a signatory of revised Common Rule
Dept. of Defense	32 CFR Part 219	Signatory of both pre-2018 Common Rule and revised Common Rule
Dept. of Education	34 CFR Part 97	Signatory of both pre-2018 Common Rule and revised Common Rule
Dept. of Veterans Affairs	38 CFR Part 16	Signatory of both pre-2018 Common Rule and revised Common Rule
Environmental Protection Agency	40 CFR Part 26	Signatory of both pre-2018 Common Rule and revised Common Rule
Dept. of Health and Human Services	45 CFR Part 46	Signatory of both pre-2018 Common Rule and revised Common Rule
National Science Foundation	45 CFR Part 690	Signatory of both pre-2018 Common Rule and revised Common Rule
Dept. of Transportation	49 CFR Part 11	Signatory of both pre-2018 Common Rule and revised Common Rule
Office of Director of National Intelligence	None	Followed pre-2018 Common Rule and follows revised Common Rule because of Executive Order
Central Intelligence Agency	None	Followed pre-2018 Common Rule and follows revised Common Rule because of Executive Order
Consumer Product Safety Commission	16 CFR Part 1028	Signatory of pre-2018 Common Rule and intends to become signatory of revised Common Rule

Note that the U.S. Food and Drug Administration (FDA), while an agency of the Department of Health and Human Services (HSS), is not a Common Rule agency, but harmonizes with the Common Rule when permitted by law (HHS 2021a).

See also

• Belmont Report
• Declaration of Helsinki
• Human subject research
• Informed consent
• Nuremberg Code
• Tuskegee Syphilis Study

References

ISBN links support NWE through referral fees

• Amdur, Robert J., and Elizabeth A. Bankert. 2022. Institutional Review Book: Member Handbook, 4th Edition. Burlington, MA: Jones & Bardett Learning.
• Hautala-Bateman, C., and L. White. May 14, 2019. Changes to the Common Rule. PowerPoint Presentation to the Central Department of Energy Institutional Review Board Meeting of May 14, 2019.
• National Commission for the Protection of Human Subjects of Biomedical and Behavior Research. April 18, 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Retrieved July 23, 2021.
• US Department of Health and Human Services (HHS). 2021a. Federal Policy for the Protection of Human Subjects ('Common Rule'). Retrieved July 23, 2021.
• US Department of Health and Human Services (HHS), Office of the Assistant Secretary of Health, Office for Human Research Protections (HHS). 2021b. Subpart A of 45 CFR Part 46: Basic HHS Policy for Protection of Human Subjects. PDF version. Official HTML version Retrieved July 23, 2021.

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