The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.
The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below. The HHS regulations, 45 CFR part 46,1 include four subparts: subpart A, also known as the Federal Policy or the “Common Rule;” Subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and Subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, Subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. The head of that
1To view the full Code of Federal Regulations, visit the U.S. Department of Health and Human Services website: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research.
The list below displays the agencies and departments that have signed onto the Common Rule and their CFR numbers. Hyperlinks are to areas of a department or agency website that have been suggested to HHS as entry points for those interested in human subject protection activities of the department or agency.
|7 CFR Part 1c||Department of Agriculture|
|10 CFR Part 745||Department of Energy|
|14 CFR Part 1230||National Aeronautics and Space Administration|
|15 CFR Part 27||Department of Commerce
National Institute of Standards and Technology
|16 CFR Part 1028||Consumer Product Safety Commission|
|22 CFR Part 225||Agency for International Development (USAID)|
|24 CFR Part 60||Department of Housing and Urban Development|
|28 CFR Part 46||Department of Justice
National Institute of Justice
|32 CFR Part 219||Department of Defense|
|34 CFR Part 97||Department of Education|
|38 CFR Part 16||Department of Veterans Affairs
Office of Research Oversight
Office of Research and Development
|40 CFR Part 26||Environmental Protection Agency
Research and Development
|45 CFR Part 46||Department of Health and Human Services|
|45 CFR Part 690||National Science Foundation|
|49 CFR Part 11||Department of Transportation|
Although they have not issued the Common Rule in regulations, three other departments and agencies comply with all subparts of 45 CFR part 46. These include:
• The Central Intelligence Agency, by executive order, must comply with all subparts of 45 CFR Part 46. (Executive Order 12333, paragraph 2.10)
• The Department of Homeland Security, created after issuance of the Common Rule, has chosen to apply all subparts of 45 CFR part 46 to its human research activities. (6 U.S.C. section 112)
• The Social Security Administration was separated from HHS in 1994 and, absent action by the Administrator, must apply all regulations that applied to SSA before the separation. (42 U.S.C. section 901)
Several non-HHS federal departments and agencies have additional regulations in place for research involving special populations or for human subjects research in general. The federal department/agency that conducts or supports research retains final authority for determining whether an institution has complied with its regulations for the protection of human subjects. If HHS receives an allegation or indication of noncompliance related to human subject research that is conducted or supported solely by a Common Rule department/agency other than HHS, HHS will refer the matter to that department/agency for review and action as appropriate.
Investigators are encouraged to review the regulations of the funding agency to determine whether additional regulations apply. Also, many agencies have not adopted Subparts B, C, or D and grantees of those agencies are not necessarily bound by them. Grantees should consult their funding agency for guidance.
SOURCE: Federal Policy for the Protection of Human Subjects (“Common Rule”). Available: http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html [December 2013].