Regulations Governing Research Involving Human Participants
The Common Rule
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. The HHS regulations, 45 CFR part 46, 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 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.
Health and Human Subjects, Office of Human Research Protections, Code of Federal Regulations Title 45 Part 46 Protection for Human Subjects (45 CFR 46)
HHS human subject protection regulations at 45 CFR part 46 were first issued in 1974. In 1978, the National Commission or the Protection of Human Subjects of Biomedical and Behavioral Research published “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as the Belmont Report, named after the Belmont Conference Center where the Commission met when drafting the report. The Belmont Report identifies three fundamental ethical principles for all human subjects research: respect for persons, beneficence, and justice.
The current version of 45 CFR 46 includes five subparts
- Subpart A is the basic set of protections for all human subjects of research conducted or supported by HHS, and was revised in 1981 and 1991, with technical amendments made in 2005.
- Subpart B, issued in1975, and most recently revised in 2001, provides additional protections for pregnant women, human fetuses, and neonates involved in research.
- Subpart C, issued in 1978, provides additional protections pertaining to biomedical and behavioral research involving prisoners as subjects.
- Subpart D, issued in 1983, provides additional protections for children involved as subjects in research.
- Subpart E, issued in 2009, requires registration of institutional review boards (IRBs) which conduct review of human research studies conducted or supported by HHS.