Agencies and Regulations for Human Subjects Research
Department of Health and Human Services:
The Common Rule
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). A final rule was published in the Federal Register (FR) on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018 and June 19, 2018.
The revised Common Rule is effective July 19, 2018; note that from July 19, 2018 through January 20, 2019 institutions are not permitted to implement the entirety of the revised Common Rule. This is explained in the transition provision (45 CFR 46.101(l), as amended June 19, 2018).
In 1991, the "Federal Policy for the Protection of Human Research Subjects," informally known as the "Common Rule" was issued by 15 federal departments and agencies. The Common Rule was based on the HHS 45 CFR part 46 subpart A, and includes identical language in the separate regulations of those departments and agencies. Technical amendments were made to the Common Rule in 2005. One additional agency (the Central Intelligence Agency) is required to follow the Common Rule by executive order, and one additional department (the Department of Homeland Security) chose to follow all HHS subparts. Other departments and agencies have adopted one or more of the other HHS subparts and some have their own additional human subject protection regulations.
For a complete listing of the agencies that follow the Common Rule please click here.
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 FDA regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA regulations are published in title 21 of the CFR. FDA's human subject protection regulations include:
21 CFR part 50, Protection of Human Subjects
21 CFR part 56, Institutional Review Boards
21 CFR part 312, Investigational New Drug Application
21 CFR part 812, Investigational Device Exemptions
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 and 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
Executive Order 12333, Central Intelligence Agency must comply with all subparts of 45 CFR part 46
45 CFR part 46, The Department of Homeland Security
The State of California has specific requirements for the protection of human subjects as provided in the Protection of Human Subjects in Medical Experimentation Act, CA HEALTH AND SAFETY CODE, SECTION 24170-24179.5.