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Agencies and Regulations for Human Subjects Research

Agencies

Department of Health and Human Services:

Regulations

The Common Rule

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Important Announcement: The U.S. Department of Health and Human Services (HHS) has announced proposed changes to the Federal Policy for the Protection of Human Subjects (aka the "Common Rule"). To find out more about the proposed changes and how they will affect the IRB submission and review process, please review the Notice of Proposed Rulemaking (NPRM) posted here by HSS and/or here by the Federal Register.

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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 Regulations

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.

FDA Regulations

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

Other Agencies

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

California Regulations

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.