Common Rule

Common Rule is a rule of ethics in the United States that provides protection for human subjects in biomedical and behavioral research. It was first published in 1991 and has been revised several times, most recently in 2018. The Common Rule is also known as the Federal Policy for the Protection of Human Subjects.

Overview

The Common Rule applies to all federal agencies that conduct, support, or otherwise regulate research involving human subjects. It sets forth requirements for ensuring that such research is conducted ethically and with respect for the rights and welfare of the participants. The rule is named "Common" because it is common to 20 federal agencies, including the Department of Health and Human Services (HHS), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA).

Key Provisions

The Common Rule includes several key provisions designed to protect human subjects in research. These include requirements for informed consent, review of research by an Institutional Review Board (IRB), and additional protections for vulnerable populations such as children, prisoners, and pregnant women.

Informed Consent

Under the Common Rule, researchers must obtain and document the informed consent of each participant. This means that participants must be given sufficient information about the research, including its purpose, duration, procedures, risks, benefits, and alternatives, and must be given the opportunity to ask questions and to withdraw from the research at any time.

Institutional Review Board

The Common Rule requires that all research involving human subjects be reviewed and approved by an IRB. The IRB is responsible for ensuring that the research is ethical and that the rights and welfare of the participants are protected.

Protections for Vulnerable Populations

The Common Rule includes additional protections for certain vulnerable populations. For example, research involving children must meet additional criteria, and research involving prisoners must be reviewed by a special subcommittee of the IRB.

Revisions

The Common Rule has been revised several times since it was first published. The most recent revision, known as the "Final Rule," was published in 2018 and includes several significant changes, such as a new provision allowing for broad consent for the use of identifiable private information or identifiable biospecimens, and a new requirement for the posting of consent forms for certain federally-funded clinical trials.

See Also

• Belmont Report
• Declaration of Helsinki
• Nuremberg Code