The Common Rule is a federal policy in the United States that establishes ethical standards and guidelines for the protection of human subjects in research conducted or supported by federal agencies. Formally known as the “Federal Policy for the Protection of Human Subjects,” the Common Rule was first published in 1991 and has since been adopted by multiple federal departments and agencies, including the Department of Health and Human Services (HHS), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA).
The key provisions of the Common Rule include:
- Institutional Review Boards (IRBs): The Common Rule requires that all research involving human subjects be reviewed and approved by an Institutional Review Board (IRB) to ensure that the research meets ethical standards and that the rights and welfare of the research participants are protected. IRBs are composed of scientists, non-scientists, and community representatives who collectively evaluate the risks and benefits of the research and oversee its conduct.
- Informed consent: The Common Rule mandates that researchers obtain informed consent from all human subjects participating in research. This process involves providing potential participants with comprehensive information about the research, including its purpose, procedures, potential risks and benefits, and any alternatives. Participants must voluntarily agree to participate in the research, and they have the right to withdraw their consent at any time.
- Risk-benefit analysis: The Common Rule requires that research involving human subjects be designed to minimize risks to the participants while maximizing potential benefits. IRBs evaluate the risk-benefit ratio of proposed research projects and ensure that risks are reasonable in relation to the potential benefits.
- Protection of vulnerable populations: The Common Rule includes special provisions to protect vulnerable populations, such as children, pregnant women, prisoners, and individuals with cognitive impairments, who may be at increased risk of coercion or exploitation in research. Additional safeguards are required for research involving these populations to ensure their safety and welfare.
- Privacy and confidentiality: The Common Rule emphasizes the importance of protecting the privacy of research participants and maintaining the confidentiality of their data. Researchers must implement measures to prevent unauthorized access, use, or disclosure of personal information collected during the research process.
- Assurance of compliance: Institutions conducting research involving human subjects are required to provide written assurance to the relevant federal agency that they will comply with the Common Rule and any additional regulations or guidelines pertaining to the protection of human subjects.
The Common Rule has been periodically updated to address emerging ethical issues and improve the efficiency and effectiveness of the human subjects’ protection system. In January 2017, the Final Rule was issued, which included revisions to the Common Rule aimed at enhancing the protection of research participants while reducing administrative burdens for researchers and institutions. The revised Common Rule went into effect on January 21, 2019.