Common Rule

Common Rule
Name	Common Rule
Established	1991 (revised 2018)
Jurisdiction	United States
Subject	Human subjects research regulations
Administered by	Department of Health and Human Services; Federal agencies

Common Rule The Common Rule is the baseline federal policy for the protection of human subjects in research involving many U.S. federal agencies and departments. It sets standards for informed consent, institutional oversight, and review procedures applied across a range of research programs sponsored by agencies such as the Department of Health and Human Services, the Department of Defense, and the National Science Foundation. The rule informs practices at institutions including universities, medical centers, and private research organizations and interacts with statutes, case law, and professional standards shaped by events such as the Nuremberg Trials and policy responses like the Belmont Report.

History and development

The regulatory framework emerged from historical episodes and reports linking ethical abuses to formalized protections. Early influences included the Nuremberg Trials, the Declaration of Helsinki, and the Tuskegee Syphilis Study scandal, which prompted the National Research Act and the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report provided foundational ethical principles for subsequent rulemaking. Federal rulemaking in the 1970s and 1980s across agencies such as the National Institutes of Health, the Food and Drug Administration, and the Veterans Health Administration converged into a harmonized policy, codified in the Federal Policy for the Protection of Human Subjects and promulgated in 1991. Major revisions were issued after interagency notice and comment, culminating in the 2017-2018 revisions addressing informed consent, single IRB mandates for multisite research, and data protection provisions influenced by advances in genomics at institutions like Broad Institute and programs such as the Human Genome Project.

Scope and applicability

The rule applies to research conducted or supported by participating federal departments and agencies, including the Department of Health and Human Services, the Department of Defense, the Department of Education, and the Environmental Protection Agency. It covers a broad range of human subjects research carried out at entities such as Harvard University, the Mayo Clinic, the Johns Hopkins Hospital, and private contractors. Certain activities and categories receive exclusions or exemptions; exclusions may involve activities regulated under statutes like the Privacy Act of 1974 or specific agency authorities such as the Food, Drug, and Cosmetic Act, while exemptions often pertain to educational settings at institutions like Stanford University or benign behavioral interventions described in guidance from agencies including the Office for Human Research Protections. International research involving institutions such as the World Health Organization or collaborations with sites like University College London must reconcile local laws and the rule’s applicability when federal funding or collaboration is involved.

Key provisions and requirements

Core requirements include informed consent documentation and process standards, criteria for Institutional Review Board (IRB) approval, and special protections for vulnerable populations identified in the Belmont Report such as children, prisoners, and pregnant women. The rule prescribes elements of consent similar to provisions in statutes like the Common Rule’s regulatory text and aligns with interpretive guidance from agencies including the Centers for Disease Control and Prevention and the National Institutes of Health. It requires that risks be minimized consistent with sound research design, benefits justified, and confidentiality safeguarded through mechanisms like data use agreements used by programs such as the All of Us Research Program. The 2018 revisions introduced categories for exempt research, new consent form requirements, and mandates for single IRB review in multisite studies, affecting cooperative groups such as the Children's Oncology Group and networks like the Clinical and Translational Science Awards consortium.

Institutional review boards and oversight

Institutional Review Boards are the primary oversight bodies charged with review and approval of research under the rule. IRBs operate at universities such as Columbia University, hospitals such as Massachusetts General Hospital, independent review organizations like Western Institutional Review Board, and federal laboratories including Los Alamos National Laboratory when human subjects are involved. Board composition, quorum, conflict-of-interest rules, and continuing review procedures reflect regulatory text and guidance issued by agencies such as the Office for Human Research Protections and are informed by case law from courts including the Supreme Court of the United States in matters affecting federal oversight. Many institutions use compliance offices modeled on programs at Yale University or Duke University to coordinate IRB functions, training requirements like those of the Collaborative Institutional Training Initiative, and reporting obligations to entities including the Office of Inspector General.

Compliance, enforcement, and penalties

Compliance is monitored through audits, site visits, and reporting requirements enforced by federal agencies including the Department of Health and Human Services’s Office for Civil Rights for privacy-related matters and the Food and Drug Administration for regulated clinical trials. Noncompliance can lead to administrative actions such as suspension of research, termination of funding by agencies like the National Science Foundation or the National Institutes of Health, debarment, or civil and criminal penalties under statutes enforced by the Department of Justice when fraud or willful violations occur. Institutions have developed internal corrective action plans informed by precedents involving entities like University of Pennsylvania and Rutgers University and by guidance from oversight bodies such as the Government Accountability Office.

Criticisms and reforms

Scholars, professional societies, and advocacy groups including the American Medical Association, the American Psychological Association, and patient advocacy organizations have criticized the rule for bureaucratic burdens, inconsistent multi-site review, and challenges to pragmatic and social-behavioral research. Proposals for reform have come from commissions and advisory panels tied to institutions like the National Academies of Sciences, Engineering, and Medicine, think tanks such as the Brookings Institution, and legislative initiatives debated in the United States Congress. Debates focus on balancing participant protections with research efficiency, data privacy in light of projects like the UK Biobank and the All of Us Research Program, and ethical considerations raised by emerging technologies developed at centers such as MIT Media Lab and Carnegie Mellon University. Ongoing rulemaking and policy discussions involve federal agencies, academic consortia, and international collaborators including the Council for International Organizations of Medical Sciences.

Category:United States administrative law