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The Department is proposing revisions to 45 CFR part 46 to modernize and simplify subpart A, known as the Common Rule.  Changes are intended to uphold protections for human subjects while reducing burden and ambiguity for investigators, institutional review boards, and research institutions.  Examples of changes include clarifying terminology, expanding exemptions for certain low-risk research activities, and enabling flexibilities for regulatory review of de minimis protocol changes.  The Department will collaborate with the other Common Rule Departments and Agencies during this process.

Statement of Need:

The foundational framework for human subjects protection in the United States was established by the National Research Act of 1974 in response to widespread public concern over unethical biomedical and behavioral research practices.  Following its passage, the then-Department of Health, Education, and Welfare issued the first version of 45 CFR part 46.  These regulations established institutional review boards (IRBs) as the key mechanism for oversight and ethical review of human subjects research.  While these protections remain vital, the current regulatory framework no longer reflects the realities of modern research.

In 1991 the Federal Policy for the Protection of Human Subjects, known as the Common Rule, was formally adopted by HHS and 15 other federal departments and agencies.  Although the last major revision in 2017 introduced several changes to modernize human subject protections while reducing unnecessary regulatory burden, investigators and institutions have continued to report that the Common Rule imposes unnecessary burdens and unclear requirements, particularly for minimal-risk studies.  For example, the Department has received feedback that applying the Common Rule remains cumbersome for research within Learning Healthcare Systems and for other research methods that are integrated into clinical care settings and are intended to improve the quality and safety of medical care.

Without additional changes intended to clarify ambiguities, expand flexibilities, and redirect protective measures toward high-risk activities, the rights and safety of research participants as well as scientific breakthroughs can be impeded.  Examples of how this rulemaking will address these issues include expanding exemptions for certain additional types of low-risk research, incorporating flexibilities for de minimis protocol changes, and clarifying key terms such as the definition of undue influence.  These reforms will reduce ambiguity and undue administrative burden for institutions engaged in HHS-supported and conducted human research and will enable IRBs and human research protection programs to focus on those activities posing the greatest risk to human participants while reducing barriers to research that could benefit society.

Summary of the Legal Basis:

U.S. Code Title 42, Section 289 requires the Secretary of Health and Human Services (HHS) to establish regulatory requirements for human research protections, a program for guidance, and a process for responding to violations.  The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research was described in 42 USC 300v, and the reports and recommendations that were created by this commission were integral to the development and promulgation of the Common Rule. 

Alternatives:

The Department considered maintaining the current Common Rule framework without modification, as well as relying solely on subregulatory guidance or interpretive materials to clarify existing requirements. HHS determined that broader regulatory updates are necessary to improve consistency, reduce administrative burden, and ensure that oversight remains appropriately calibrated to the level of risk posed to research participants.

Anticipated Costs and Benefits:

The Department expects that the overall economic and social impact of this proposed rule will be deregulatory in nature and designed to improve efficiency, consistency, and proportionality of the rule’s application.  New costs attributable to this proposed rule would be associated with regulated entities’ obligations to comply with updated requirements.

The Department anticipates that this proposed rule would generate significant quantifiable and unquantifiable deregulatory benefits by improving efficiency and enabling a more risk-based application of human subjects protections requirements. By expanding flexibilities for low-risk research activities and clarifying existing requirements, the proposed rule is expected to reduce administrative burden on investigators, institutions, and institutional review boards while helping accelerate scientific discovery, improve healthcare delivery practices, and support more timely development of treatments and interventions that benefit public health.

Risks:

Potential risks include concerns from some stakeholders that expanded exemptions and additional regulatory flexibilities could reduce oversight for certain categories of research or create inconsistent implementation across institutions. The Department expects these risks to be mitigated through continued IRB oversight for higher-risk activities, existing human subject protections requirements, interagency coordination among Common Rule departments and agencies, and public engagement through the notice-and-comment process to ensure that participant protections remain strong while unnecessary burden is reduced.