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FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule

Image of a group of medical professionals having a meeting.

By: Hilary Marston, M.D., M.P.H., Chief Medical Officer and Ann Meeker-O’Connell, M.S., Director, Office of Clinical Policy 

Hilary Marston, M.D., M.PH.
Hilary Marston, M.D., M.PH.

Clinical trials play a crucial role in advancing science and supporting the development of new medical products to address unmet patient needs. Reliable data from well-designed trials about a medical product’s safety and effectiveness are critical to the U.S. Food and Drug Administration’s decision-making about a product’s benefits and risks. In general, clinical trials, particularly advanced stage trials, that enroll participants reflecting the diversity of patient populations will help make it possible to apply the findings from clinical trials to broader patient populations and maximize the public health impact of FDA cleared or approved products.

These clinical trials are only possible because of the people who volunteer to participate to help find new products to treat, prevent, or diagnose specific medical conditions. The FDA is committed to protecting clinical trial participants and helping to ensure that the clinical research enterprise welcomes a breadth of participants who receive relevant and accessible information about participating. It is with these goals in mind that we approach the modernization of the FDA’s oversight of clinical research and harmonizing with the U.S. Department of Health and Human Service (HHS) Common Rule to make clinical trials more efficient and improve information for potential participants. The Common Rule is a set of federal rules that protect people who participate in research. 

Modernizing and Enhancing Oversight of Clinical Research

Recently, the agency published two proposed rules that demonstrate the significant progress we’ve made toward harmonizing our human subject protection regulations with the HHS Common Rule for the kinds of research the FDA oversees and consistent with our other statutory requirements.

The first proposed rule, Institutional Review Boards: Cooperative Research, would generally require use of a single Institutional Review Board (IRB) for clinical studies with multiple institutions (research sites). This may reduce the administrative burden for clinical investigators and IRBs and allow research to begin earlier without compromising the safety of people participating in clinical trials. This enhancement, if finalized as proposed, should support more efficient research and medical product development to help meet critical patient needs for new treatment options more efficiently. 

Deciding whether to participate in a clinical trial can be difficult to navigate. The second proposed rule, Protection of Human Subjects and Institutional Review Boards, would enhance the informed consent process for people considering participating in clinical trials to help them decide whether they should participate in the trial. It would revise the requirements regarding the content, organization and presentation of information in the informed consent form, and require that key information most likely to help a potential participant understand the study be presented first before other information about the study. These changes should facilitate important discussions between a prospective clinical trial participant and their health care provider or other trusted advisor about whether a specific clinical investigation is an appropriate option. We also hope this will invite broader participation in clinical research, advancing our efforts to ensure that clinical trials reflect the diversity of patient populations and that these patient populations feel engaged by the clinical research community. 

Ann Meeker-O’Connell
Ann Meeker-O’Connell, M.S.

These proposed rules are open for public comment through November 28, 2022. The agency looks forward to receiving comments and input from stakeholders and will take all feedback under consideration as we work to finalize the rules and continue to modernize clinical research oversight. 

We are also currently working to finalize a previously issued proposed rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations. This rule is also part of our effort to harmonize with the Common Rule and, if finalized as proposed, is intended to help enable certain minimal risk clinical investigations for which the informed consent requirement is waived or certain elements of informed consent are waived or altered.

The Future of Clinical Research Oversight

Going forward, the FDA will continue to work with federal partners and clinical research stakeholders on our harmonization efforts related to protecting clinical trial participants. More generally, effective collaboration among the clinical research community is key to enhancing the design and conduct of clinical trials that provide the robust scientific evidence needed to advance new treatment options for patients. Supporting clinical trial modernization and protecting clinical trial participants will continue to be at the forefront of the FDA’s oversight of clinical research.


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