FDA Proposed Rules Aim to Modernize, Improve Protections for Clinical Research Participants

December 6, 2022

The Association for Clinical Oncology (ASCO) provided comment letters in response to two U.S. Food and Drug Administration (FDA) proposed rules that aim to harmonize clinical research regulations with the Department of Health and Human Services’ (HHS) revised Common Rule, the federal policy for the protection of human research subjects.

The purpose of the Common Rule is to create a uniform body of regulations across all federal departments and agencies to promote the safety of human research participants. The revised Common Rule, which went into effect in 2019, is intended to both better protect humans participating in research, and reduce burden, delay, and ambiguity for the research and clinical care communities.

One proposed rule would require the use of a single Institutional Review Board (IRB) for clinical studies with multiple institutions or research sites. This would aim to reduce the administrative burden for clinical investigators and IRBs, enabling research to begin earlier without compromising clinical trial participants. If this enhancement is finalized, it would support more efficient research and medical product development to help meet critical patient needs for new treatment options in a more efficient manner. ASCO supports this proposal, as it carries out administrative changes included in the 21st Century Cures Act, such as adopting a single IRB approach for review and approval of research conducted in the United States. Furthermore, ASCO agrees that single IRB reviews for multi-institutional clinical investigations would streamline the review process, help eliminate administrative burdens that delay access to research, and increase oversight inefficiencies.

The other proposed rule focuses on the protection of human subjects and IRBs. The proposal aims to enhance the informed consent process for individuals who are considering participating in clinical trials to help them decide whether they should participate in the trial. The proposal would revise the requirements on informed consent, the organization and presentation of information provided in the consent form, and require that key information—which is most likely to help a potential participant understand the study—is presented before any other information about the study. ASCO strongly supports this proposal, and comments on the importance of the FDA aligning with the revised Common Rule to waive informed consent documentation for a study with no more than minimal risk of harm to participants.

The FDA also proposed broadening the diversity of IRB members, by considering various professional qualifications along with other factors including but not limited to race, gender identity, and cultural backgrounds, which ASCO supports.

ASCO’s comments do note potential limitations and needed flexibilities that the FDA must consider as it continues its work to better protect clinical research participants. However, the Association is pleased to see the FDA begin to align itself with the revised Common Rule, and ASCO will continue to work with the agency as it continues to advance its such efforts.

For additional updates on ASCO’s work with federal agencies, bookmark ASCO in Action.