FDA seek to harmonize human subject protections with revised Common Rule

Regulatory NewsRegulatory News | 27 September 2022 |  By 

The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Common Rule, which contains requirements for protection of human subjects in research conducted or supported by the US Department of Health and Human Services.
The Federal Policy for the Protection of Human Subjects (known as the Common Rule) went into effect in 1991 and was revised in 2017. Previously, FDA released guidance for industry on how to handle differences in the revised Common Rule and rules on FDA-regulated research. FDA also addressed some differences with the revised Common Rule in a proposed rule focused on IRB waiver or alteration of informed consent for minimal risk clinical investigations, issued in November 2018. (RELATED: Differences Between HHS and FDA Clinical Trial Rules Spark New Guidance, Regulatory Focus 12 October 2018)
In the two proposed rules released by FDA on 27 September 2022, the agency outlines changes to the informed consent form and allows IRBs to eliminate continuing review of research in certain circumstances. The agency also proposes requiring a single IRB review process for multisite research conducted in the US, with some exceptions.
“FDA believes that these proposed changes, if finalized, would help ensure clarity and enhance both human subject protection and the IRB review process. In addition, harmonizing with the revised Common Rule would reduce regulatory burden for IRBs, sponsors, and investigators,” the agency wrote in the proposed rule on protection of human subjects and IRBs.
Human subject protection changes
If finalized, the proposed rule on protection of human subjects and IRBs would require that the informed consent form present key information in a concise way to assist prospective subjects in understanding if they might want to participate in research. FDA would also add basic and additional elements of informed consent, such as requiring:
  • A description of how information or biospecimens may be used for future research or distributed for future research.
  • A statement that private information or biospecimens collected during research may be used for commercial profit, and a notification of whether the research subject would share in the profit.
  • A statement of whether clinically relevant results will be disclosed to study subjects and under what circumstances.
  • A notification of whether the research involves whole genome sequencing (for research involving biospecimens).
The proposed rule also seeks to eliminate the requirement for IRBs to conduct “continuing review” of research under certain circumstances. The elimination of continuing review of research would apply to research that has progressed to the point that it only involves data analysis (including analysis of identifiable private information or biospecimens), and/or accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. “In these circumstances, FDA believes that requiring continuing review would generally not provide added protection to human subjects, and therefore, would not be necessary,” the agency wrote in the proposed rule.
The proposed rule would also revise FDA’s regulations on investigational device exemptions (IDEs) to clarify and update requirements for the submission of progress reports for clinical investigations of devices. Currently, investigators must submit progress reports to the sponsor, the monitor, and the reviewing IRB at regular intervals, at least annually. Under the proposed rule, investigators would not have to submit progress reports to the IRB if continuing review of the research by the IRB is not required.
Additionally, sponsors would not have to submit progress reports to the IRB if continuing review of the research is not required. However, sponsors would still have to submit regular progress reports to the FDA, at least annually, regardless of whether there is continuing IRB review. “FDA is proposing to maintain this reporting requirement for continued oversight of investigations that require submission of an IDE application to ensure the Agency receives information regarding the IDE investigation,” the agency wrote.
IRBs and cooperative research
In a second proposed rule, FDA seeks to harmonize its cooperative research requirements with those in the Common Rule, which requires a single IRB review process for multisite research conducted in the US, with some exceptions. FDA is proposing its own set of exceptions to the single IRB requirement for cooperative research, including:
  • Cooperative research in which more than single IRB review is required by law.
  • Cooperative research involving a highly specialized, FDA-regulated medical product that requires unique, localized expertise.
  • Cooperative research on drugs that are exempt from investigational new drug (IND) regulations.
  • Cooperative research on medical devices that meets the abbreviated requirements or the requirements for exempted investigations.
“FDA believes that, in many situations, mandatory single IRB review for multi-institutional clinical investigations would streamline the review process and increase efficiencies for the oversight of clinical investigations without compromising human subject protections. Increased efficiencies may facilitate faster initiation of clinical investigations supporting the development of new medical products to benefit the public health,” the agency wrote.
The agency requests that public comments on the proposed rules be submitted within 60 days of their publication in the Federal Register.
Proposed rule: Protection of Human Subjects and Institutional Review Boards
Proposed rule: Institutional Review Boards; Cooperative Research


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