Protection of Human Subjects and Institutional Review Boards

If finalized, the proposed rule would: (1) revise the content, organization, and presentation of information included in the informed consent form and process to facilitate a prospective subject’s decision about whether to participate in a clinical investigation1; (2) add new basic and additional elements of informed consent; (3) add a provision allowing IRBs to eliminate continuing review of some research; (4) revise IRB recordkeeping requirements for certain determinations related to the need for continuing review; and (5) add or modify some definitions. The rule also proposes to revise FDA’s regulations on investigational device exemptions (IDEs, 21 CFR part 812) to clarify and update the requirements for submission of progress reports for clinical investigations of devices.

The proposed rule would harmonize certain aspects of FDA’s regulations on IRBs and informed consent processes, to the extent practicable and consistent with statutory provisions, with the requirements of the “Federal Policy for the Protection of Human Subjects” (revised Common Rule)2 in accordance with section 3023 of the 21st Century Cures Act of December 13, 2016 (the Cures Act) (Public Law 114-255, 130 Stat 1033). The proposed rule would harmonize certain aspects of FDA’s regulations on IRBs and informed consent processes, to the extent practicable and consistent with statutory provisions, with the requirements of the “Federal Policy for the Protection of Human Subjects” (revised Common Rule)2 in accordance with section 3023 of the 21st Century Cures Act of December 13, 2016 (the Cures Act) (Public Law 114-255, 130 Stat 1033).

The benefits of the proposed rule take the form of quantified net cost savings (cost savings minus costs) and non-quantified benefits. We estimate that the benefits of the proposed rule (in the form of cost savings) are approximately $68 million annually in 2018 dollars, with a lower bound of approximately $22 million and an upper bound of approximately $249 million, discounted at 7 percent over 10 years. When discounted at 3 percent, estimated benefits are approximately $68 million annually, with a lower bound of approximately $22 million and an upper bound of approximately $249 million. We also expect benefits in the form of cost savings from increased efficiency in medical product innovation and improved human subject knowledge. We estimate that the costs of the proposed rule are approximately $1.4 million annually in 2018 dollars, with a lower bound of approximately $0.7 million and an upper bound of approximately $3.0 million, discounted at 7 percent over 10 years. When discounted at 3 percent, estimated costs are approximately $1.3 million annually, with a lower bound of approximately $0.6 million and an upper bound of approximately $2.6 million.

Regulatory Impact Analysis

Protection of Human Subjects and Institutional Review Boards (Proposed Rule) Regulatory Impact Analysis (PDF)

Federal Register: 87 FR 58733, September 28, 2022

Docket: FDA-2021-N-0286