Data / Federal rules / 2024-04377
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability
The Food and Drug Administration published this proposed rule in the Federal Register on March 1, 2024. Comments closed on April 30, 2024.
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What the agency says
The Office for Human Research Protections, Office of the Assistant Secretary for Health (OHRP), and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled "Key Information and Facilitating Understanding in Informed Consent." This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA's proposed rule "Protection of Human Subjects and Institutional Review Boards." FDA's proposed rule, if finalized, would harmonize certain sections of FDA's regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act (Cures Act). The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA's proposed rule.
Key facts
- Document number
- 2024-04377
- Type
- Proposed rule
- Action
- Notification of availability
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 1, 2024
- Comments due
- April 30, 2024
- Dates
- Submit either electronic or written comments on the draft guidance by April 30, 2024 to ensure that FDA and OHRP consider your comment on this draft guidance before the agencies begin work on the final version of the guidance.
- Docket
- Docket No. FDA-2022-D-2997
- Code of Federal Regulations
- 21 CFR 50
- Pages
- 3
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