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FDA Works to Make Informed Consent Easier to Understand (Catapult’s regulatory round-up – March 2024)

It is the research community’s ethical obligation to ensure that individuals who participate in research understand the purpose and the potential risks and benefits of the research before agreeing to participate. Too often, however, informed consent forms are difficult for potential research participants to understand. To improve this informed consent process, the FDA and the Office for Human Research Protections have published a draft guidance titled “Key Information and Facilitating Understanding in Informed Consent.” This guidance is intended to assist institutional review boards (IRBs), investigators, and sponsors engaged in or responsible for oversight of human subject research subject to FDA and/or Health and Human Services (HHS) regulations with the development of consent information that would comply with 45 CFR 46.116(a)(5) and FDA’s proposed revisions to 21 CFR 50.20(e), if finalized as proposed. Electronic and written comments can be submitted until 1st of May 2024.

Published on the 2nd of April 2024 in Catapult’s regulatory round-up for March 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA Works to Make Informed Consent Easier to Understand (Catapult’s regulatory round-up – March 2024). ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/12miy


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