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15 sie 2023 · This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations.
FDA has issued guidance regarding IRB waiver or alteration of informed consent for certain clinical investigations involving no more than minimal risk. See FDA “Guidance for Sponsors ...
The Investigational Device Exemptions (IDE) regulation (21 CFR 812) describes three types of device studies: significant risk (SR), nonsignificant risk (NSR), and exempt studies. In this guidance...
This document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions.
This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA’s informed consent regulations. This guidance, when finalized, will supersede “A Guide to Informed Consent,” issued in September 1998, by the Office of Health Affairs, FDA.
Regulatory Compliance. What You Should Know About FDA Final Informed Consent Guidance. On August 15, 2023, FDA published a final guidance entitled, “Informed Consent, Guidance for IRBs (Institutional Review Boards), Clinical Investigators, and Sponsors.”
The final guidance supersedes FDA’s 1998 final guidance, “A Guide to Informed Consent,” and finalizes the 2014 draft guidance, “Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors,” with additional examples and illustrations.
