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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.
1 lut 2022 · This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biological products.
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 ...
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.
On August 15, 2023, FDA published a final guidance entitled, “Informed Consent, Guidance for IRBs (Institutional Review Boards), Clinical Investigators, and Sponsors.”. This final guidance supersedes the September 1998 guidance entitled “A Guide to Informed Consent” and replaces the July 2014 draft guidance “Informed Consent ...
24 sie 2023 · On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued a new guidance document on informed consent (the “Final Guidance”). 1 This guidance finalizes the draft “Informed Consent Information Sheet” from 2014 (the “Draft Guidance”) and supersedes FDA’s guidance from 1998, “A Guide to Informed Consent.” 2 FDA ...
6 wrz 2023 · The FDA offers guidance on specific areas that IRBs should consider when reviewing and approving consent forms for compliance with FDA regulatory requirements, and to ensure that the informed consent process adequately protects the rights and welfare of subjects participating in the clinical investigation:
