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USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors

The U.S. Food and Drug Administration (FDA) released its final guidance this Tuesday (15 August 2023), "Informed Consent: Guidelines for IRBs, Clinical Investigators, and Sponsors".

The purpose of this guidance is to help institutional review boards (IRBs), clinical investigators, and sponsors comply with their responsibilities regarding informed consent when conducting clinical trials of FDA-regulated products.

The guidance begins with a description of the FDA's requirements for informed consent, followed by a discussion of IRBs, clinical investigators, sponsors, and FDA's roles in informed consent, followed by a number of frequently asked questions.

Informed consent is often misunderstood to mean getting an individual's signature on a consent form, when in fact getting evidence of an individual's informed consent is only one aspect of the consent process.

The concept of informed consent involves providing prospective subjects, or their legally authorized representative (LAR), with adequate information so they can make an informed decision before enrolling in the study.

Also, informed consent requires that the prospective subject is provided with adequate opportunity to ask questions and determine if he or she wishes to participate, obtain the subject's voluntary consent before enrollment, and continue to provide information as the clinical investigation progresses or as the subject or situation requires.

The informed consent process and consent form must meet the general requirements of 21 CFR 50.20 and must include the basic elements of informed consent required by 21 CFR 50.25(a) and FDA regulations identify eight basic elements of informed consent to be provided to the subject (21 CFR 50.25(a)).

To know more exclusively about the frequently asked questions related to Informed Consent, click this LINK.


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