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FDA has stated the guidance is intended to assist institutional
review boards (IRBs), clinical investigators, and sponsors in
complying with FDA's informed consent regulations for clinical
investigations.
This guidance supersedes FDA's guidance entitled "A
Guide to Informed Consent," issued in September 1998, and
finalizes FDA's draft guidance entitled "Informed Consent
Information Sheet," issued in July 2014.
The guidance presents general information 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. The guidance includes detailed descriptions of the
content needed for an informed consent, specific responsibilities
for the IRB, Clinical Investigator, sponsor and FDA. The Guidance
also includes 16 frequently asked questions.
It is critically important to provide prospective participants
in a clinical study with adequate information to allow for an
informed decision about the study prior to enrollment.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
