On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...
Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to amend Agency regulations to allow Institutional Review Boards (“IRBs”) to waive or alter certain informed consent elements (or in some cases, waive the informed consent requirement altogether) for FDA-regulated, minimal risk clinical investigations (“Proposed Rule”).
What Clinical Investigations are Affected?
Importantly, the only clinical investigations affected by the Proposed Rule are those that are FDA-regulated and ...
The passage of the 21st Century Cures Act ("Cures Act") and revisions to the Common Rule (45 CFR Part 46) ("Common Rule") in the last year mandated significant changes to informed consent laws. As a result of these changes, sponsors of research ("Sponsors"), institutions conducting research ("Institutions"), and the institutional review boards ("IRBs") approving research will need to review policies and practices involving informed consent. As explained below, a recently published FDA guidance document makes a first step toward implementing some of these changes by ...
On July 15, 2014, the U.S. Food and Drug Administration ("FDA") released draft guidance that provides extensive commentary on FDA's current thinking regarding the clinical trial informed consent process. Once finalized, this document, entitled "Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors" ("Draft Guidance"), will replace FDA's 1998 informed consent guidance, "A Guide to Informed Consent."
Although the Draft Guidance is largely consistent with current practices a number of FDA's recommendations signal the modification ...
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