Building on a 2017 guidance that offered new, relaxed conditions for some informed consent waivers, the U.S. Food and Drug Administration (FDA) has now released a new rulemaking notice allowing researchers in what have been deemed low-risk clinical trials to experiment on patients without obtaining informed consent—if those trials meet at least four conditions.
The agency will grant waivers if researchers can prove that the trial presents “no more than minimal risk,” won’t harm patients’ health or rights, cannot be carried out without such a waiver, and will deliver a complete post-study report to the patients involved.
The major provisions of the proposed rule would allow institutional review boards (IRBs) responsible for “the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that waives or alters certain informed consent elements or that waives the requirement to obtain informed consent for certain minimal risk clinical investigation,” FDA explained in its notice in the Federal Register.
FDA believes the proposed rule “would provide appropriate safeguards to protect the rights, safety, and welfare of the human subjects participating in such clinical investigations.”
Author: Michael Causey
Webinar Replay — Waiving or Altering Consent for Minimal Risk Trials
Free for ACRP Members! Make sure you are prepared for the new opportunities this policy change will open to your research teams. This course will help you describe existing regulatory exception to informed consent, define minimal risk as it pertains to waiver or alteration of informed consent by the IRB, and list the four criteria the IRB must document in order to grant an alteration or waiver of informed consent.