The Food and Drug Administration has issued a guidance entitled "IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects." This document provides guidance to sponsors, investigators, and institutional review boards (IRBs) on enforcement of FDA regulations governing informed consent requirements for clinical investigations that involve no more than minimal risk to human subjects.
The 21st Century Cures Act amended the Federal Food, Drug, and Cosmetic Act to provide authority for FDA to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. FDA intends to issue regulations to reflect this statutory change. Until FDA issues these regulations, this guidance informs sponsors, investigators, IRBs and other interested parties that FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, this guidance explains that FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance.
The guidance is now available on FDA’s website at: https://www.fda.gov/downloads/