November 19, 2018

FDA Issues Proposed Rule on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

In today’s edition of the Federal Register, the Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.”  FDA is proposing to amend its regulations to implement section 3024 of the 21st Century Cures Act.  This proposed rule, if finalized, would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects.  The proposed rule, if finalized, would permit an IRB to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.

 

The proposed rule can be accessed on FDA’s web site.  Comments on the proposed rule may be submitted at https://www.regulations.gov (Docket No. FDA-2018-N-2727) and are due by January 14, 2019.