11/20/2018

The U.S. Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” The NPRM seeks to amend regulations 21 CFR Parts 50, 312, and 812 in alignment with provisions in the 21st Century Cures Act (Cures Act).

In a statement by FDA Commissioner Scott Gottlieb, M.D., he explains that there have been concerns from investigators and sponsors about an inability to conduct some minimal risk clinical trials because informed consent was not feasible and they did not meet the requirements for a waiver. If finalized, the proposed rule would allow Institutional Review Boards (IRBs) to waive parts of or the whole informed consent in certain minimal risk clinical trials. They would follow the Common Rule’s waiver provisions:

The research involves no more than minimal risk to subjects;
The research could not be carried out practicably without the waiver or alteration;
The waiver or alteration will not adversely affect the rights and welfare of the subjects; and,
Where appropriate, the subjects will be provided with additional information about their participation.
The Revised Common Rule adds: If the research involves identifiable private information or identifiable biospecimens, this research could not be carried out practicably without using the information/specimen in an identifiable form.

There is currently a 2017 guidance, “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects” that would be withdrawn if the proposed rule is finalized. If finalized, the proposed rule would reduce burdens to sponsors and investigators while still ensuring human subject protections.

Public comments can be made here and are due by January 14, 2019.

- The Clinical Pathways Team

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