FDA Proposed Rule Allows Waiver of Informed Consent If IRB Finds Risk Is Minimal

November 15, 2018By Jeffrey K. Shapiro

The informed consent requirements in drug and device trials are important for subject protection. But there are trials where it is not possible (or difficult) to obtain consent, and the risk to subjects is minimal.

Until recently, these trials could not go forward. In the 21st Century Cures Act, Congress stepped in.  Section 3024 amends drug and device provisions in the Federal Food, Drug, and Cosmetic Act that require informed consent for clinical studies to allow a waiver, if the testing poses “no more than minimal risk” to the subjects and/or the investigator and has “appropriate safeguards.” It is left to FDA to fill out the details.

FDA has just announced a proposed rule. As the FDA Commissioner, Scott Gottlieb, M.D., explains:

Over the years, we’ve received feedback from sponsors and investigators that they were not able to move forward in conducting important clinical investigations where there would be minimal risk as these trials involved situations where obtaining informed consent wasn’t possible, and the agency lacked the authority to permit a waiver of informed consent for that research. With the passage of the 21st Century Cures Act, the FDA’s authorities were changed, allowing greater flexibility. That’s why today, we’re proposing a change to our informed consent regulations in a way that maintains safeguards to protect study participants, while allowing important research to proceed where there is minimal risk to patients.

The proposed rule would defer to institutional review boards (IRBs) to make the waiver decision. To waive informed consent, IRBs must find:

  • The research involves no more than minimal risk to the subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the waivers or alterations; and
  • Whenever appropriate, the subjects will be provided with additional patient information after participation.

In 2017, FDA issued guidance to similar effect based upon passage of the Cures Act. It will be withdrawn when the newly proposed rule becomes final.  Comments on the proposed rule are due by January 14, 2019.