FDA allows greater flexibility for clinical investigators about informed consent

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The U.S. Food and Drug Administration, FDA, proposes to allow greater flexibility for clinical investigators about informed consent in minimal risk situations. The proposal also suggests an exception to informed consent requirements for certain FDA-regulated clinical investigations: if they present no more than minimal risk to human research participants. Comments on this proposed rule can be submitted to FDA either in electronic or written form by January 14, 2019. The agency is also seeking input on the types of minimal risk clinical investigations for which sponsors or investigators would anticipate requesting a waiver or alteration of informed consent from the IRB.

Obtaining informed consent from those who volunteer to participate in clinical trials is a fundamentally important principle of human subject protection. The quality and integrity of clinical research data is something FDA takes very serious. But the protection of research individuals is paramount. Recently, the agency received feedback from sponsors and investigators. They were not able to move forward in conducting important clinical investigations with minimal risk. These trials involved situations where obtaining informed consent wasn’t possible. Until now, FDA lacked the authority to permit a waiver of informed consent for that research. According to the FDA proposing a change to the informed consent regulations - and still maintaining safeguards to protect study participants - would facilitate the conduct of certain minimal risk clinical investigations.

Exception from informed consent requirements for minimal risk clinical investigations

The proposed rule, if finalized, would allow the Institutional Review Board (IRB) responsible for the review and approval of the research to waive or alter certain elements of informed consent. It could also waive the requirement to obtain informed consent entirely, under limited conditions. To waive or alter informed consent under the proposal would be possible provided the IRB finds and documents the following:

• The clinical investigation 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 clinical investigation could not practicably be carried out without the waiver or alteration; and
• Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The FDA intends to withdraw its related 2017 guidance if the proposed rule entitled Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations becomes final.