FDA Exception from the Requirement to obtain Informed Consent

Recommendation

7/8 May 2024

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The FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of trial participants. The rule provides an exception from the requirement to obtain informed consent when a clinical trial poses no more than minimal risk to the people participating in the trial, and the research includes appropriate safeguards to protect the rights, safety and welfare of the participants.

The final rule permits an institutional review board (IRB) to waive or alter certain elements of informed consent, or to waive the requirement to obtain informed consent entirely, under limited conditions, for certain FDA-regulated clinical trials. The rule continues to protect the rights, safety and welfare of trial participants and enables minimal risk clinical investigations that may facilitate medical advances and promote public health.
According to the FDA, "these efforts will promote additional robust clinical research to generate the evidence needed to inform clinical decision making and ultimately enhance treatment and diagnostic options for patients".

The agency believes that this new rule will enable minimal risk research that would not be practicable to conduct otherwise. This could include, for example, studies comparing the effectiveness of approved products to determine which option works best for certain patients.  

For more information please see FDA's final rule Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.