Thursday, February 1, 2024

FDA Quietly Removes the Need for Informed Consent in Some Clinical Investigations

 In 2023, the Food and Drug Administration (FDA), together with the Department of Health and Human Services (HHS) began the process of amending a provision of the 21st Century Cures Act (Cures Act). This involved taking and assessing comments which was done last year. The rule was then published on before becoming effective on 22 January 2024. Did you hear about it in the news? I didn’t think so.

The final rule “allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety and welfare of human subjects”.