But only if there’s minimal risk…so that’s ok then
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 21 December 2023 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”.
What this means is that for some research, where there is “minimal risk” to participants, the detailed and important process of explaining the study and getting each participant’s consent can be skipped. This can be done if the Institutional Review Board (IRB) waives or alters the informed consent elements.