By Danielle
The U.S. Food and Drug Administration (FDA) has finalized a rule that removes the requirement to obtain informed consent for medical research.
“This 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,” the rule reads.
The rule went into effect on January 22, 2024.
Just so you know the FDA and HHS made it so that “informed consent” could be waived by IRB’s. The new rule went into effect two days ago. pic.twitter.com/2z8DMNVMeT
— Champagne Joshi (@JoshWalkos) January 25, 2024
A closer look:
From the Federal Register:
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This 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. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
The FDA received critical comments opposing the rule, stating that “waiving consent conflicts with existing ethical and international standards, such as the Belmont Report, the Nuremberg Code, the Declaration of Helsinki, and the International Covenant on Civil and Political Rights (ICCPR).”