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The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical investigations.On December 21, 2023, FDA issued a final rule providing 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. This rule permits an IRB to approve an informed consent procedure that waives or alters certain informed consent elements or waives the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal-risk clinical investigations—provided the IRB has found and documented five criteria consistent with the revised Federal Policy for the Protection of Human Subjects ("Common Rule"). ...The final rule requires an IRB to find and document five Common Rule criteria in order to permit a waiver or alteration of the informed consent requirements: The clinical investigation involves no more than minimal risk to subjects; It could not practicably be carried out without the requested waiver or alteration; If the clinical investigation involves identifiable private information or identifiable biospecimens, it could not practicably be carried out without using such information or biospecimens in an identifiable format; The waiver or alteration will not adversely affect subject rights and welfare; and Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation. The final rule takes effect on January 22, 2024.
