Vaccine Data War, 2024 (General)

by dan, Wednesday, July 10, 2024, 10:16 (13 days ago) @ dan

Here is the rule:

Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

B. Summary of the Major Provisions of the Final Rule

The final rule amends FDA's regulations to allow IRBs responsible for the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations. For an IRB to approve a waiver or alteration of informed consent requirements for minimal risk clinical investigations, the rule requires an IRB to find and document five criteria that are consistent with the revised rule entitled “Federal Policy for the Protection of Human Subjects” (the revised Common Rule (January 19, 2017)).


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