Informed Consent

20
Dec
FDA Finalizes Rule for Waiver or Alteration of Informed Consent in Limited Circumstances

FDA Finalizes Rule for Waiver or Alteration of Informed Consent in Limited Circumstances

After more than five (5) years since the introduction of the proposed rule, FDA is issuing a final rule that adds § 50.22 Exception from informed consent requirements for minimal risk clinical investigations to the regulations. “The final rule amends FDA’s regulations to allow [Institutional Review Boards] IRBs responsible for the review, approval, and continuing […]

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