Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects; Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability

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The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for sponsors, investigators, and institutional review boards (IRBs) entitled "IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects." This guidance informs sponsors, investigators, IRBs, and other interested parties that FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, this guidance explains that FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance.