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Comments on the FDA’s Proposed Rule for Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

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Public Citizen is deeply concerned that once the Food and Drug (FDA) finalizes the proposed rule, clinical investigators inappropriately will seek, and IRBs inappropriately will grant, waivers of informed consent for clinical investigations that involve greater than minimal risk to the subjects.

View our other work related to ethics and clinical trials.