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Comments on FDA Guidance Regarding IRB Waiver of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects

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Public Citizen urged the Food and Drug Administration (FDA) to issue expanded guidance that includes a discussion of the types of clinical investigations for which the agency might consider an institutional review board’s (IRB’s) waiver of informed consent to be appropriate from both an ethical and regulatory perspective.

See Public Citizen’s other work on ethics and clinical trials.