The Food and Drug Administration is seeking to clarify and strengthen rules under which clinical emergency research can be conducted without the informed consent of patients. The agency has issued new draft guidance on the topic and plans to hold a public hearing on Oct. 11. The new guidance details the requirements and procedures for conducting clinical experiments under a 1996 emergency waiver rule (21 CFR 50.24). The rule allows research without the informed consent of incapacitated subjects or their legal representatives in life-threatening situations in which informed consent is not feasible and available treatments are unproven or unsatisfactory. IRBs must have previously consulted with community representatives and publicly disclosed that incapacitated individuals can be enrolled without their consent. The guidance provides far more detail than was previously offered on the roles of sponsors, clinical investigators and IRBs, and also broadens and clarifies the meaning of community consultation and public...

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