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In Brief: Patient Informed Consent

This article was originally published in The Gray Sheet

Executive Summary

Patient Informed Consent: FDA publishes final rule amending current informed consent regulations in a Nov. 5 Federal Register notice. The final rule, which takes effect Dec. 5, requires that consent forms be signed "by the subject or the subject's legally authorized representative" and "be dated by the subject or the subject's legally authorized representative at the time consent is given," according to the register. FDA has had problems verifying that patient consent was obtained before study participation ("The Gray Sheet" Jan. 1, In Brief). The final rule also amends case history regulation "to clarify what adequate case histories include and to clarify that these case histories must document that consent was obtained prior to participation in a study"...
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