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Elements of informed consent

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Federal regulations at 45 CFR 46 and 21 CFR 50 includes a list of basic elements required to be provided to the participant when seeking their Informed Consent (IC). Additional elements are also described that may be applicable to the research. Common Rule, 2018 Requirements: 45 CFR 46.116, General Requirements for Informed Consent; FDA: 21 CFR 50.25, Elements of Informed Consent


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