Elements of Informed Consent Described in Federal Regulations

National Human Genome Research Institute

National Institutes of Health
U.S. Department of Health and Human Services

Elements of Informed Consent Described in Federal Regulations

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The eight basic required elements of informed consent can be found in the HHS regulations (45 CFR 46.116)

These elements include:
The regulations (45 CFR 46.116) also suggest inclusion of the following elements where appropriate:

Study investigators are not limited to including the 14 elements listed above. Any information that might be useful for the individual as he or she decides whether or not to take part in the study should be included. Furthermore, an institution's Institutional Review Board (IRB) may require additional elements that are not specifically listed in the regulations to ensure that adequate information is presented in accordance with institutional policy and law.


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Last Reviewed: November 15, 2012