Informed Consent Additional Resources

National Human Genome Research Institute

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

Informed Consent Additional Resources

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Requirements for Human Subjects Research

OHRP has tips for informed consent at Tips On Informed Consent [] and at OHRP Informed Consent Frequently Asked Questions []. OHRP also has tips for other elements of the research process at Human Research Questions & Answers []

The regulations apply to any clinical trial that involves an investigational drug, biological product, or other device that is regulated by the FDA under the Food, Drug, and Cosmetics Act - regardless of whether or not the trial receives Federal funding. If a trial is supported by the Department of Health and Human Services and involves an FDA-regulated drug or device, then it is subject to both organizations' regulations. (For more information, see Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors []).

Guidance Documents

Additional Consent Form References and Examples

Other Organizations and Resources

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Last Updated: March 18, 2014