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

Requirements for Human Subjects Research

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

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 [fda.gov]).

Guidance Documents

Additional Consent Form References and Examples

Other Organizations and Resources

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Last Updated: March 18, 2014