FDA Releases Draft Guidance for IRBs, Clinical Investigators, and Sponsors on Informed Consent Information Sheet

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This guidance document is being distributed for comment purposes only.

Informed Consent Information Sheet

Guidance for IRBs, Clinical Investigators, and Sponsors


About this Guidance Document

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's or Agency's) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number listed under "For Questions Regarding This Document" below.


How to Comment

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.  Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For Questions Regarding this Document

For questions regarding this draft document contact (OGCP) Marsha Melvin at [email protected], (CDER) Kristen Miller at 301-796-0762, (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 240-402-7800, or (CDRH) Sheila Brown at 301-796-6563 (CDRH).

To Obtain Copies of This Document

Additional copies are available from:

Office of Good Clinical Practice
Office of Special Medical Programs, Office of Medical Products and Tobacco
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
(Tel) (301) 796-8340

FDA Offices Issuing This Guidance

U.S. Department of Health and Human Services
Food and Drug Administration
Office of Good Clinical Practice
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health


You can read the guidance here.