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Exculpatory Language in Informed Consent August 2011


Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

This draft guidance has been prepared jointly by the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This document applies to non-exempt human subject research conducted or supported by the Department of Health and Human Services (HHS) and is intended for clinical investigators, institutional review boards, and funding agencies that may be responsible for review or oversight of human subject research conducted or supported by HHS. This document also applies to human subject research regulated by FDA and is intended for clinical investigators, sponsors, and institutional review boards conducting or reviewing such research.

This document provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent.  The document includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory.  When finalized, this document will supersede OHRP’s November 15, 1996, guidance entitled, “‘Exculpatory Language’ in Informed Consent” and question number 52 in FDA’s January 1998 guidance entitled, “Institutional Review Boards Frequently Asked Questions – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.”  

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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