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# FDA Denies Petition to Amend Inform Consent Documents
- URL: https://www.fdaweb.com/fda-denies-petition-to-amend-inform-consent-documents/
- Published: 2017-04-18T12:00:00.000Z
- Updated: 2026-09-14T22:18:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138469

FDA has denied a 5/30/14 Center for Responsible Science petition asking that the agency amend its informed consent regulations to require specific standard warnings in informed consent documents for every phase of clinical trials. The [denial letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2014-P-0814-0021&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the petition asked for three specific standard warnings.

“We note that the petition does not provide any evidence to support the proposed warning language, such as study data demonstrating how the proposed warnings would be understood by prospective research subjects, and whether the warnings would effectively ameliorate the deficiencies asserted in the petition” the letter says. “However, because the proposed warnings raise broader concerns that make them inappropriate for inclusion in FDA’s existing informed consent regulations … we are denying your petition.”