FDA Revises Informed Consent Form Requirements

The FDA has updated regulations that require additional language to informed consent form (ICF) documentation.  21 CFR 50.25(c) was updated on January 4, 2012 requiring that the informed consent document disclose the sponsor’s posting of clinical trial information on www.clinicaltrials.gov.  The deadline for this change will take place for applicable studies that are initiated on or before March 7, 2012.

The FDA clearly stated that this requirement will not be applied retroactively to those studies that were initiated prior to March 7, 2012 and defined which studies were required to contain the new language.  The following statement must be reproduced word-for-word in informed consent documents:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law[1].  This Website will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this Web site at anytime.”

For more information about the FDA’s ICF deadline or a list of clinical trials that apply to this regulation, please visit (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf).

 For an updated Informed Consent Form checklist including the new regulation, you can contact Christina Billias at cbillias@harrisonirb.com .

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[1] For more information about the U.S. Law, please refer to Section 801 of FDAAA.