Barnes & Thornburg LLP Health Blog: New Requirements for Informed Consent Effective March 7, 2012

Barnes & Thornburg LLP Health Blog: New Requirements for Informed Consent Effective March 7, 2012


By Carolyn Metnick

In the Federal Register of January 4, 2011 (76 FR 256), the FDA published a final regulation amending the current informed consent regulation to require that informed consent documents and processes for applicable drug and device clinical trials include a specific statement that the trial information will be submitted for inclusion in the clinical trial registry data bank maintained by the National Institute of Health/National Library of Medicine. 

This regulation, set forth at 21 CFR §50.25(c), provides that every informed consent shall include the following statement:  "A description of this clinical trial will be available on, as required by U.S. Law. This web site 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 any time."  The statement is provided to inform applicable trial participants of the availability of the clinical trial information in the public domain and at the web site.  This requirement only pertains to "applicable clinical trials" as defined at 42 U.S.C. §282(j)(1)(A).   

According to FDA guidance, "applicable clinical trials" generally include controlled interventional studies of drugs, biological products or devices that are subject to FDA regulation, meaning that a trial has one or more sites in the United States, involves a drug, biologic, or devices manufactured in the U.S. (or its territories) or is conducted under an investigational new drug application or investigation of new drug exemption. 

The new statement must be included in all informed consent documents for applicable clinical trials initiated on or after March 7, 2012.  The consent rule will not be applied retroactively.  Therefore, clinical trials initiated before March 7, 2012 need not comply with new §50.25(c) nor will ongoing trials. 

For additional information, please see Guidance for Sponsors, Investigators, and Institutional Review Boards - Questions and Answers on Informed Consent Elements, 21 CFR §50.25(c) (Small Entity Compliance Guide) as published by the FDA in February 2012 and available as a PDF on the FDA website

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