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Compliance In Focus
Posted by John Lehmann on Fri, Feb 17, 2012

“21 CFR 50.25(c): New Requirement for Consent Forms Being Enforced”

It’s official! According to the new guidance released on the FDA’s website all applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include this specific statement that refers to the trial’s description on http://www.clinicaltrials.gov:

“A description of this clinical trial will be available on www.ClinicalTrials.gov  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.”

This statement must be included, and worded precisely as written above for all clinical trials that fall under the new requirement. MassDevice authored an article about the new FDA informed consent rules. The article points out that “the onus is on sponsors and investigators to determine whether their clinical trials must comply with the new rules.”

To help understand new requirements the FDA has issued a guidance, “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” Within the guidance are many helpful answers to various questions, including:

  • What is the exact statement required to be included in informed consent documents?
  • Why is this new statement necessary?
  • What clinical trials are specifically excluded from the definition of “applicable clinical trials?”
  • When must sponsors and investigators begin including the new statement in informed consent documents?
  • What are the responsibilities of an IRB under the new rule?

Read the guidance as well as the article, and let us know your thoughts on the new requirement for informed consent documents. IMARC released a blog not too long ago on the pros & cons of a shortened informed consent form. Overall, how do you think this will affect the informed consent process?

Topics: Informed Consent, Medical Device CRO, 21 CFR § 50.25(c), MassDevice

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