FDA Makes Changes To Informed Consent Requirements for Medical Device Trials

This past spring, medical device companies – and all other organizations participating in clinical trials – became subject to a new Final Rule regarding informed consent.  Specifically, the FDA implemented changes to existing informed consent regulations that now require the submission of clinical trial descriptions to the public ClinicalTrials.gov databank.  Trial participants must be informed of this fact by way of modified informed consent forms.

Some medical device companies may have initially passed over the FDA announcement as it was described as being applicable specifically to drug trials as described in the Food and Drug Administration Amendments Act 801(b)(3)(a).  However, the FDA has stated that the Final Rule, which went into effect March 12, 2011, applies to both medical device trials and clinical drug trials, with only a few exceptions.  The specific regulation can be found in 21 C.F.R. Part 50.25.

What does this mean for medical device companies currently in the process of organizing a clinical trial?  At the outset, it means that all informed consent forms must include the following text, supplied by the FDA:

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

Trials which are already underway will not be required to re-consent participants in order to incorporate the modified forms.

The law, which comes with a one-year grace period for implementation, assigns the responsibility for collecting informed consent to a trial’s investigator.  However, medical device companies should take note that once the forms have been gathered, it is usually necessary for the trial’s sponsor to take the initiative in posting the trial description information to ClinicalTrials.gov using the Protocol Registration System (PRS).  Moving forward, this simple added step should not be overlooked by medical device manufacturers engaged in clinical trial research.

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adapted and published with permission from MDCI

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