New informed consent requirements for some medical device clinical trials in the US will go into effect March 7, 2012.
The rules will require some clinical trial sponsors and investigators to include statements in their Informed Consent documents that clinical trial data will be entered into a database available via the website www.clinicaltrials.gov. Applicable clinical trials falling under the scope of the new rule include controlled intervention studies of device subject to FDA regulation, studies involving devices manufactured in the US, or studies conducted under Investigational Device Exemptions (IDE).
The onus is on sponsors and investigators to determine whether their clinical trials must comply with the new rules. Applicable clinical trials initiated on or after March 7, 2012 must comply with these requirements.
According to 21 CFR 50.25(c), Informed Consent documents for clinical trials falling under the new rule must include the following statement verbatim:
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 Web site will include a summary of the results. You can search this Web site at any time.
Medical device clinical trials specifically excluded from the new Informed Consent rules include small feasibility trials as well as trials for prototype devices with primary measures of feasibility.
