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INVESTIGATOR IMPLANTED DEVICES WITHOUT CONSENT, FDA SAYS

February 28, 2007

A clinical investigator recently received an FDA warning letter for implanting his experimental devices in 175 subjects without the proper informed consent forms.

During inspections in September 2006, the FDA found that Mathias Fobi at the Center for Surgical Treatment of Obesity implanted devices in subjects before receiving approval and without consent forms, the Jan. 24 warning letter said.

Several subjects did not sign appropriate consent forms before Fobi implanted the devices, according to the letter, posted Jan. 30 to the FDA website. Some of the forms indicated consent to undergo surgery, but did not indicate the subjects would be participating in a clinical trial. Also, eight subjects signed a consent form that had not received institutional review board approval, the letter noted.

Fobi implanted the devices in subjects before receiving either conditional approval from the FDA or institutional review board approval, the letter said.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6213d.pdf ( http://www.fda.gov/foi/warning_letters/g6213d.pdf ).