FDAnews Device Daily Bulletin

Informed Consent, Other Violations Trigger Warning Letters

Feb. 29, 2008

Clinical investigators in two device trials failed to obtain informed consent, according to separate FDA warning letters.

Mark Adams, who is listed as a neurosurgeon on the website of Michigan’s Covenant HealthCare, obtained a subject’s signature on an outdated informed consent form (ICF) for the study of the Prestige artificial cervical disc to treat symptomatic cervical disc disease, according to a warning letter issued Jan. 23 and posted to the FDA website earlier this month.

In the other warning letter, which was sent Jan. 28 and posted to the FDA’s website this month, Marin Kollef, a professor of medicine at the Washington University School of Medicine, was cited for failing to obtain signatures and dates from subjects or their legally authorized representatives on a number of ICFs before enrolling them in a device study. He obtained verbal consent from other subjects, had 19 subjects sign an ICF that lacked a required study flow sheet and allowed staff to get informed consent who were not authorized to do so.

Kollef said the study for which he was cited was an initial substudy. After the FDA informed him of the violations, Kollef said he had the staff go through a training process, and the FDA found no problems when it audited the subsequent main study.

Adams could not be reached for comment at press time. The warning letters can be accessed at www.fda.gov/foi/warning_letters/s6652c.htm (Adams) and www.fda.gov/foi/warning_letters/s6658c.htm (Kollef).