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Article: Neil Constantine, Ph.D., University of Maryland School of Medicine, Baltimore, Nov. 17 (CBER).(Medical Devices)
- Article from:
- Warning Letter Bulletin
- Article date:
- January 1, 2005
CopyrightCOPYRIGHT 2005 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The agency conducted an inspection from July 12-21, 2004, in which FDA inspector Stephanie Shapley reviewed Constantine's conduct as a clinical investigator testing investigational devices in three studies: one involving a known HIV-1-positive population (Study 1); one involving a low-risk population (Study 2); and one involving a high-risk population (Study 3).
The agency determined that Constantine failed to obtain informed consent from 88 of 201 subjects enrolled in Study 3.
Constantine also failed to include one of the basic elements in the informed consent form used for all three studies. FDA said the consent forms approved by the University of ...