FDA EIR - Essex Institutional Review Board, Inc - March 21, 2011

A routine FDA inspection of Essex Institutional Review Board, Inc. (Lebanon, NJ) was conducted from March 14 to March 21, 2011, covering operations from 2009-2011. This inspection, conducted under regulatory framework CP 7348.809 and pertaining to 21 CFR 56 and 21 CFR 50, was prompted partly by the IRB's approval of a fictitious study involving a fabricated sponsor and clinical investigator. The inspection revealed significant deficiencies, including the IRB's failure to adequately determine and minimize risks to human subjects, and its inability to ascertain the acceptability of proposed research in accordance with regulations and professional standards. Specifically, Essex IRB approved a study without verifying the clinical investigator's medical license, failed to identify a previously withdrawn drug with known cardiovascular risks, and incorrectly categorized a Phase I 'first-in-man' study as presenting only minimal risk. Further issues involved insufficient detail in meeting minutes regarding risk determinations and controverted issues, and inadequate informed consent forms that omitted foreseeable risks. An FDA-483, detailing these inspectional observations, was issued to management, who indicated a written response would be forthcoming.