New England IRB – FDA EIR, Jul 14, 2016

An FDA inspection of New England IRB (NEIRB) was conducted from July 13-14, 2016, under the Bioresearch Monitoring Compliance Program 7348.809, at the request of the Center for Drug Evaluation and Research (CDER). The inspection reviewed NEIRB's adherence to FDA regulatory requirements, including procedures for studies involving children and adolescents. The review focused on three specific studies, examining IRB correspondence, research applications, continuing review, policies, rosters, meeting minutes, and Informed Consent Forms. During the inspection, NEIRB demonstrated appropriate procedures for reviewing protocols, especially regarding the need for an Investigational New Drug (IND) application when efficacy claims were made, as observed with study IRB #16-085. The IRB also correctly applied Subpart D requirements for studies involving minors. A discussion point was raised regarding the attribution of sponsor response letters within their electronic system, although email trails confirmed sender and date. Crucially, no FDA Form 483 Inspectional Observations were issued, indicating the absence of significant regulatory violations. Consequently, no formal corrective or required actions were mandated by the FDA following this inspection.