FDA 483 - Mass General Brigham Inc. IRB - May 23, 2017

An FDA inspection of Partners Human Research Committees in Somerville, MA, revealed a significant issue regarding informed consent. The Institutional Review Board (IRB) failed to ensure that all necessary elements of informed consent were included in information provided to subjects. Specifically, changes to an Informed Consent Form for a protocol were not properly incorporated, leading to subjects re-signing an incomplete form.