FDA EIR - Emerson Hospital Human Rights Committee - July 24, 2014

A routine FDA inspection of the Emerson Hospital Human Rights Committee (HRC), acting as an Institutional Review Board (IRB), was conducted from July 8 to July 24, 2014. The inspection, carried out under FDA's bioresearch monitoring compliance program, uncovered multiple deficiencies in the IRB's operations concerning federal regulations for human subject protection. Key violations included the failure to maintain a complete and accurate list of IRB members, a lack of quorum at convened meetings for research reviews, and inadequate detail in meeting minutes regarding attendance, votes, and discussions—a persistent issue identified in prior inspections. Additionally, the IRB permitted a member with a conflict of interest to participate in reviews, did not adequately inform members of expedited approvals, and failed to follow its own procedures for reporting actions to investigators and the institution. Management at Emerson Hospital acknowledged these findings and indicated their intent to cease reviewing FDA-regulated research, stating they wish to transfer oversight of all such studies to an external IRB by November 2014. They committed to updating their IRB registration following this transfer and were asked to provide a formal written response to the FDA's observations.