Trinity Hospital IRB # 1 – FDA 483, Feb 22, 2018

An FDA inspection conducted on October 29-30, 2014, at Quorum Review IRB in Seattle, WA, identified significant concerns regarding the Institutional Review Board's (IRB) compliance with regulatory standards. The primary issues observed relate to the IRB's review processes for research protocols and the conduct of its convened meetings. Specifically, the inspection revealed that the IRB did not adequately review all research activities governed by regulations. Instead of comprehensive review, IRB members primarily reviewed summaries of protocols provided before meetings. Full protocols were submitted by investigators but only one copy was available to the IRB, with only a summary distributed to each member, and no specific member was assigned for a full protocol review. This practice raises questions about the thoroughness of ethical and scientific oversight for human subject research. Furthermore, the inspection noted instances where the IRB failed to convene meetings with a proper quorum, as required for reviews beyond expedited procedures. Multiple meetings and votes on clinical research were conducted without a majority of members present, or without the required nonscientific member. Examples cited included meetings on August 6, 2014, September 23, 2014, April 1, 2015, October 8, 2015, and June 21, 2016. These findings indicate a systemic breakdown in adhering to established regulatory frameworks for IRB operations, particularly concerning the review of human subject protection. The identified observations require Quorum Review IRB to implement corrective actions to ensure full compliance with FDA regulations governing IRBs. The company is expected to address these deficiencies by revising its protocol review procedures and ensuring proper quorum at all convened meetings to uphold the integrity of research oversight.