FDA EIR - Christian Hospital IRB - December 02, 2011

An FDA inspection of Christian Hospital Northeast-Northwest Institutional Review Board (IRB) was conducted from November 29 to December 2, 2011, focusing on compliance with regulations governing human subject protection. The inspection revealed four significant deficiencies, many of which were repeat violations from previous inspections in 1998 and 2003.Key issues identified included the IRB's failure to consistently follow its own written procedures for the initial and continuing review of research studies. Specifically, there were discrepancies in meeting attendance records, lack of documentation for protocol reviews by designated members, and instances where both a member and their alternate voted.Furthermore, the IRB's meeting minutes were found to be insufficient, lacking crucial details such as complete attendance records, precise voting results (for, against, abstaining), and summaries of discussions on controverted issues. This deficiency made it impossible to determine if members with conflicts of interest recused themselves from deliberations or voting. The IRB also failed to maintain comprehensive membership lists, which lacked essential details like members' representative capacities and institutional relationships. A significant concern was the participation and voting of individuals in IRB meetings who were not officially listed as members, thereby affecting quorum validity.These observations were documented on a four-item FDA Form 483 issued to President Ronald B. McMullen. The hospital was advised to respond to these observations in writing within 15 days, outlining corrective actions to address the identified non-compliance with the Food, Drug, and Cosmetic Act and associated regulations.