FDA EIR - Medicine Invention Design Incorporation IRB - March 27, 2018

An FDA inspection of Medicine Invention Design Incorporation (MIDI) IRB, located in Rockville, MD, was conducted from March 20 to March 27, 2018. This "for-cause" inspection, carried out under regulatory guidance for Institutional Review Boards (IRBs), uncovered several significant violations of 21 CFR 56 concerning human subject protection. The main issues cited in an FDA-483 included: 1) A complete lack of written procedures for core IRB operations, such as initial and continuing review, reporting mechanisms, and managing research changes (21CFR56.108(a) and (b)). 2) The IRB Chair, Dr. Han Xu, also acting as a sponsor/investigator, improperly participated and voted in reviews of his own projects, demonstrating a conflict of interest (21CFR56.107(e)). 3) Failure to prepare and maintain detailed minutes of IRB meetings, lacking records of attendance, actions, voting, and discussion summaries (21 CFR 56.115(a)(2)). 4) The IRB did not include a single non-affiliated member, as several members had direct familial or property ownership ties to Dr. Xu or the IRB's operating location (21CFR56.107(d)).

Management, specifically Dr. Xu, acknowledged the observations and committed to corrective actions. He was instructed to submit a comprehensive written response detailing proposed corrections and timelines to the FDA's Baltimore District Office by April 17, 2018. Dr. Xu also indicated plans to establish proper procedures, address the conflict of interest in voting, and relocate the IRB to a dedicated business site to resolve the affiliation issue.