FDA EIR - Arrowsmith Eye Institute - October 07, 2003

The FDA conducted an inspection of Arrowsmith Eye Institute, led by Dr. Peter M. Arrowsmith, on October 6-7, 2003, focusing on a sponsored investigational study. This inspection, carried out under regulatory guidelines for clinical investigators and human subject protection, identified significant non-compliance concerning the conduct of clinical trials. Key violations included deficiencies in informed consent, where one subject signed an unapproved form, another signed months after their procedure, and at least one consent was not in easily understandable language. Furthermore, the original consent for one subject was mistakenly destroyed. Communication with the Institutional Review Board (IRB) was severely lacking; Dr. Arrowsmith failed to notify the IRB of adverse events, lens exchanges, patient withdrawals, or subjects lost to follow-up, and did not obtain IRB approval for protocol deviations like early implantation of a subject's fellow eye, even when sponsor-approved. Adverse events were reported to the sponsor years after their occurrence, and the sponsor commendably refused a request to backdate reports. The sponsor also offered incentives to staff and subjects without documented IRB approval. An FDA Form 483, Inspectional Observations, was issued to Dr. Arrowsmith, outlining these findings. The inspection underscores the critical need for strict adherence to informed consent procedures, comprehensive and timely reporting to the IRB, and diligent compliance with approved study protocols to ensure the safety and rights of research participants. The Center will further review the findings and communicate future requirements.