FDA 483_RESPONSE - Agility Medical Research, Inc. - December 21, 2022

Agility Medical Research, Inc. underwent an FDA inspection from December 5 to December 21, 2022, led by Investigator Dr. Richard A. Lyght. The inspection identified significant issues related to informed consent procedures. Specifically, four out of 37 subjects were initially consented using a Spanish short form that lacked IRB approval and did not include essential elements of informed consent, such as risks and study procedures.

The regulatory framework requires that all consent forms, including short forms, be approved by an Institutional Review Board (IRB) to ensure compliance with ethical standards in human subject research. The primary violation was the use of an unapproved Spanish short form, which was not aligned with the IRB-approved English long form that served as the written summary.

In response, Agility Medical Research acknowledged the deficiencies and outlined corrective actions. These included revising the consent process to ensure compliance with IRB requirements and improving oversight to prevent future occurrences. The company also highlighted that the subjects involved were bilingual and had initially received and signed the full IRB-approved English long form. However, the Spanish form was necessary for neurocognitive testing preferences.

Immediate corrective actions were taken upon realizing the issue, including notifying relevant personnel and ceasing the incorrect use of the short form. The company is committed to implementing systems-based quality improvements to address these compliance issues and ensure adherence to regulatory standards in future research activities.