FDA 483 - Legacy Health IRB - December 17, 2021

During an inspection conducted from December 13-17, 2021, the FDA issued a Form 483 to Legacy Health IRB, identifying significant deficiencies in its operations as an Institutional Review Board. The inspection highlighted four key observations related to regulatory compliance for human subject protection.

Firstly, the informed consent document for a specific study was found deficient, lacking a complete description of reasonably foreseeable risks and discomforts to subjects. Additionally, the consent form presented inconsistent information regarding a subject's right to withdraw from a study, simultaneously stating they could withdraw without reason while also requiring them to provide reasons and complete a withdrawal form.

Secondly, Legacy Health IRB failed to update its registration information with the FDA concerning changes in its chairperson within the required 90-day timeframe. Furthermore, the registration contained inaccurate and conflicting details about a listed chairperson, including gender and affiliation.

Finally, the IRB was observed not adhering to its own written standard operating procedures for the initial and continuing review of research studies. Specifically, the board responsible for FDA-regulated research did not meet the minimum member count stipulated in their procedures, and study approvals were being signed by the IRB Administrator instead of the designated Institutional Official. Legacy Health IRB is expected to address these observations with appropriate corrective actions.