FDA 483 - Jackson-Madison County General Hospital IRB - November 26, 2019

The FDA inspected Jackson-Madison County General Hospital IRB from November 18 to November 26, 2019, identifying several critical deficiencies in its operations. The primary violations centered on the IRB's oversight of human subject research, particularly studies involving children, and its administrative processes.

Specifically, the IRB failed to adequately document its determination that pediatric research complied with 21 CFR 50 Subpart D, including assessments of risk/benefit, assent, and parental permission. There was also a failure to follow written procedures for promptly reporting serious noncompliance or study suspensions, such as a sponsor-initiated enrollment halt due to informed consent issues, to both institutional officials and the FDA.

Further observations included the IRB's failure to conduct annual continuing review of research within the required timeframe and a lack of proper maintenance of all reviewed research proposals and sample consent documents. Additionally, the IRB's membership lacked diversity in race and cultural backgrounds, which is essential for comprehensive review and safeguarding human subjects. The hospital is expected to address these observations by implementing corrective actions and submitting a response to the FDA.