FDA EIR - M.D. Anderson Cancer Center - November 12, 2004

An FDA inspection of M.D. Anderson Cancer Center's Institutional Review Board (IRB) took place from October 19 to November 2, 2004. Conducted under the regulatory framework for Institutional Review Boards (CP 7348.809), the inspection aimed to assess compliance with applicable regulations and identified several significant issues. Main violations included the failure of informed consent documents (ICDs) to accurately describe all required elements, such as comprehensive risks associated with an experimental drug (e.g., immunogenic potential, risks from a biohazardous preparation, and imaging scans) and appropriate alternative procedures. Some ICDs also contained inaccurate statements, including false claims of FDA authorization for a drug. The IRB was cited for not adequately minimizing risks to subjects by approving a study involving a biohazardous product without ensuring sufficient viral and disease transmission testing. Additionally, the inspection found inadequate continuing review processes, where the IRB approved a report incorrectly indicating subject enrollment in an unactivated study. Documentation was also lacking to demonstrate the IRB's adequate justification of study risks against anticipated benefits for another protocol. An FDA 483 form detailing these observations was issued. In response, M.D. Anderson Cancer Center management affirmed their commitment to patient safety and corrective actions, and the IRB members stated they would revise their ICD review policy. Actions required include rectifying these deficiencies, ensuring accurate risk assessment and disclosure, improving continuing review, and enhancing documentation of risk-benefit analyses.