FDA EIR - Texas Applied Biotechnology Research Review Committee - April 25, 2012

An FDA inspection of Texas Applied Biomedical Services (TABS), an independent Institutional Review Board (IRB), was conducted from April 16 to April 25, 2012. The inspection, guided by CPGM 7348.809 and focused on adherence to 21 CFR 50 and 56, aimed to assess TABS's operations. This followed a previous 2007 inspection that also identified deficiencies. The current inspection resulted in 11 significant observations documented on a Form FDA-483. Key issues included conflicts of interest among IRB members participating in study reviews, and a failure to ensure risks to human subjects were minimized. TABS was cited for inadequate written procedures and insufficient detail in meeting minutes, the latter being a repeat observation. Additionally, the IRB failed to ensure proper provisions for soliciting assent from children in clinical studies. Multiple violations related to Informed Consent Forms (ICFs) were identified, such as the absence of reasonably foreseeable risks, clear descriptions of procedures, expected benefits, alternative treatments, and the approximate number of subjects. A repeat observation also noted the IRB's failure to prepare and maintain an adequate list of its members. The inspection further raised concerns regarding the IRB members' lack of sufficient medical background for reviewing significant risk studies and the absence of a formal training program. The President/Chairperson was informed that the FDA-483 is not a final agency decision, and FDA reserves the right to pursue various enforcement options, including warning letters and potential study limitations, emphasizing the seriousness of the findings.