FDA WARNING_LETTER - Advanced Interventional Pain Ctr IRB - October 24, 2013

The FDA issued a Warning Letter to Dr. Pattanam Srinivasan, Head Official of Advanced Interventional Pain Center IRB, following an inspection from September 30 to October 24, 2013. The inspection revealed serious violations of 21 CFR Part 50 (Protection of Human Subjects) and Part 56 (Institutional Review Boards) concerning device investigations. Dr. Srinivasan was also noted as the sponsor and clinical investigator for the study "(b)(4)". Key violations included: 1) Failure to maintain adequate written procedures for IRB functions, such as initial and continuing review, changes in approved research, and reporting (21 CFR 56.115(a)(6)). 2) Failure to ensure informed consent documents (ICDs) contained all required information per 21 CFR 50.25, compromising subjects' ability to make informed decisions (21 CFR 56.109(b)). 3) Failure to prevent IRB members with conflicting interests from participating in project reviews, exemplified by the IRB Chairman voting on a study where he performed procedures (21 CFR 56.107(e)). 4) Failure to prepare and maintain adequate documentation of IRB activities, including original protocols and detailed meeting minutes (21 CFR 56.115(a)(1), (a)(2), (a)(4)). The IRB's November 11, 2013, response was deemed inadequate, lacking details on implementing new procedures, training, re-consenting patients, and ensuring future ICD compliance. New procedures were insufficiently detailed and did not address regulations like 21 CFR 56.108(a) and (b) or email voting for significant protocol changes. The FDA requires a teleconference within two weeks and documentation of corrective actions, recurrence prevention, and monitoring plans within 15 working days to avoid further regulatory action. These deficiencies compromise human subject protection and research data integrity.