Biomedical Research Inst. of America – FDA EIR, Oct 25, 2010

This FDA inspection of Biomedical Research Institute of America (BioMed IRB), conducted from September 22 to October 25, 2010, identified significant deviations from regulatory requirements governing Institutional Review Boards. The inspection, requested by CBER's Bioresearch Monitoring Branch under CP: 7348.809, aimed for a routine review of the IRB and specific studies.

Key violations, detailed on an FDA 483 form, included the IRB's failure to adhere to its own written procedures. Specifically, BioMed IRB established an unapproved process for planned protocol deviations in a study, affecting human subject rights and safety, without prior IRB approval as mandated by their standard operating procedures (SOPs). Meeting minutes were found to be inaccurate and incomplete, lacking clear documentation of discussions and votes, and containing duplicated information that obscured the decision-making process. The IRB also failed to consistently include clinical investigators in essential communications regarding study approvals and conditions, and did not verify that conditions for protocol approval were met. Furthermore, comprehensive study-related correspondence was not readily available for review, requiring repeated requests from the inspectors.

The inspection also noted BioMed IRB's apparent non-adherence to its site audit procedures and inconsistencies in adverse event reporting. While the IRB's audit concluded no major issues, a large number of serious adverse event reports from the audited site were subsequently received, contradicting prior assurances. Previous inspection findings from 2009 regarding procedural non-compliance had seen documented corrections, yet new systemic issues emerged.

BioMed IRB representatives disputed the accuracy of the observations and indicated they would provide a formal written response to the FDA outlining their corrective actions. This response is critical to address the identified compliance gaps and ensure the protection of human subjects in research.