Biomedical Research Institute of America d/b/a BioMed IRB – FDA Warning Letter, Aug 19, 2011

The FDA issued a Warning Letter to BioMed IRB following inspections from September-October 2010 and August 2011, which assessed the IRB's procedures for human subject protection under 21 CFR Parts 50 and 56. The inspections revealed significant violations in the IRB's operations. Deficiencies included failure to fulfill membership requirements (21 CFR § 56.107), specifically lacking professional competence for reviewing certain research activities and allowing non-members to vote. The IRB also failed to prepare, maintain, and follow adequate written procedures for research review (21 CFR §§ 56.108(a), 56.115(a)(6)), as its SOPs did not require majority approval for research and pertinent study documentation was not consistently distributed to all voting members. Furthermore, meeting minutes were insufficient (21 CFR § 56.115(a)(2)), showing conflicting attendance, inadequate recording of actions and votes, and lacking summaries of controverted issues. Due to these systemic failures, FDA has no assurance of adequate human subject protection. Effective immediately, FDA will withhold approval of all new studies and prohibit new subject enrollment in ongoing studies approved by BioMed IRB, per 21 CFR §§ 56.120(b)(1) and (2). The IRB must respond within fifteen business days with specific corrective actions, documentation, and projected completion dates, and notify affected sponsors. Failure to comply may result in further administrative actions, including study termination and IRB disqualification.