FDA 483 - Alameda Health System IRB - October 10, 2019

An FDA inspection conducted at Alameda Health System IRB from October 7-10, 2019, identified a significant concern regarding the integrity of its Institutional Review Board (IRB) review process. The primary observation was that the IRB permitted a member with a conflicting interest to participate in both the initial and continuing review of a project. This issue was noted across multiple review dates between October 2017 and August 2019, indicating a recurring problem.

Further complicating this, the inspection found that while some IRB members abstained from votes, the meeting minutes lacked clarity. Specifically, it was not adequately documented whether members with identified conflicts of interest physically left the room during deliberations, or if their abstention simply reflected their conflict. This lack of clear documentation also extended to votes on project modifications beyond initial and continuing reviews.

Although the FDA 483 document itself does not cite a specific Code of Federal Regulations (CFR) section for this observation, it operates under the broader regulatory framework of the Federal Food, Drug, and Cosmetic Act, particularly Section 704(b), which mandates reporting of objectionable conditions. These observations highlight the need for Alameda Health System IRB to implement robust corrective actions. These actions should ensure strict adherence to conflict of interest policies, transparent documentation of member participation in reviews, and clear protocols for managing conflicted members during deliberations to safeguard the ethical oversight of human subject research.