483
Alameda Health System IRBAlameda Health System IRB – FDA 483, Oct 10, 2019
Record Details
An FDA inspection of Alameda Health System IRB in Oakland, CA, identified a significant issue regarding conflict of interest. The IRB allowed a member with a conflicting interest to participate in the review of a project, and meeting minutes lacked clarity on the handling of abstentions related to conflicts. This indicates a lapse in ensuring unbiased review processes.
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ID · c1c9bb25-e6a8-48a4-93a2-b7230bf0b1be
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