| Sumario: | This article focuses on the ethical considerations and institutional review board (IRB) oversight involved in using RECTIFIER, an AI-enabled clinical trial recruitment tool based on a large language model (LLM). RECTIFIER demonstrated high accuracy and efficiency in assessing trial eligibility compared to human staff and was developed and validated under IRB supervision before commercialization by AIwithCare. Key ethical elements addressed include reliability and validity, safety and accountability through a "human in the loop" approach, and privacy and security compliant with HIPAA standards. The authors emphasize the need for IRBs and human research protection programs (HRPPs) to adopt adaptive, evidence-seeking review processes that evolve alongside AI technologies, while cautioning against holding AI tools to standards that exceed those applied to human recruiters, a phenomenon termed "AI exceptionalism."
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