Tamiko Eto (Stanford U) and Heather Miller (Independent Consultant) have posted “Beyond Belmont: Convening a National Initiative to Update U.S. Research Ethics Principles for the Age of AI” on SSRN. Here is the abstract:
The Belmont Report’s principles have defined U.S. research ethics for decades. However, the rapid evolution of data-driven and AI research has exposed critical gaps that these principles cannot address (Lin & Zhicheng, 2024). While the foundational values outlined in the Belmont Report (respect for persons, beneficence, and justice) remain, they do not guide today’s research ethics or AI research risks, especially with regard to “human data subjects” whose data powers AI systems even when they are not traditional research participants. This paper presents empirical research into IRB professional experiences with AI research oversight and a proposed national initiative to address oversight gaps. Through qualitative case study interviews with Institutional Review Board (IRB)/Human Research Protection Program (HRPP) professionals, we document the specific challenges these regulatory bodies face when reviewing AI research protocols, their familiarity with the application of existing ethical frameworks, and their perspectives on updating foundational principles. Data collection is currently underway. Preliminary findings will ground our proposal for a public-engagement initiative, provisionally termed “Belmont 2.0,” which we are convening with support from the Center for AI & Digital Policy (CAIDP). Full analysis will be presented at the International Association for Safe & Ethical AI (IASEA) conference in February 2026. We address this urgent need through a coordinated, multi-stakeholder effort to update U.S. research ethics principles to meet the unprecedented challenges presented by the digital age. We are seeking organizational partners to co-lead this work. What emerges could become a defining ethical foundation for 21st-century research globally, not only in the United States.