Ethical Challenges of New Technologies and Insights from Research Ethics Experts on Oversight of AI in Health, Extended Reality, Gene Editing and Biobanking

Abstract

Abstract Research on emerging technologies such as AI-driven health interventions, extended reality (XR) systems, biobanks, and genome editing poses novel ethical challenges that traditional ethics governance models struggle to address. This article explores various models of research ethics governance within the European Union (EU) context, starting from traditional one-time research ethics committee (REC) reviews, REC review with post-approval monitoring, as well as alternative models such as ethics self-assessment, and ethics-by-design approaches. Based on literature analysis and a survey of European research ethics experts, the study identifies prevalent models of research ethics oversight, research ethics expert perceptions of their sufficiency, and challenges such as insufficient technical and ethics expertise, lack of specific guidelines, and unclear boundaries of REC responsibilities. Findings also indicate that traditional REC reviews remain dominant but have limitations in effectively managing rapidly evolving technologies. Research ethics experts highlighted the feasibility of continuous oversight mechanisms to better integrate ethical reflection throughout the research lifecycle. The article concludes by recommending a shift towards proportional, risk-based oversight, development of clearer, technology-specific guidelines, enhanced REC training, and improved harmonization across EU ethics governance systems to address current gaps.

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