Abstract

Abstract Study question What are the key ethical, social and regulatory issues raised by artificial intelligence technologies (AI) for embryo selection, and how might these be best managed? Summary answer Key issues with AI for embryo selection include deskilling, transparency, accountability, and fairness. These require attention to improve psychosocial and clinical outcomes in ART. What is known already Artificial intelligence (AI) technologies play a growing role in the assisted reproductive technology (ART) sector. Machine learning holds enormous promise for improving the selection of human embryos for transfer after IVF. Time-lapse imaging in conjunction with machine learning has the potential to standardise and automate embryo selection, improving clinical outcomes. Promising results have recently been published, and AI tools have reached the market. However, ethical and regulatory analysis has not kept pace with the technology. There has been negligible research on the ethical, social, and regulatory issues raised by the use of machine learning methods for embryo selection. Study design, size, duration A terrain-mapping review of the academic literature was performed to identify the key social, ethical and regulatory issues raised by AI for embryo selection. This is part of a multi-method study, collecting qualitative and quantitative data alongside ethical and regulatory analysis.The study is expected to take 1 year. Participants/materials, setting, methods A systematic review of the extant literature on the ethical, social, and regulatory issues raised by machine learning for embryo selection, combined with a narrative review of the broader literature on the use of AI in healthcare was undertaken. This review of ethical and regulatory issues will ultimately combine with data from semi-structured interviews and an online survey of ART patients and practitioners, including fertility specialists and embryologists, and ART regulators in Australia. Main results and the role of chance This paper reports on ethical and regulatory analysis of key issues that emerge from the use of AI for embryo selection. The use of AI in healthcare generally has raised serious concerns about deskilling and ‘dehumanization’(as roles traditionally performed by humans are displaced by technology), transparency, accountability, and fairness. This paper examines these issues in the ART context, to begin to develop guidance on how to best implement this technology in ways that balances the interests of all stakeholders and is consistent with maintaining public trust in the field of ART. Limitations, reasons for caution It is anticipated that much of the analysis of the social, ethical and regulatory issues will be generalisable internationally. However, the study prioritises one context - that of Australia. Some features of the Australian context may limit generalisability. Wider implications of the findings There is a need to address the ethical, social and regulatory issues that arise with the emergence of innovative technologies within ART to maintain public trust and ensure that psychosocial and clinical outcomes are improved. Further data collection on stakeholder views of machine learning for embryo selection will be required. Trial registration number Not applicable

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