Embryo models and the regulatory void: ethical imperatives before legal action.

Abstract

Advances in stem cell research have enabled the creation of embryo models that challenge existing definitions and regulatory boundaries in embryo research. The scientific community has struggled to establish a coherent nomenclature for these models, leading to confusion and sensationalism about their nature and applications. Moreover, recent publications by the Nuffield Council on Bioethics and the Ethics Committee of the European Society of Human Reproduction and Embryology have argued that embryonic models derived from stem cells are ineligible to be included in the definition of an embryo. However, some countries had already enacted legislation addressing the classification of certain models derived from stem cells as embryos prior to the issuance of these guidelines. This discrepancy engenders considerable tension among the scientific viewpoints of the countries safeguarded by these laws, with suggestions emerging from authoritative agencies. This research seeks to recognise the regulatory and ethical void created by inconsistent definitions of embryo-like entities and to advocate for a framework fostering interdisciplinary agreement in response to recent advancements. Alternatively, we aim to promote a bioethics that not only supports legislative decisions but also guarantees their validation before their implementation. We argue that without a unified interdisciplinary framework, legal structures may become fragmented, jeopardising both research integrity and public trust.