Navigating the moral uncertainty: autonomy and consent at the edge of bioartificial organ transplantation

Objective This study proposes a reading of the ethical and regulatory vagueness surrounding bioartificial organ transplantation as a consequence of the disruptive nature of this technology and it suggests to navigate this moral uncertainty through a Millian re-interpetation of principle of autonomy. Design This study employs Robert Baker’s theory of ‘morally disruptive technologies’ to interpret the current lack of international regulatory harmonization. It provides a comparative overview of existing frameworks, including the EU’s Medical Device Regulation, the US FDA’s combination product approach, and the 2026 UAE Federal Decree-Law. It then applies a Millian philosophical lens to evaluate patient sovereignty in the context of experimental transplantation of bio-artificial organs. Results This analysis shows a significant gap between rapid technological strides (e.g., bioartificial kidneys and bladders) and fragmented legal oversight. Bioartificial transplantation qualifies as a disruptive technology that invalidates traditional moral maps. The study identifies that while international guidelines (Oviedo Convention, Declaration of Helsinki) mitigate vagueness, they do not resolve the ‘moral nebula’ of lab-created organs. Conclusions A re-interpretation of Millian autonomy—defined as individual sovereignty over one’s body and the ‘knowledge of one’s own ignorance’—serves as a “moral compass”. This framework justifies the patient’s right to engage in ‘experiments in living’ despite clinical uncertainty, provided the ‘harm principle’ (e.g., zoonosis risks) is respected. The study proposes a model of ‘elastic consent’ that prioritizes the declaration of uncertainty, offering a transition toward a new social and ethical order in regenerative surgery.