Elena Salvaterra

This study analyzes the ethical and regulatory dilemmas of 3D bioprinting and bioartificial organs within the fields of engineering, medical physics, and transplant surgery. Using a qualitative approach, 19 stakeholders (transplant candidates and donors) were interviewed at the Cà Foncello Hospital (Treviso, Italy). The thematic analysis revealed the "Knowledge versus Unconditional Trust" paradox: low technical literacy regarding stem cells combined with absolute therapeutic faith in biomanufacturing. To resolve uncertainty concerning long-term graft maturation, a "responsible innovation" framework incorporating medical physics criteria is required. In the face of international regulatory ambiguity, a model based on Mill's sovereignty is proposed to provide physical certainties. This construct is operationalized as "Elastic Consent": a dynamic architecture of iterative verification, real-time physical monitoring, and continuous tracking of the implant's lifecycle.

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.

A shift is taking place in the field of regenerative medicine and transplantation. Recent advances in bioprinting have made available new products, like bio-artificial tissues and organs, that offer to the recipients personalized solutions, reducing surgery duration and fostering tissue regeneration. Though encouraging, these implants raise critical ethical issues that need to be considered carefully. The existing literature identifies critical ethical, legal and social issues such as the body digitalization, rejuvination, immortal life, ownership of artificial bioconstructs, intellectual property rights and social discriminations. and the feelings of the stakeholders about the fabrication of bio-artificial organs and their transplantation. However, few publications analyse the ethical problems of early-phase clinical trials and even less articles explore the opinions In light of this scenario, this research aims to explore the knowledge, opinions, attitudes and hopes of patients and donors towards the bioprinting and organ transplantation by eliciting the underlying ethical feeling. The findings of this study may help to revise the current ethical, legal and social issues related to regenerative surgery based on a bottom up approach by engaging patients and donors. Moreover, it may contribute to develop or review guidelines dedicated to bioprinting and regenerative transplantation.