Defining an appropriate ethical, social and regulatory framework for clinical xenotransplantation

The complex and global health issues surrounding xenotransplantation require all regulatory aspects to be thought of within a coherent framework. This article reviews recent literature on normative issues of xenotransplantation, giving particular attention to contributions focusing on the relationships among ethical, legal and social factors within the context of global changes and challenges.

Although the main regulatory issues (i.e. informed consent, criteria for patient enrollment in clinical trials, the rights and obligations of third parties, the ethical management of safety measures, and use of animals) remain central to the xenotransplantation literature, new ways of addressing these topics and relatively new regulatory issues are emerging.

Inadequacies or weaknesses in national and international regulation of xenotransplantation interact and affect each other in terms of both ethics and safety. Confronted with the worldwide scale of research, the main focus of regulatory issues in xenotransplantation is shifting toward the multifaceted issues of locality and globality.