Xenograft recipients and the right to withdraw from a clinical trial

Pre-clinical xenotransplantation research using transgenic pigs has begun to show some promising results and could one day offer a scalable means of addressing the organ shortage. While it is a fundamental tenet of ethical human subject research that participants have a right to withdraw from research once enrolled, several scholars have argued that the right to withdraw from xenotransplant research should be suspended because of the public health risks posed by xenozoonotic transmission. Here, we present a comprehensive examination and critical evaluation of the claim that xenotransplant recipients should be required to waive their right to withdraw from lifelong bio-surveillance. We conclude that, if xenotransplantation requires participants to waive their right to withdraw, then clinical trials may not be justifiable given the ethical and legal obstacles involved with doing so. Consequently, if clinical trials are permitted with a right to withdraw, then they may pose a significant existential and public health risk.