Research Ethics Consultation: Xenotransplantation

Abstract: One aspect of the question, “what does it mean to be human?” concerns whether humans are distinct from other animals. To the extent that xenotransplantation –transplantation of animal organs into humans—is possible, the separation of the species becomes less clear-cut. The ethical implications are complex and weighty. Xenotransplantation experimentation in humans also raises profoundly challenging questions about research ethics, which this panel will address.

Speaker #1 is a philosopher/clinical ethics consultant who will discuss questions related to the risks of xenozoonotic infection: Does it violate a research subject’s right to withdraw from research if they are required to submit to lifelong infectious disease surveillance? Should family members and close contacts of a subject be required to consent to ongoing surveillance? How should research-related infection risks to the public be addressed?

Speaker #2 is a transplant surgeon/PhD in health care ethics who will examine using healthy subjects for first-in-human kidney xenotransplantation trials. Bringing together the purpose of first-in-human trials (safety and tolerance) with the threshold for risk in other clinical trials, may be the most rational approach to avoid therapeutic misconception that using an alternative population of end stage renal disease patients with little or no hope of human allograft transplantation engenders.

Speaker #3 is a pediatrician/philosopher who has published 2 books on organ transplantation. The speaker will examine historical (Baby Fae) and current debates about whether pediatric heart xenotransplantation should be attempted when adult research is still preliminary, and will analyze its consistency with Federal Regulations for research involving children.