Ethical and Policy Guidance for Translational Xenotransplantation Clinical Trials
Principal Investigators: Karen J. Maschke, PhD, The Hastings Center
Michael K. Gusmano, PhD, Lehigh University and The Hastings Center
Elisa J. Gordon, PhD, Northwestern University
Co-Investigator: Joseph Leventhal, MD, Northwestern University
Funder: National Center for Advancing Translational Sciences of the National Institutes of Health
Xenotransplantation is a novel experimental treatment that involves transplanting organs from nonhuman animals into humans to reduce the organ shortage—a public health problem. Most guidance documents addressing the ethical and policy challenges for xenotransplantation are limited because they are 10-to-20 years old, do not reflect changes in the science of xenotransplantation, do not account for stakeholder concerns, and do not consider the impact on policy changes to organ allocation. A research team of bioethics leaders at The Hastings Center, Lehigh University, and Northwestern University will conduct a four-year study to identify appropriate ethical and policy guidance for translational xenotransplantation kidney clinical trials—studies that connect basic research with clinical practice. With input from an advisory committee comprised of translational scientists, transplant clinicians, transplant policy experts, and human subjects research experts, the research team will develop up-to-date ethics and policy recommendations and decision aids for transplant candidates, transplant clinicians, and institutional review boards that will review xenotransplantation clinical trial protocols. The innovative and timely decision aids will contain generalizable ethical principles for human subjects research protections and policy considerations regarding organ allocation that will apply to xenotransplantation clinical trials involving other organs.