A patient-centered perspective on human subjects protections for deceased donor organ intervention research

Because of the shortage of organs available for transplantation, research is needed to increase the number and quality of organs available for transplantation (e.g., by cooling organs). However, it is possible that some of this experimentation might unintentionally harm the organs. Such research has been controversial because organ recipients are not informed of such research. This project asks whether and how physicians should explain to patients on the transplant waiting list that an organ being offered has been exposed to experimental interventions. National transplantation policy currently is silent on this question. Because organs must be procured and transported quickly, there is limited time for patients to learn about the offered organ and agree to transplantation. This time constraint restricts the recipient’s autonomy to decide whether to accept or decline an organ exposed to experimental interventions. This project will study how patients on the transplantation waiting list want to receive information about interventions on offered organs and whether new approaches are needed for consent before such organs are transplanted. The findings will inform national policies that try to improve organ preservation and access to transplantation, while also protecting patients’ ability to understand benefits and risks of a transplant and maintaining public trust in a fair and efficient organ allocation system.