Ethical challenges in RCTs of antemortem interventions
Randomized controlled trials of antemortem interventions in organ donation are required to ensure that such interventions are both safe and effectiveness. The design and conduct of RCTs of antemortem interventions raise difficult ethical issues, including informed consent from donor families and recipients, equipoise, protections for imminently dying patients, and protections for research bystanders, including donor families and recipients of non-target organs. Ethical guidance specific to RCTs of antemortem interventions in organ donation does not exist and is urgently needed.