Developing Engagement Protocols for Donor Family Members and Healthcare Staff During Research Involving the Recently Deceased

SUMMARY/ABSTRACT Research involving recently deceased humans physiologically maintained following declaration of death by neurologic criteria (“DNC research”) is the most promising method for advancing xenotransplantation, and has potential to become the optimal model for studying countless interventions that carry risks we cannot justify imposing on living human research participants. DNC research has also been used to test novel pharmaceuticals and medical devices, and is going to be used to test gene therapies. During recent DNC studies including one that lasted 8 weeks, our institution gained novel insights impossible to obtain from any other translational model about function, human immune response, and survival of xenogeneic organs. DNC research involves testing experimental interventions in “brain dead” humans. Although the person is deceased, the body and physiological functions are maintained through medical interventions delivered by bedside healthcare staff (such as nurses) with training and experience caring for living patients, raising a number of potential concerns related to the rights and well-being of family members who authorize DNC research (“DNC family”) and healthcare staff. There is known confusion about the definition of brain death, and healthcare staff and DNC families have concerns about zoonotic disease, questions about prioritization of clinical care versus research, and what constitutes respectful treatment of the body in DNC research. These issues could negatively impact attitudes toward DNC research and promote distrust of research, thereby limiting donor availability. No guidelines exist for engagement with DNC research stakeholders, and there is no consensus approach for how to obtain DNC research authorization from donor families. Our aims are to (1) understand experiences, attitudes, and perceptions of DNC family members and healthcare staff involved in DNC research at the bedside, (2) conduct a focused ethnography of healthcare staff participating in DNC research, and (3) to design new protocols to guide engagement with DNC family members and healthcare providers during the conduct of DNC research. DNC research could serve as the most effective translational bridge to an unlimited supply of organs to treat end stage organ failure and could also become the most effective model for research on countless other life- saving interventions. However, the rights and wellbeing of families and healthcare staff must be prioritized during DNC research. Protocols developed in this study will inform transplant programs, OPOs, and all other entities preparing to perform DNC research in the US on how to engage ethically with donor families and healthcare staff in this novel translational research. Project Number: 1R01HL179183-01 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Macey Levan | Institution: NEW YORK UNIVERSITY SCHOOL OF MEDICINE, NEW YORK, NY | Award Amount: $762,747 | Activity Code: R01 | Study Section: Special Emphasis Panel[ZRG1 SEIR-B (80)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R01HL17918301