Donor intervention trials test treatments aimed at preserving organs in transplantation. Many such trials apply treatments to deceased organ donors before transplantation. Drawing on a recent National Academy of Medicine report, this review describes how such studies implicate the welfare of at least four different types of individuals who would not be considered human subjects under current regulations. I close by describing why protections of some sort ought to be extended to each of these four types of research bystanders.
Committee on Issues in Organ Donor Intervention Research. Opportunities for organ donor intervention research: saving lives by improving the quality and quantity of organs for transplantation. In: ChildressJDomnitzSLivermanC (eds) Consensus Study Report of the National Academies of Sciences Engineering and Medicine. Washington, DC: National Academies Press, 2017.
2.
NiemannCUFeinerJSwainS, et al. Therapeutic hypothermia in deceased organ donors and kidney-graft function. N Engl J Med2015; 373: 405–414.
3.
ShahSKKasperKMillerFG. A narrative review of the empirical evidence on public attitudes on brain death and vital organ transplantation: the need for better data to inform policy. J Med Ethics2015; 41(4): 291–296.
4.
ReyMMWareLBMatthayMA, et al. Informed consent in research to improve the number and quality of deceased donor organs. Crit Care Med2011; 39(2): 280–283.
5.
WareLBLandeckMKoyamaT, et al. A randomized trial of the effects of nebulized albuterol on pulmonary edema in brain-dead organ donors. Am J Transplant2014; 14(3): 621–628.
