Best foot forward: now is the time for Canadian ethical guidance on prospective interventional trials of antemortem interventions in organ donation

Excerpt

Antemortem interventions are widely performed on living patients who are candidates for controlled organ donation after circulatory determination of death (cDCDD).¹ Antemortem interventions encompass practices such as the administration of medications, donor management protocols, and the use of nontherapeutic medical devices, and seek to improve organ viability and subsequent transplant outcomes for organ recipients.² Nevertheless, evidence of the safety and effectiveness of many antemortem interventions is lacking.^3,4 As the proportion of cDCDD donors increases in Canada, prospective interventional trials are needed to ensure evidence-based practice. Yet, because such studies require the participation of imminently dying donors, interventional trials of antemortem interventions pose ethical challenges eclipsing even those faced in the research with neurologically deceased (NDD) donors currently getting underway in Canada.⁵ Left unaddressed, these challenges will impede rigorous evaluation of antemortem interventions.⁶ Because interventional research with NDD and cDCDD donors have several commonalities, existing guidance governing NDD research will prove useful. Nonetheless, crucial differences between these areas of research demand dedicated guidance for interventional trials of antemortem interventions. An ethical framework for the design and conduct of such research should be developed now—before the science gets underway. …