High degrees of uncertainty and a lack of effective therapeutic treatments have characterized the COVID-19 pandemic and the provision of drug products outside research settings has been controversial. International guidelines for providing patients with experimental interventions to treat infectious diseases outside of clinical trials exist but it is unclear if or how they should apply in settings where clinical trials and research are strongly regulated. We propose the Professional Oversight of Emergency-Use Interventions and Monitoring System as an alternative pathway based (...) on guidance developed for the ethical provision of experimental interventions to treat COVID-19 in Singapore. We support our proposal with justifications that establish moral duties for physicians to record outcomes data and for institutions to establish monitoring systems for reporting information on safety and effectiveness to the relevant authorities. Institutions also have a duty to support generation of evidence for what constitutes good clinical practice and so should ensure the unproven intervention is made the subject of research studies that can contribute to generalizable knowledge as soon as practical and that physicians remain committed to supporting learning health systems. We outline key differences between POEIMS and other pathways for the provision of experimental interventions in public health emergencies. (shrink)

This case report illustrates the ethical issues involved in paediatric liver transplantation, especially in terms of assessing recipient suitability and the role of parents as donors. Ms. X was a child with advanced chronic liver disease who undergone an elective living donor liver transplant with her father as the donor. Post-operatively, she was in a critically ill state as a result of acute liver graft failure with resultant multi-organ dysfunction. A re-transplant was done at 36 hours after the first one, (...) this time with her mother as the donor. She responded well to the transplant, however by post-operative day 8, it was evident that she had features of severe brain stem dysfunction and brain death was subsequently certified. The ethical issues that arise from this case, including the need for careful assessment of recipient suitability for a transplant and the specific considerations of using parents as organ donors, are discussed. (shrink)