Professional Oversight of Emergency-Use Interventions and Monitoring Systems: Ethical Guidance From the Singapore Experience of COVID-19

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 (POEIMS) 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.

Automated summary

The COVID-19 pandemic has brought about high levels of uncertainty and limited effective treatment options. Providing drug products outside of research settings has been a controversial topic. This article proposes the use of the Professional Oversight of Emergency-Use Interventions and Monitoring System (POEIMS) as an alternative pathway, based on guidance developed in Singapore. The authors argue for the moral duty of physicians to record outcomes data and institutions to establish monitoring systems for reporting safety and effectiveness information.