Dr G Owen Schaefer1
1Yong Loo Lin School Of Medicine, National University Of Singapore
A framework originally developed by the WHO during the 2014 Ebola outbreak and adapted to the COVID-19 pandemic, Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is intended to facilitate the use of unproven but promising interventions when clinical trials are infeasible. MEURI is claimed not to be research since its primary aim is to benefit patients. However, in this paper I argue the explication of the ‘M’ of MEURI makes it (or an essential component of it) fall within the scope of research, and thus subject to prevailing standards of research ethics. Monitoring is not incidental to MEURI, but a crucial requirement of it, as the MEURI framework states clinical outcome data must be gathered and shared with the wider scientific community to improve knowledge surrounding the unproven intervention.
This is not a mere semantic distinction, but has crucial ethical implications not captured in existing MEURI guidance. Consent must be given (or waived) not only for the clinical intervention itself, but the research monitoring, use and sharing of the data. If individuals must agree to said research use of data in order to access the unproven intervention, then the intervention itself could also be considered within scope of a research protocol. Application of well-established research oversight systems such as IRB review is not merely advised, but essential. The COVID-19 pandemic has demonstrated that robust research (including observational studies) is quite feasible in emergencies, and there is no need to further blur the line between research and clinical practice.
Biography:
Owen Schaefer is an Assistant Professor at the Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore. He received his DPhil in Philosophy from Oxford University, and has completed fellowships at the National Institutes of Health’s Department of Bioethics and the Oxford Centre for Neuroethics. His primary interests lie in the ethics of developing novel biomedical technologies. He has written on big data, research ethics, gene editing, human enhancement, precision medicine, vaccine allocation, assisted reproduction and in vitro meat.