<- Home <- Arhive <- Vol. 28, Issue 2, June 2020



Rom J Leg Med28(2)101-108(2020)
DOI:10.4323/rjlm.2020.101
© Romanian Society of Legal Medicine


ETHICAL ISSUES AND ARGUMENTS FOR A LEARNING HEALTH CARE SYSTEM IN THE COVID-19 PANDEMIC

I. Diac, L. Udriștioiu, C. A. Popescu


Abstract: A newly identified infectious agent, SARS-CoV-2, has been the cause of the 2020’s pandemic, finding medical practitioners and researchers around the world in need for answers and data to support a course of treatment for a great number of patients, at a time when no specific medicine is known. We aim to review data concerning COVID-19 clinical studies, from the beginning of the pandemic and discuss their ethical framework. Latest data from June 2020 revealed approximately 1200 interventional-recruiting adult subject studies. World Health Organization stated, among other recommendations for COVID-19 research, that individual informed consent is a fundamental ethical requirement for research, even that having an informed consent on paper raises the possibility of contamination risk or a quarantine breach. The ethical considerations of the evaluated studies will be discussed with the framework for the Learning Health Care System, showing that all seven obligations are applicable for the search of treatment for COVID-19. The strongest argument against a Learning Health Care System in outbreaks would be that unethical practices will be carried out in the name of public health or emergency response efforts. From the very beginning of this pandemic, information came from the medical practice, observations made by the physicians that were acting in the best interest of the patient and not necessarily declared researchers, so the line between practice and research became blurred.
Keywords: Learning Health Care System, COVID-19, informed consent, ethics.



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