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https://doi.org/10.1007/s11673-022-10171-1
Title: | Professional Oversight of Emergency-Use Interventions and Monitoring Systems: Ethical Guidance From the Singapore Experience of COVID-19 | Authors: | Lysaght, Tamra Schaefer, Gerald Owen Voo, Teck Chuan Wee, Hwee Lin Joseph, Roy |
Keywords: | Social Sciences Science & Technology Life Sciences & Biomedicine Ethics Medical Ethics Social Issues Social Sciences, Biomedical Social Sciences - Other Topics Biomedical Social Sciences COVID-19 Emerging communicable diseases Ethical framework Professional ethics MEDICAL-ETHICS ACCESS |
Issue Date: | 14-Apr-2022 | Publisher: | SPRINGER | Citation: | Lysaght, Tamra, Schaefer, Gerald Owen, Voo, Teck Chuan, Wee, Hwee Lin, Joseph, Roy (2022-04-14). Professional Oversight of Emergency-Use Interventions and Monitoring Systems: Ethical Guidance From the Singapore Experience of COVID-19. JOURNAL OF BIOETHICAL INQUIRY 19 (2). ScholarBank@NUS Repository. https://doi.org/10.1007/s11673-022-10171-1 | Abstract: | 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. | Source Title: | JOURNAL OF BIOETHICAL INQUIRY | URI: | https://scholarbank.nus.edu.sg/handle/10635/228258 | ISSN: | 11767529 18724353 |
DOI: | 10.1007/s11673-022-10171-1 |
Appears in Collections: | Staff Publications Elements |
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