COVID-19疫情下研究護理師之臨床研究倫理困境

Ethical Dilemmas Encountered by Clinical Research Nurses During the COVID-19 Pandemic

葉小瑜(Hsiao-Yu Yeh) ； 張榮珍(Jung-Chen Chang)

《台灣醫學》 25卷6期 (2021/11) Pp. 836-842

https://doi.org/10.6320/FJM.202111_25(6).0015

摘要

本文旨在藉由國外經驗探討於COVID-19疫情衝擊下的臨床研究倫理困境。疫情期間，大量確診或疑似感染的患者史無前例地湧入各醫院，病床及醫療資源呈現不敷使用，引發了本就存在爭議的醫療倫理問題浮上檯面，不僅涉及生命支持系統使用取捨的決策、患者的分流和撤出、家庭臨终的探視權、照護的品質及緊急醫療需求等皆受到劇烈的影響，臨床研究相關的機構面臨考驗及困境，並嚴重衝擊了護理人員的內心道德倫理。為確保臨床研究執行具有優良品質，保障受試者的受試權益及降低研究的中斷、偏差或終止，如能在相關法規中，開放研究護理師的更彈性授權，推動遠距醫療的實施，將可能會降低臨床研究的倫理困境，期許在疫情尚未看到終點曙光的現況下，能為台灣臨床研究帶來持續推動，並增進社會福祉。

關鍵字

COVID-19 ； 臨床研究 ； 臨床研究護理師 ； 倫理困境

並列摘要

This article aims to discuss the ethical dilemmas of clinical research nurses under the impact of COVID-19 pandemic. During the pandemic period, patients poured into hospitals and leaded to several ethical problems. The shortage of hospital beds and medical supplies triggered several controversial medical ethical issues. Some arguable ethical issues which emerged in the epidemic included decision-making of life support system, visiting rights, the quality of care and the other emergency medical needs. Clinical research institutions are facing challenges and difficulties as well. Clinical research nurses are experiencing moral distress and ethical challenges between the integrity of clinical trials and the protections of the study participants' rights and wellbeing. In order to ensure the quality of implementation of clinical research, to protect the participants' rights and to reduce the interruption, deviation or termination of the study, we recommend to give clinical research nurses flexible delegations and authorizations by laws and regulations, and to promote multiple implementations of telemedicine to reduce the ethical dilemma of clinical research trial even still in the pandemic era.

並列關鍵字

COVID-19 ； clinical research ； clinical research nurse (CRN) ； ethical dilemma

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