题名

COVID-19疫情下研究護理師之臨床研究倫理困境

并列篇名

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

DOI

10.6320/FJM.202111_25(6).0015

作者

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

关键词

COVID-19 ; 臨床研究 ; 臨床研究護理師 ; 倫理困境 ; COVID-19 ; clinical research ; clinical research nurse (CRN) ; ethical dilemma

期刊名称

台灣醫學

卷期/出版年月

25卷6期(2021 / 11 / 25)

页次

836 - 842

内容语文

繁體中文

中文摘要

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。

英文摘要

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.

主题分类 醫藥衛生 > 醫藥衛生綜合
参考文献
  1. Shrestha N, Shad MY, Ulvi O, et al. The impact of Covid-19 on globalization. One Health 2020;11:100180.
    連結:
  2. 蔡甫昌:參與臨床試驗的倫理考量。健康世界2012;321;36-41。
    連結:
  3. Muthuswamy V. Ethical issues in clinical research. Perspect Clin Res 2013;4;9.
    連結:
  4. 江宜珊:探討護理人員臨床醫學倫理困境之解決--以某醫學中心為例。碩士論文。台灣,臺北醫學大學,2011。
    連結:
  5. Tuttle KR. Impact of the Covid-19 pandemic on clinical research. Nat Rev Nephrol 2020;16;562-4.
    連結:
  6. Iacobucci G. Covid-19: all non-urgent elective surgery is suspended for at least three months in England. BMJ 2020;368:m1106.
    連結:
  7. Robert R, Kentish-Barnes N, Boyer A, et al. Ethical dilemmas due to the Covid-19 pandemic. Ann Intensive Care 2020;10;84.
    連結:
  8. 鄭君婷、林秋菊:知情同意於護理臨床實務之運用。護理雜誌2017;64;1:98-104
    連結:
  9. Debra J, Caroline BJ, Diana B, et al. Life in the pandemic: some reflections on nursing in the context of Covid-19. J Clin Nurs 2020;29:13-4.
    連結:
  10. Brøgger-Mikkelsen M, Ali Z, Zibert JR, et al. Online patient recruitment in clinical trials: systematic review and meta-analysis. J Med Internet Res. 2020;22:e22179.
    連結:
  11. Mirza M, Siebert S, Pratt A, et al: Impact of the Covid‐19 pandemic on recruitment to clinical research studies in rheumatology. Musculoskeletal Care 2021;10.1002/msc.1561.
    連結:
  12. Bierer BE, White SA, Barnes JM, et al. Ethical challenges in clinical research during the Covid-19 pandemic. J Bioeth Inq 2020;17:717-22.
    連結:
  13. World Health Organization: Naming the coronavirus disease (COVID-19) and the virus that causes it, 2021.https://www.who.int/ emergencies/diseases/novel-coronavirus-2019/ technical-guidance/naming-the-coronavirus-disease-(COVID-2019)-and-the-virus-that-causes-it/ Accessed July 1, 2021
  14. 衛生福利部疾病管制署:嚴重特殊傳染性肺炎疾病介紹。臺北,疾病管制署,2021。
  15. World Health Organization: COVID-19 Public Health Emergency of International Concern (PHEIC) Global research and innovation forum, 2021. https://www.who.int/publications/m/item/ COVID-19-public-health-emergency-of-international-concern-(pheic)-global-research-and-innovation-forum /Accessed on July 1, 2021.
  16. United Nations Office on Drugs and Crime: Message on the International Day of Multilateralism and Diplomacy for Peace, 2020. https://www.unodc.org/unodc/en/press/releases/2020/April/the-secretary-generals-message-on-the-international-day-of-multilateralism-and-diplomacy-for-peace.html/ Accessed on July 1, 2021.
  17. Sorice V, Gardner J. Informed consent: the research nurse role during the coronavirus pandemic. Nursing Times 2021;117:6,33-6.