由社會正義的觀點檢視「人體挑戰試驗」

Human Challenge Trial: From a Social Justice Perspective

顧長欣(Chang-Hsin Ku)

《新實踐集刊》 2期 (2022/03) Pp. 39-76

https://doi.org/10.29634/JNP.202203_(2).0002

摘要

自2019年底，新冠肺炎（COVID-19）傳染疾病引發了全球性的公共衛生危機。為了減緩疫情的傳播，有學者提出在疫苗的研發過程，應採取「人體挑戰試驗」（Human Challenge Trial）這個研究方法，透過「有意的」讓受試者感染新冠肺炎，來精準的瞭解完整病程及免疫反應，加速疫苗的設計與製造。然而，在尚無有效治療方式的情況下，讓某部分人（受試者）冒著生命危險感染疾病，研發有效的疫苗，來保障大多數人的健康與安全，是否符合社會正義？實際上英國在2021年2月已經開始進行COVID-19的SARS-CoV-2疫苗的人體挑戰試驗，但這是符合倫理的嗎？本文將先透過基礎的哲學探討，及研究倫理實務的應用，探討普遍意義的人體挑戰試驗本身的倫理性，再以具體COVID-19的SARS-CoV-2疫苗的人體挑戰試驗為例進行驗證，探究在自由社會的前提下，規劃及執行這樣的試驗，是否有其道德根據與基礎。

關鍵字

新冠肺炎 ； 人體挑戰試驗 ； 社會正義 ； 研究倫理

並列摘要

The global public health crisis of Covid-19 pandemic took a heavy toll on human lives in the whole world. In order to develop effective vaccines in a short time, some scholars suggest to apply Human Challenge Model in SARS-CoV-2 vaccine development process, which involves the intentional infection of trial subjects to acquire direct data of the disease and immunological information to accelerate the procedure of vaccine manufacture and licensure. The Challenge Model had already been implemented in the United Kingdom in 2021. However, is this a safe and ethical research method for human subjects while there is no effective treatment for COVID-19 yet? Is this a just way to sacrifice a small number of people for securing the well-being of other people? In response to it, there are some basic requirements for the Human Challenge Trial to meet if it can be regarded as a morally acceptable method. Related elaborations from both philosophical and practical perspectives are shown in this paper.

並列關鍵字

Covid-19 Pandemic ； Human Challenge Trial ； Social Justice ； Research Ethics

參考文獻

Callaway, Ewen. 2020. “Dozens to Be Deliberately Infected With Coronavirus in UK’ Human Challenge’ Trials”. Nature 586: 651-652.

Cordeiro-Rodrigues, Luís.2020. “Social Justice for Public Health: The COVID-19 Response in Portugal.” Bioethical Inquiry 17(4): 669-674.

Davis, Hannah E. et al. 2021. Characterizing Long COVID in an International Cohort: 7 Months of Symptoms and their Impact. EClinicalMedicine, Online ahead of print https://doi.org/10.1016/j.eclinm.2021.101019

Davies, Hugh (On behalf of the HRA Specialist Research Ethics Committee). 2021. UK Research Ethics Committee’s review of the global first SARS-CoV-2 human infection challenge studies. Journal of Medical Ethics Published Online First: 05 October 2021. doi: 10.1136/medethics-2021-107709

Eyal, Nir, Marc Lipsitch and Peter G. Smith. 2020. “Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure.” The Journal of Infectious Diseases 221(11): 1752-1756.