David Pierre-Marie, Mathiot Benjamin, Thiongane Oumy, Graham Janice E
Faculté de Pharmacie, Université de Montréal, C.P. 6128, Succursale Centre-Ville, Montreal, H3C 3J7, Canada.
Département d'anthropologie, Université de Montréal, Pavillon Lionel-Groulx C. P. 6128, Succursale Centre-Ville, Montreal, QC, H3C 3J7, Canada.
BMC Med Ethics. 2021 Apr 9;22(1):42. doi: 10.1186/s12910-021-00606-6.
Little is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate.
Observation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants' stories to develop two ideal portraits based on "composite characters" based on study participants features. These provide ethnographically rich details of participants' meaningful social worlds while protecting individual identities.
Ten of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation.
Our findings support Fisher's argument of "structural coercion" in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie "under consent" of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North.
对于来自北方研究机构、参与尚无获批治疗方法的高传染性疾病疫苗试验的志愿者，我们了解甚少。本文探讨了加拿大参与一项评估埃博拉候选疫苗安全性和免疫原性的II期临床试验的HIV免疫受损研究参与者的动机。
在一年多的时间里，对临床试验参与者和工作人员进行了临床研究现场观察以及采用情境和话语分析的半结构化访谈。访谈进行了录音、转录，并使用批判性定性解释主义主题分析技术进行分析。识别、聚类和整理模式以生成独特而全面的主题。然后，我们根据研究参与者的特征，从他们的故事中重新梳理事件和背景，以“复合人物”为基础构建了两个理想画像。这些画像在保护个人身份的同时，提供了参与者有意义的社会世界的丰富民族志细节。
对14名临床试验参与者中的10名以及3名研究工作人员进行了访谈。参与者的人口统计学和社会经济概况显示背景多样性有限。一半是男同性恋者，一半是曾经历无家可归的前注射吸毒者，一名是女性，没有少数族裔，也没有来自HIV流行国家的人。90%的人以前参与过其他临床研究。他们的故事指向了促使他们通过参与试验成为临床劳动力的特定社会经济状况。
我们的研究结果支持了费舍尔关于在招募生活条件不稳定的弱势群体参与临床试验时存在“结构性胁迫”的观点。临床试验应提供更多关于研究参与者“同意背后”的结构性社会经济状况和医疗需求的细节。伦理审议框架需要远远超越过于简单的利他主义叙述，充分考虑临床试验的结构性条件。我们为此提供了具体的可能性，并承认应提供更多关于南方和北方资源匮乏地区研究参与者招募和参与情况的研究及临床数据。
