Hanson-DeFusco Jessi, Davis Decontee, Bommareddy Meghana, Olaniyan Zainab Olayemi
Humanities, Social Sciences, and Communication Department, College of Arts and Sciences, Lawrence Technological University, Southfield, MI 48075, USA.
Winifred J. Harley College of Health Sciences, United Methodist University of Liberia, Monrovia 1000, Liberia.
Healthcare (Basel). 2024 Oct 5;12(19):1989. doi: 10.3390/healthcare12191989.
As the number of large-scale outbreaks continues to rise worldwide, clinical trials are increasingly engaging disease-affected peoples within the Minority World (nations with over 80% poverty rates). Yet global health research inadequately addresses potential ethical issues of including impoverished, disease-affected populations and their contextual vulnerabilities in medical research. This paper presents a mixed-method analysis from our 2022 semi-structured survey capturing the experiences of Liberian Ebola Virus Disease (EVD) survivors serving as study participants in the Partnership for Research on Ebola Virus in Liberia (PREVAIL) clinical trials. Firstly, we conducted an extensive literature review of the scholarship related to biomedical research and ethical standards protecting study participants to inform our survey method and design. Applying a theoretical framework on vulnerability, we then qualitatively explored the survey responses of 19 EVD survivors' perceptions and experiences taking part in PREVAIL, including their expectations, treatment, delivered benefits, and quality of care. We further quantitatively codified their statements for underlying themes of reported negative experiences against standard ethical regulations in biomedical research, conducting a statistical analysis to inform generalizability. Most of the 19 survivors reported facing extreme ongoing vulnerabilities related to their disease status, including physical impairments, psychosocial stress, and socio-economic inequity. Initially, the survivors tended to experience a sense of hope and pride in volunteering for PREVAIL. One in five participants reported benefiting from PREVAIL's regular medical diagnoses. However, most of their survey responses indicated prevalent negative shared experiences, including continually being confused or misinformed of their study participant rights, roles, and benefits; being burdened by heavy participation transaction costs; and repeated incidents of poor treatment and discrimination by PREVAIL staff after initial recruitment. PREVAIL participant satisfaction ranking is negatively correlated with receiving insufficient financial compensation (r = -0.51), extensive time requirements for each medical visit (-0.40), and being poorly treated by clinical staff (-0.67).
随着全球范围内大规模疫情爆发的数量持续上升，临床试验越来越多地让少数世界（贫困率超过80%的国家）中受疾病影响的人群参与进来。然而，全球卫生研究未能充分解决将贫困、受疾病影响的人群及其背景下的脆弱性纳入医学研究可能产生的伦理问题。本文呈现了一项混合方法分析，该分析来自于我们2022年的半结构化调查，该调查记录了利比里亚埃博拉病毒病（EVD）幸存者作为利比里亚埃博拉病毒研究伙伴关系（PREVAIL）临床试验研究参与者的经历。首先，我们对与生物医学研究以及保护研究参与者的伦理标准相关的学术文献进行了广泛的综述，以为我们的调查方法和设计提供信息。应用关于脆弱性的理论框架，我们随后定性地探究了19名埃博拉病毒病幸存者参与PREVAIL的认知和经历的调查回复，包括他们的期望、治疗、获得的益处以及护理质量。我们进一步对他们的陈述进行定量编码，以找出针对生物医学研究标准伦理规范所报告的负面经历的潜在主题，并进行统计分析以了解普遍性。19名幸存者中的大多数报告称，他们因疾病状况面临着持续的极端脆弱性，包括身体损伤、心理社会压力和社会经济不平等。最初，幸存者们在自愿参与PREVAIL时往往会感到希望和自豪。五分之一的参与者报告称从PREVAIL的定期医学诊断中受益。然而，他们的大多数调查回复表明存在普遍的负面共同经历，包括不断对自己作为研究参与者的权利、角色和益处感到困惑或得到错误信息；被沉重的参与交易成本所负担；以及在初次招募后，PREVAIL工作人员多次出现治疗不善和歧视的情况。PREVAIL参与者满意度排名与获得的经济补偿不足（r = -0.51）、每次就诊所需的大量时间（-0.40）以及受到临床工作人员的恶劣对待（-0.67）呈负相关。
