Allman Dan, Ditmore Melissa Hope, Kaplan Karyn
Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; The CIHR Social Research Centre in HIV Prevention (SRC), Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
Sex Workers Project, Urban Justice Center, New York, New York, United States of America.
PLoS One. 2014 Jun 20;9(6):e100058. doi: 10.1371/journal.pone.0100058. eCollection 2014.
This paper presents findings from a qualitative investigation of ethical and participatory issues related to the conduct of biomedical HIV prevention trials among marginalized populations in Thailand. This research was deemed important to conduct, as several large-scale biomedical HIV prevention trials among marginalized populations had closed prematurely in other countries, and a better understanding of how to prevent similar trial closures from occurring in the future was desired.
In-depth key informant interviews were held in Bangkok and Chiang Mai, Thailand. Interviews were audio recorded, transcribed, translated and thematically analyzed. The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP) guided this work.
Fourteen interviews were conducted: 10 with policymakers, academic and community-based researchers and trial staff and four with representatives of non-governmental organizations (NGOs). Suggested ways to improve ethical and participatory practice centered on standards of HIV prevention, informed consent, communication and human rights. In particular, the need to overcome language and literacy differences was identified. Key informants felt communication was the basis of ethical understanding and trust within biomedical HIV prevention trial contexts, and thus fundamental to trial participants' ability to exercise free will.
Biomedical HIV prevention trials present opportunities for inclusive and productive ethical and participatory practice. Key informants suggested that efforts to improve practice could result in better relationships between research stakeholders and research investigative teams and by extension, better, more ethical participatory trials. This research took place in Thailand and its findings apply primarily to Thailand. However, given the universality of many ethical considerations, the results of this study can inform the improvement of ethical and participatory practice in other parts of the world where biomedical HIV prevention trials occur, and where clinical trials in marginalized populations continue.
本文展示了一项定性研究的结果，该研究涉及泰国边缘化人群中开展生物医学艾滋病毒预防试验的伦理和参与性问题。开展这项研究被认为很重要，因为在其他国家，一些针对边缘化人群的大规模生物医学艾滋病毒预防试验过早结束，人们希望更好地理解如何防止未来发生类似的试验终止情况。
在泰国曼谷和清迈进行了深入的关键信息提供者访谈。访谈进行了录音、转录、翻译并进行了主题分析。生物医学艾滋病毒预防试验的良好参与实践指南（GPP）指导了这项工作。
进行了14次访谈：10次访谈对象是政策制定者、学术和社区研究人员以及试验工作人员，4次访谈对象是非政府组织（NGO）的代表。提出的改善伦理和参与实践的方法集中在艾滋病毒预防标准、知情同意、沟通和人权方面。特别是，确定了克服语言和识字差异的必要性。关键信息提供者认为沟通是生物医学艾滋病毒预防试验背景下伦理理解和信任的基础，因此对于试验参与者行使自由意志的能力至关重要。
生物医学艾滋病毒预防试验为包容性和富有成效的伦理和参与实践提供了机会。关键信息提供者建议，改善实践的努力可以改善研究利益相关者与研究调查团队之间的关系，进而开展更好、更符合伦理的参与性试验。这项研究在泰国进行，其结果主要适用于泰国。然而，鉴于许多伦理考量具有普遍性，本研究结果可为世界其他地区改善伦理和参与实践提供参考，这些地区开展生物医学艾滋病毒预防试验，且继续在边缘化人群中进行临床试验。
