Improving Ethical and Participatory Practice for Marginalized Populations in Biomedical HIV Prevention Trials: Lessons from Thailand

Abstract

BackgroundThis 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.MethodsIn-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.ResultsFourteen 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.DiscussionBiomedical 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.

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

“…In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 and low‐income (nine studies; 8.3%) 101, 102, 103, 104, 105, 106, 107, 108, 109 countries. The location of stakeholder engagement could not be discerned in six studies (5.6%) 110, 111, 112, 113, 114, 115, and fifteen studies (13.9%) 16, 24, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128 conducted stakeholder engagement in multiple countries at different income levels.…”

“…The second and third most frequent purpose for conducting stakeholder engagement was to inform the ethical conduct of the trial (16 studies) and to develop trial tools (15 studies) respectively. In informing the ethical conduct of trials, stakeholders were engaged for providing input on ethicsrelated concerns, either in terms of the overall trial process [70,76,88,99] or in relation to particular aspects of the trial; for example, trial stopping rules [78], trial communication strategies [123] and concepts of fairness in the research relationship [94].…”

Defining and Negotiating the Social Value of Research in Public Health Facilities: Perceptions of Stakeholders in a Research‐Active Province of South Africa

“…Health managers’ views of researchers may be partly anchored in knowledge of past exploitative research that took place in South Africa, 62 or even in perceptions that researchers are part of a social elite. 6364 It is also possible that health managers possess lower levels of research literacy than researchers 65 which might undermine their assessment of the knowledge-generation value of research.…”

“…141516171819202122 There have also been a number of studies investigating the related concept of research benefits. 23242526 However, to date, much of the literature has tended to define the inherent value of research according to its contribution to new knowledge, and this has been the point of departure for empirical studies on this subject.…”

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“…The second and third most frequent purpose for conducting stakeholder engagement was to inform the ethical conduct of the trial (16 studies) and to develop trial tools (15 studies) respectively. In informing the ethical conduct of trials, stakeholders were engaged for providing input on ethicsrelated concerns, either in terms of the overall trial process [70,76,88,99] or in relation to particular aspects of the trial; for example, trial stopping rules [78], trial communication strategies [123] and concepts of fairness in the research relationship [94].…”