Gillette Emma, Nyandiko Winstone, Chory Ashley, Scanlon Michael, Aluoch Josephine, Koros Hillary, Ashimosi Celestine, Biegon Whitney, Munyoro Dennis, Lidweye Janet, Nyagaya Jack, DeLong Allison, Kantor Rami, Vreeman Rachel, Naanyu Violet
Department of Global Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
College of Health Sciences, Moi University, Eldoret, Kenya.
BMC Med Ethics. 2025 May 16;26(1):63. doi: 10.1186/s12910-025-01225-1.
Involving children and adolescents (youth) living with HIV (YLWH) in research is critical for developing appropriate HIV care services and interventions. However, this vulnerable population may not adequately weigh risks against benefits when participating in research, forming an ethical concern, yet little is known about how YLWH perceive these risks and benefits. To inform research-related policies and procedures, we sought perspectives of Kenyan YLWH, their caregivers and subject matter experts (SMEs) on risks and benefits of participation in research in a setting with a high burden of youth HIV infection.
We conducted a qualitative inquiry on identifying, enrolling, and protecting YLWH (age 10-24 years) in research using semi-structured interviews with YLWH involved in research, their caregivers, YLWH with no prior research experience, and other SMEs at the AMPATH care and research sites in western Kenya. Transcripts were thematically analyzed and emerging themes derived to characterize perspectives of each group on risks and benefits of engaging YLWH in research.
Interviews were conducted with 40 YLWH (50% female; median age 17.5 years), 20 caregivers (70% female), and 39 SMEs [healthcare providers (N = 10), community leaders (N = 10) community advisory board members (N = 4), IRB experts (N = 5), clinical researchers (N = 6), social science researchers (N = 4) and laboratory experts (N = 1).] Participants in all groups identified accidental disclosure of HIV status, stigma and discrimination, risks of blood draws, mental health effects, and coercion due to study compensation as risks of research involvement. Benefits fell into 5 categories: clinical, informational, personal, future and community or household benefits. Benefits included access to health care, learning about HIV, gaining hope and community, improving HIV care, and reducing stigma. All participant groups largely held similar views; however, caregivers were the only group to identify misuse of study compensation as a risk, and YLWH less frequently cited clinical benefits.
These findings suggest that participants commonly cite indirect risks and benefits of research participation, yet these are often excluded from institutional guidelines for consent documentation. Researchers should consider including indirect risks and benefits, such as the risk of stigma or the benefit of gaining knowledge and community, to study documentation.
让感染艾滋病毒的儿童和青少年（青年）参与研究对于开发合适的艾滋病毒护理服务和干预措施至关重要。然而，这一弱势群体在参与研究时可能无法充分权衡风险与益处，这引发了伦理方面的担忧，而对于感染艾滋病毒的儿童和青少年如何看待这些风险和益处却知之甚少。为了为与研究相关的政策和程序提供信息，我们征求了肯尼亚感染艾滋病毒的儿童和青少年、他们的照料者以及主题专家（SMEs）对于在青年艾滋病毒感染负担较重的环境中参与研究的风险和益处的看法。
我们采用定性研究方法，通过对参与研究的感染艾滋病毒的儿童和青少年（10 - 24岁）、他们的照料者、此前没有研究经验的感染艾滋病毒的儿童和青少年以及肯尼亚西部AMPATH护理和研究点的其他主题专家进行半结构化访谈，来确定、招募和保护感染艾滋病毒的儿童和青少年参与研究。对访谈记录进行主题分析，并得出新出现的主题，以描述每个群体对于让感染艾滋病毒的儿童和青少年参与研究的风险和益处的看法。
我们对40名感染艾滋病毒的儿童和青少年（50%为女性；中位年龄17.5岁）、20名照料者（70%为女性）和39名主题专家[医疗保健提供者（N = 10）、社区领袖（N = 10）、社区咨询委员会成员（N = 4）、机构审查委员会专家（N = 5）临床研究人员（N = 6）、社会科学研究人员（N = 4）和实验室专家（N = 1）]进行了访谈。所有群体的参与者都将艾滋病毒感染状况的意外披露、耻辱和歧视、抽血风险、心理健康影响以及因研究补偿导致的胁迫视为参与研究的风险。益处分为5类：临床、信息、个人、未来以及社区或家庭益处。益处包括获得医疗保健、了解艾滋病毒、获得希望和融入社区、改善艾滋病毒护理以及减少耻辱感。所有参与群体的观点基本相似；然而，照料者是唯一将研究补偿的不当使用视为风险的群体，而感染艾滋病毒的儿童和青少年较少提及临床益处。
这些发现表明，参与者普遍提到了参与研究的间接风险和益处，但这些往往被排除在机构同意文件指南之外。研究人员应考虑将间接风险和益处，如耻辱感风险或获得知识和融入社区的益处，纳入研究文件中。
