Health Systems and Research Ethics Department, 285561KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, 6396University of Oxford, Oxford, UK.
J Empir Res Hum Res Ethics. 2021 Jul;16(3):238-254. doi: 10.1177/15562646211005304. Epub 2021 Mar 25.
Pediatric clinical research in low-resourced countries involves individuals defined as "vulnerable" in research ethics guidance. Insights from research participants can strengthen the design and oversight of studies. We share family members' perspectives and experiences of an observational clinical study conducted in one Kenyan hospital as part of an integrated empirical ethics study. Employing qualitative methods, we explored how research encounters featured in family members' care-seeking journeys. Our data reveals that children's vulnerability is intricately interwoven with that of their families, and that research processes and procedures can inadvertently add to hidden burdens for families. In research, the potential for layered and intersecting situational and structural vulnerability should be considered, and participants' agency in constrained research contexts actively recognized and protected.
在资源匮乏国家开展儿科临床研究涉及到研究伦理指导中被定义为“弱势”的个体。研究参与者的意见可以加强研究的设计和监督。我们分享了肯尼亚一家医院进行的一项观察性临床研究中家庭成员的观点和经验，该研究是综合经验伦理研究的一部分。采用定性方法，我们探讨了研究遭遇如何出现在家庭成员的求医过程中。我们的数据表明，儿童的脆弱性与他们家庭的脆弱性错综复杂地交织在一起，研究过程和程序可能会给家庭带来隐藏的负担。在研究中，应该考虑潜在的分层和交叉的情境和结构性脆弱性，并积极认识和保护参与者在受限研究环境中的能动性。
