Colom Marcela, Rohloff Peter
Centre for Research in Indigenous Health, Wuqu' Kawoq | Maya Health Alliance, Tecpán, Guatemala.
Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
BMJ Paediatr Open. 2018 Dec 5;2(1):e000298. doi: 10.1136/bmjpo-2018-000298. eCollection 2018.
Conducting research with children in low/middle-income countries (LMIC) requires consideration of socioeconomic inequalities and cultural and linguistic differences. Our objective was to survey the literature on informed consent in paediatric LMIC research, assessing for practical guidance for culturally and linguistically appropriate procedures.
We conducted a scoping review on informed consent in paediatric LMIC research searching the PubMed, Web of Science and PsycINFO databases. Eligible articles were published in English, from any date range, of any study design or format.
The search identified 2027 references, of which 50 were included in the analysis following full-text review. Reviewed guidelines emphasised individual, informed and voluntary consent from parents and caregivers. Reviewed articles provided detailed practical guidance on adapting these guiding principles to LMIC settings, including considerations for community engagement, verbal or other alternative consent procedures for low-literacy settings or less commonly spoken languages and guarding against therapeutic misconception by caregivers. There was uncertainty, however, on how to best protect individual autonomy, especially when influenced by gender dynamics, leadership hierarchies or the social status of researchers themselves. There was, furthermore, limited research discussing the special case of research involving adolescents or of procedures for documenting assent by participating children.
A scoping review of paediatric research in LMICs revealed substantial guidance on several features of culturally appropriate informed consent. However, additional research and guidance is needed, especially in the areas of gender imbalances, research with adolescents and children's own assent to participate in research.
在低收入/中等收入国家（LMIC）对儿童进行研究需要考虑社会经济不平等以及文化和语言差异。我们的目标是调查关于LMIC儿科研究中知情同意的文献，评估在文化和语言方面适当程序的实际指导。
我们对LMIC儿科研究中的知情同意进行了范围审查，检索了PubMed、科学引文索引和心理学文摘数据库。符合条件的文章以英文发表，不限日期范围，不限研究设计或格式。
检索共识别出2027篇参考文献，其中50篇在全文审查后纳入分析。审查的指南强调父母和照顾者的个人、知情和自愿同意。审查的文章提供了关于如何将这些指导原则应用于LMIC环境的详细实际指导，包括社区参与的考虑因素、针对低识字率环境或使用较少语言的口头或其他替代同意程序，以及防止照顾者产生治疗误解。然而，在如何最好地保护个人自主权方面存在不确定性，尤其是在受到性别动态、领导层级或研究人员自身社会地位影响时。此外，讨论涉及青少年的研究特殊情况或记录参与儿童同意的程序的研究有限。
对LMIC儿科研究的范围审查揭示了关于文化上适当的知情同意的几个特征的大量指导。然而，还需要更多的研究和指导，特别是在性别失衡、青少年研究以及儿童自身同意参与研究等领域。
