Twimukye Adelline, Nabukenya Sylvia, Kawuma Aida N, Bayigga Josephine, Nakijoba Ritah, Asiimwe Simon Peter, Byenume Fredrick, Ojara Francis Williams, Waitt Catriona
Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda.
Local Government, Hoima District, Hoima City, Hoima, Uganda.
BMC Med Ethics. 2024 Dec 21;25(1):149. doi: 10.1186/s12910-024-01147-4.
Appropriate language use is essential to ensure inclusion of diverse populations in research. We aimed to identify possible language-related barriers regarding the informed consent process and propose interventions to improve clarity and understanding of pregnant and breastfeeding women participating in research.
A cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August 2023 to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board members. 19 FGD comprised adult participants representing at least six different mother tongues (Luganda, Acholi, Runyankole, Runyoro, Lugbara and English). An inductive thematic approach was utilized for data analysis using NVivo version 12 software to identify language factors that influence informed consent. A series of community validation workshops ensured concurrence.
At the individual level, language barriers, and low levels of literacy contributed to poor comprehension, thus hindering ability to achieve genuine informed consent. At the health facility level, participants reported that there was use of inappropriate, unclear language including inaccurate translations, with poor and complicated grammar in some consent forms. Participants reported that complex medical terminologies are difficult to translate to local languages. Community members highlighted that social/cultural norms in language use affected cultural perceptions of informed consent. To enhance understanding for individuals without education in science, participants suggested simplification of terminologies and avoidance of complex medical jargon. Researchers should identify participants' preferred languages and communicate in those languages whenever possible. If researchers are not fluent, trained interpreters should be identified. Informed consent documents must be translated into local languages to ensure participants comprehend the study's purpose, procedures, risks, and benefits. Involving community members during development and translation of these documents can provide valuable insights into local dialects and culturally specific concepts, ensuring that study tools like surveys and consent forms are accurate and respectful.
Language barriers influence the informed consent process within communities in Uganda. These can potentially be resolved at individual, health system and community levels. Consideration of locally understandable terms in community-facing study documentation is likely to enhance understanding and could improve research participation, although further studies are needed to assess these. The use of appropriate language ensures that informed consent is genuine in keeping with principles of Good Clinical Practice, and developing a research communication strategy should be part of inclusive research design.
恰当的语言使用对于确保不同人群纳入研究至关重要。我们旨在确定在知情同意过程中可能存在的与语言相关的障碍，并提出干预措施，以提高参与研究的孕妇和哺乳期妇女对相关内容的清晰度和理解。
2023年8月至2023年9月在乌干达进行了一项采用焦点小组讨论（FGD）的横断面定性研究，涉及来自社区的不同利益相关者群体，包括社区成员、研究参与者和社区咨询委员会成员。19个焦点小组讨论由代表至少六种不同母语（卢干达语、阿乔利语、鲁尼扬科勒语、鲁尼奥罗语、卢格巴拉语和英语）的成年参与者组成。采用归纳主题分析法，使用NVivo 12软件进行数据分析，以确定影响知情同意的语言因素。一系列社区验证研讨会确保了一致性。
在个人层面，语言障碍和低识字水平导致理解能力差，从而阻碍了获得真正知情同意的能力。在卫生机构层面，参与者报告说存在使用不恰当、不清晰语言的情况，包括不准确的翻译，一些同意表格中的语法很差且复杂。参与者报告说复杂的医学术语很难翻译成当地语言。社区成员强调语言使用中的社会/文化规范影响了对知情同意的文化认知。为了增强对没有科学教育背景的个人的理解，参与者建议简化术语并避免使用复杂的医学行话。研究人员应确定参与者喜欢的语言，并尽可能用这些语言进行交流。如果研究人员不流利，应确定经过培训的口译员。知情同意文件必须翻译成当地语言，以确保参与者理解研究的目的、程序、风险和益处。在这些文件的制定和翻译过程中让社区成员参与，可以提供有关当地方言和文化特定概念的宝贵见解，确保调查问卷和同意表格等研究工具准确且尊重文化。
语言障碍影响乌干达社区内的知情同意过程。这些障碍有可能在个人、卫生系统和社区层面得到解决。在面向社区的研究文件中考虑使用当地易懂的术语可能会增强理解，并可能提高研究参与度，不过还需要进一步研究来评估这些。使用恰当的语言可确保知情同意符合良好临床实践原则且是真实的，制定研究沟通策略应成为包容性研究设计的一部分。
