Some parts in the consent form are written using complex scientific language: Community members’ perspectives regarding terminologies used during informed consent process for research involving pregnant and lactating mothers in Uganda

Abstract

<title>Abstract</title> Background 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 and suggest interventions to enhance goal of the informed consent processes. Methods A cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board (CAB) members. 19 FGD comprised individuals aged 18 years and over. Participants represented 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. Terminologies were discussed in a community validation workshop. Results At the individual level, language barriers, and low understanding of written information due to illiteracy contribute to community members’ poor comprehension, thus hindering their ability to achieve informed consent. At the health facility level, participants reported that there was use of inappropriate, unclear language including inaccurate translations, and 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 trends in language use affected cultural perceptions of informed consent. They emphasized the need for respectful communication, particularly towards women. Participants suggested use of appropriate language, availing translated informed consent document in respective appropriate local languages, simplifying terminologies in the consent forms, adapting to the local context and involvement of community members in language matters of study protocols from design stage. Conclusion Language barriers influence the informed consent process within communities in Uganda. These can potentially be resolved at individual, health system and community levels. Integrating considerations of language and development of appropriate language terminologies in informed consent process as well as long-term planning of research communication could improve research participation among pregnant and lactating mothers in Uganda. The use of appropriate language enhances informed consent in keeping with principles of Good Clinical Practice.