Background The informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors. Objectives This study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam. Methods We used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions. Results We use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings. Conclusions Our findings show how practices of informed consent and fragemented understanding are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place.

Antibiotic use in the community for humans and animals is high in Vietnam, driven by easy access to over-the counter medicines and poor understanding of the role of antibiotics. This has contributed to antibiotic resistance levels that are amongst the highest in the world. To address this problem, we developed a participatory learning and action (PLA) intervention. Here we describe challenges and lessons learned while developing and testing this intervention in preparation for a large-scale One Health trial in northern Vietnam. We tested the PLA approach using community-led photography, and then reflected on how this approach worked in practice. We reviewed and discussed implementation documentation and developed and refined themes. Five main themes were identified related to challenges and lessons learned: understanding the local context, stakeholder relationship development, participant recruitment, building trust and motivation, and engagement with the topic of antibiotics and antimicrobial resistance (AMR). Partnerships with national and local authorities provided an important foundation for building relationships with communities, and enhanced visibility and credibility of activities. Partnership development required managing relationships, clarifying roles, and accommodating different management styles. When recruiting participants, we had to balance preferences for top-down and bottom-up approaches. Building trust and motivation took time and was challenged by limited study team presence in the community. Open discussions around expectations and appropriate incentives were re-visited throughout the process. Financial incentives provided initial motivation to participate, while less tangible benefits like collective knowledge, social connections, desire to help the community, and new skills, sustained longer-term motivation. Lack of awareness and perceived importance of the problem of AMR, affected initial motivation. Developing mutual understanding through use of common and simplified language helped when discussing the complexities of this topic. A sense of ownership emerged as the study progressed and participants understood more about AMR, how it related to their own concerns, and incorporated their own ideas into activities. PLA can be a powerful way of stimulating community action and bringing people together to tackle a common problem. Understanding the nuances of local power structures, and allowing time for stakeholder relationship development and consensus-building are important considerations when designing engagement projects.

Background The informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors. Objectives This study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam. Methods We used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions. Results We use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings. Conclusions Our findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place.