Ethical and practical considerations arising from community consultation on implementing controlled human infection studies using <i>Schistosoma mansoni</i> in Uganda

Issues related to controlled human infection studies using <i>Schistosoma mansoni</i> (CHI-S) were explored to ensure the ethical and voluntary participation of potential CHI-S volunteers in an endemic setting in Uganda. We invited volunteers from a fishing community and a tertiary education community to guide the development of informed consent procedures. Consultative group discussions were held to modify educational materials on schistosomiasis, vaccines and the CHI-S model and similar discussions were held with a test group. With both groups, a mock consent process was conducted. Fourteen in-depth key informant interviews and three group discussions were held to explore perceptions towards participating in a CHI-S. Most of the participants had not heard of the CHI-S. Willingness to take part depended on understanding the study procedures and the consenting process. Close social networks were key in deciding to take part. The worry of adverse effects was cited as a possible hindrance to taking part. Volunteer time compensation was unclear for a CHI-S. Potential volunteers in these communities are willing to take part in a CHI-S. Community engagement is needed to build trust and time must be taken to share study procedures and ensure understanding of key messages.本研究针对乌干达血吸虫病流行区域内，使用曼氏血吸虫（Schistosoma mansoni）的受控人体感染研究（CHI-S）相关伦理议题展开探索，以保障潜在研究志愿者能够在符合伦理规范且自愿的前提下参与该研究。研究团队邀请了来自渔业社区与高等教育社区的志愿者，协助制定知情同意流程。期间开展咨询小组研讨，以修订血吸虫病、疫苗及CHI-S模型相关的宣教材料，同时针对测试组开展了同类研讨活动；两组均开展了模拟知情同意流程演练。通过14次深度关键知情人访谈与3次小组讨论，探究了受试者对参与CHI-S研究的认知态度。多数参与者此前未听闻过CHI-S研究，其参与意愿取决于对研究流程与知情同意流程的理解程度。紧密的社会关系网络是决定是否参与研究的关键因素，对不良反应的担忧被视为参与研究的潜在阻碍，且CHI-S研究的志愿者工时补偿机制尚不明确。上述两类社区的潜在志愿者均有意愿参与CHI-S研究，需通过社区参与建立信任，并投入充足时间阐释研究流程，确保参与者准确理解核心信息。