BACKGROUND Human infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMICs. METHODS We conducted 6 deliberative focus groups and 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members, and district health government officials. RESULTS Stakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to the safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example, balancing equity, safety, and relevance in inclusion criteria. CONCLUSIONS Our findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out.

中文翻译：

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利益相关者对马拉维人类感染研究可接受性的看法。

背景人类感染研究（HIS）对于疫苗开发很有价值。然而，故意感染会带来具有挑战性的问题，特别是在低收入和中等收入国家 (LMIC)，这些国家的 HIS 是新事物，伦理挑战可能会加剧。需要与利益相关者进行协商，以支持适合具体情况且可接受的研究设计。我们研究了利益相关者对马拉维 HIS 可接受性和道德的看法，为有关计划的肺炎球菌挑战研究的决策和中低收入国家对 HIS 道德的更广泛理解提供信息。方法 我们对来自布兰太尔农村和城市的研究人员、医学生和社区代表进行了 6 个审议焦点小组和 15 次后续访谈。我们还对临床医生、伦理委员会成员和地区卫生政府官员进行了 5 次关键知情人访谈。结果 利益相关者认为 HIS 研究具有潜在的人口健康益处，但他们也有担忧，特别是与志愿者的安全和负面社区反应有关的担忧。可接受性取决于与自愿和知情同意程序、纳入标准、医疗护理或支持、补偿、监管和强有力的社区参与相关的一系列条件。这些条件在很大程度上反映了中低收入国家 HIS 和生物医学研究现有指南中的条件。利益相关者的看法指出了潜在的紧张局势，例如，平衡公平性、安全性和纳入标准的相关性。结论 我们的研究结果表明，只要具备一定的条件，他的研究在马拉维是可以接受的。需要对参与者的经验和利益相关者的看法进行持续评估，以在开发和推广过程中加强 HIS 研究。