Naemiratch Bhensri, Kulpijit Natinee, Ruangkajorn Supanat, Day Nicholas P J, Prachumsri Jetsumon, Cheah Phaik Yeong
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Thunphayathai, Bangkok, 10400, Thailand.
Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
BMC Med Ethics. 2025 Jan 28;26(1):14. doi: 10.1186/s12910-024-01160-7.
Thailand has made significant progress in malaria control efforts in the past decade, with a decline in the number of reported cases. However, due to cross-border movements over the past 5 years, reported malaria cases in Thailand have risen. The Malaria Infection Study in Thailand (MIST) involves deliberate infection of healthy volunteers with Plasmodium vivax malaria parasites, and the assessment of the efficacy of potential vaccine and drug candidates in order to understand acquired protection against malaria parasites.
This paper drew from ethics and social science qualitative study called MIST-ETHICS embedded within the MIST studies. MIST-ETHICS aimed to describe and understand the experiences, perceptions and ethical considerations of the MIST studies. Data were obtained from semi-structured interviews and a focus group discussion. A total of 46 participants participated in MIST-ETHICS .
Three major themes emerged: experiences and perceptions of MIST, reasons for joining MIST, and ethical considerations. We found that although compensation was a motivation for participation, this was secondary to it being beneficial to self (health checks; link to health networks; building merit) and others (medical research contribution; altruism). Participants expressed varied opinions regarding the requirement of a university degree as one of the inclusion criteria for MIST.
Our study revealed widespread concerns about long-term health effects and safety. Ethical considerations, including obtaining valid informed consent and ensuring participant inclusivitiy, were deem essential. Despite some debate regarding eligibility criteria, most participants agreed that the informed consent process was robust, accompanied by a strong sense of responsibility to contribute to the greater good. We emphasize the importance of continuously gathering participants' feedback for quality control, such as improving information materials to clarify the purpose of initial phases, their contributing to later phases, and the rationale behind each selection criterion.
This manuscript is part of the clinical trials registered under ClinicalTrials.gov IDs NCT04083508 (MIST1) registered on 5 Sep 2019 and NCT05071079 (MIST2) registered on 28 July 2021. However, the manuscript pertains to a qualitative study that does not require trial registration.
泰国在过去十年的疟疾防控工作中取得了显著进展，报告病例数有所下降。然而，由于过去五年的跨境流动，泰国报告的疟疾病例有所增加。泰国疟疾感染研究（MIST）涉及故意让健康志愿者感染间日疟原虫，并评估潜在疫苗和候选药物的疗效，以了解获得性抗疟原虫保护。
本文借鉴了一项名为MIST-ETHICS的伦理和社会科学定性研究，该研究嵌入在MIST研究中。MIST-ETHICS旨在描述和理解MIST研究的经历、认知和伦理考量。数据通过半结构化访谈和焦点小组讨论获得。共有46名参与者参与了MIST-ETHICS。
出现了三个主要主题：MIST的经历和认知、参与MIST的原因以及伦理考量。我们发现，虽然补偿是参与的一个动机，但这次于对自身有益（健康检查；与健康网络的联系；积累功德）和对他人有益（医学研究贡献；利他主义）。参与者对将大学学位作为MIST纳入标准之一的要求表达了不同意见。
我们的研究揭示了对长期健康影响和安全性的广泛担忧。伦理考量，包括获得有效的知情同意和确保参与者的包容性，被认为是至关重要的。尽管在资格标准方面存在一些争议，但大多数参与者同意知情同意过程是健全的，同时伴随着为更大利益做出贡献的强烈责任感。我们强调持续收集参与者反馈以进行质量控制的重要性，例如改进信息材料以阐明初始阶段的目的、他们对后续阶段的贡献以及每个选择标准背后的理由。
本手稿是在ClinicalTrials.gov上注册的临床试验的一部分，注册号分别为2019年9月5日注册的NCT04083508（MIST1）和2021年7月28日注册的NCT05071079（MIST2）。然而，本手稿涉及一项不需要试验注册的定性研究。
