"At first, I was very afraid"-a qualitative description of participants' views and experiences in the first Human Infection Study in Malawi.
"At first, I was very afraid"-a qualitative description of participants' views and experiences in the first Human Infection Study in Malawi.
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DOI：
10.12688/wellcomeopenres.16587.2
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发表时间：
2021
影响因子：
--
通讯作者：
Manda-Taylor L
中科院分区：
文献类型：
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作者：
Mtunthama Toto N;Gooding K;Kapumba BM;Jambo K;Rylance J;Burr S;Morton B;Gordon SB;Manda-Taylor L
背景资料：人类感染研究（HIS）涉及在受控环境中故意用病原体感染健康志愿者，以了解感染并支持有效疫苗或治疗方法的开发。HIS的研究正在扩大到许多低收入和中等收入的环境，以加速疫苗的开发。鉴于实施第一次HIS研究建立实验性人类肺炎球菌携带模型的可行性，我们试图了解参与者的意见和经验。 方法：我们采用定性，描述性的方法来了解参与者的看法和经验，对HIS的参与。16名健康的成年参与者被邀请参加深入的离职面谈，讨论他们的经验，动机和关注。 结果如下：我们的研究结果表明，参与HIS研究的可能性取决于三个基本条件：参与动机，补偿和宣传。参与的动机和决定是基于利他主义、爱国主义、金钱和物质激励等原因，虽然补偿被认为是适当的，但人们对意外的研究相关风险表示担忧。建议参与者倡导团体提高认识，并在更广泛的社区教育其他人关于他的研究。 结论：参与者在马拉维的HIS经验提供了HIS研究在低收入国家和研究程序可以调整的地区可以接受的基础。
Background: Human infection studies (HIS) involve deliberately infecting healthy volunteers with a pathogen in a controlled environment to understand infection and support the development of effective vaccines or treatments. HIS research is expanding to many low and middle-income settings to accelerate vaccine development. Given the implementation of the first HIS research to establish the experimental human pneumococcal carriage model’s feasibility, we sought to understand the participant’s opinions and experiences. Methods: We used a qualitative, descriptive approach to understand participants perceptions and experiences on HIS participation. Sixteen healthy adult participants were invited to participate in in-depth exit interviews to discuss their experiences, motivations and concerns. Results: Our findings showed that the likelihood of participation in HIS research rests on three essential conditions: motivation to participate, compensation and advocacy. The motivation and decision to participate was based on reasons including altruism, patriotism, monetary and material incentives, and while compensation was deemed appropriate, concerns about unanticipated research-related risks were raised. Participant advocate groups were recommended for increasing awareness and educating others in the broader community about HIS research. Conclusions: Participants’ experiences of HIS in Malawi provide the basis of what can be acceptable in HIS research in lower-income countries and areas where study procedures could be adjusted.