Deliberately infecting healthy volunteers with malaria parasites: Perceptions and experiences of participants and other stakeholders in a Kenyan-based malaria infection study.
Deliberately infecting healthy volunteers with malaria parasites: Perceptions and experiences of participants and other stakeholders in a Kenyan-based malaria infection study.
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DOI：
10.1111/bioe.12781
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发表时间：
2020-10
期刊：
影响因子：
2.2
通讯作者：
Kamuya D
中科院分区：
文献类型：
--
作者：
Jao I;Marsh V;Che Chi P;Kapulu M;Hamaluba M;Molyneux S;Bejon P;Kamuya D
受控人类疟疾感染（CHMI）研究涉及在受控条件下故意用疟原虫感染健康志愿者，以研究免疫应答和/或测试药物或疫苗效力。在肯尼亚的一个研究方案中，一项经验伦理研究被纳入了CHMI研究，以探讨利益攸关方对故意感染的看法和经历及其道德影响。本定性研究的数据通过焦点小组讨论、深入访谈和非参与性观察收集。69名参与者参与其中，包括CHMI研究志愿者、社区代表和研究人员。使用QSR Nvivo 10管理数据，并在伦理学文献的指导下使用归纳演绎法进行分析。CHMI志愿者对研究程序有合理的理解。加入的决定受到研究激励、对研究机构的信任、对相关负担的评估以及支持疟疾疫苗开发的动机的影响。然而，对于志愿者、社区代表和一些研究人员来说，故意感染疟疾是一种极不寻常的研究策略。志愿人员所经历的身体、情感和社会负担或伤害往往比最初预期的要大，并随着时间的推移而波动，这与具体的程序和事件有关。尽管不太可能阻止志愿者在未来参与类似研究，但我们认为，对所涉及负担的理解水平与实际经历之间的不协调，对于社区参与、知情同意过程以及对志愿者和研究人员的持续支持来说，在道德上是相关的。我们进一步认为，CHMI研究的伦理监督应考虑到这些问题，在决定是否同意，参与和利益和伤害的平衡是合理的，在给定的背景下。
Controlled human malaria infection (CHMI) studies involve the deliberate infection of healthy volunteers with malaria parasites under controlled conditions to study immune responses and/or test drug or vaccine efficacy. An empirical ethics study was embedded in a CHMI study at a Kenyan research programme to explore stakeholders’ perceptions and experiences of deliberate infection and moral implications of these. Data for this qualitative study were collected through focus group discussions, in‐depth interviews and non‐participant observation. Sixty‐nine participants were involved, including CHMI study volunteers, community representatives and research staff. Data were managed using QSR Nvivo 10 and analysed using an inductive‐deductive approach, guided by ethics literature. CHMI volunteers had reasonable understanding of the study procedures. Decisions to join were influenced by study incentives, trust in the research institution, their assessment of associated burdens and motivation to support malaria vaccine development. However, deliberate malaria infection was a highly unusual research strategy for volunteers, community representatives and some study staff. Volunteers’ experiences of physical, emotional and social burdens or harms were often greater than anticipated initially, and fluctuated over time, related to specific procedures and events. Although unlikely to deter volunteers' participation in similar studies in furture, we argue that the dissonance between level of understanding of the burdens involved and actual experiences are morally relevant in relation to community engagement, informed consent processes, and ongoing support for volunteers and research staff. We further argue that ethics oversight of CHMI studies should take account of these issues in deciding whether consent, engagement and the balance of benefits and harms are reasonable in a given context.
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影响因子：
3
作者：
Jamrozik E;de la Fuente-Núñez V;Reis A;Ringwald P;Selgelid MJ
通讯作者：
Selgelid MJ
影响因子：
5.2
作者：
Hodgson, Susanne H.;Juma, Elizabeth;Marsh, Kevin
通讯作者：
Marsh, Kevin
影响因子：
7.7
作者：
Scott, J. Anthony G.;Bauni, Evasius;Williams, Thomas N.
通讯作者：
Williams, Thomas N.
影响因子：
3.2
作者：
Theobald, Karen A.;Ramsbotham, Joanne
通讯作者：
Ramsbotham, Joanne
影响因子：
1.6
作者：
Musschenga, AW
通讯作者：
Musschenga, AW