Ethical considerations around volunteer payments in a malaria human infection study in Kenya: an embedded empirical ethics study.
Ethical considerations around volunteer payments in a malaria human infection study in Kenya: an embedded empirical ethics study.
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肯尼亚疟疾人类感染研究中志愿者支付的伦理考虑：一项嵌入式经验伦理研究。
DOI：
10.1186/s12910-022-00783-y
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发表时间：
2022-04-20
影响因子：
2.7
通讯作者：
Kamuya, Dorcas
中科院分区：
文献类型：
--
作者：
Chi, Primus Che;Owino, Esther Awuor;Jao, Irene;Bejon, Philip;Kapulu, Melissa;Marsh, Vicki;Kamuya, Dorcas
人类感染研究（HIS）已成为一种重要的研究方法，有可能快速跟踪全球传染病疫苗和治疗的发展，包括在低资源环境中。考虑到许多HIS涉及的高水平负担，特别是长期居住和生物采样要求，确定提供足够补偿但避免“不适当”诱导参与的研究支付水平可能具有挑战性。通过这种嵌入式伦理研究，涉及97名健康志愿者和其他研究利益相关者在肯尼亚的疟疾HIS计划，并使用深入访谈，焦点小组讨论和观察期间和之后的疟疾HIS，我们给出了一个接地的道德问题出现在这种情况下的研究付款。虽然谨慎的社区，国家，国际科学和伦理审查过程意味着严重伤害的风险极不可能，但加入HIS的动机水平可能会引起对研究费用过高的担忧。特别重视的是可靠性，而不是水平，在这种情况下，在生存生计是常见的学习支付。研究志愿者在招募时通常清楚研究目的，并且这种知识在一年后保留下来，尽管大多数人报告说在招募时经历了比预期更多的负担。严格的研究筛选程序、对志愿者的定期临床和实验室监测以及在预定终点及时进行抗疟治疗表明，严重伤害的风险极不可能发生。志愿者试图隐瞒症状，希望延长住院时间和增加研究费用;志愿者做出损害重要家庭关系和个人价值观的决定，这些都引起了伦理问题。我们的研究结果支持这样一种解释，即尽管研究志愿者热衷于加入研究以获得现金支付，但他们也关注研究的其他特征和一般临床研究景观，包括与研究参与相关的风险水平。总体而言，我们的分析表明，研究支付中出现的伦理问题可以通过实际措施来解决，取决于减轻负担和加强沟通，为研究政策和规划提出重要问题。在线版本包含补充材料，可通过10.1186/s12910-022-00783-y获得。
Human Infection Studies (HIS) have emerged as an important research approach with the potential to fast track the global development of vaccines and treatments for infectious diseases, including in low resource settings. Given the high level of burdens involved in many HIS, particularly prolonged residency and biological sampling requirements, it can be challenging to identify levels of study payments that provide adequate compensation but avoid ‘undue’ levels of inducement to participate. Through this embedded ethics study, involving 97 healthy volunteers and other research stakeholders in a malaria HIS programme in Kenya, and using in-depth interviews, focus group discussions and observations during and after a malaria HIS, we give a grounded account of ethical issues emerging in relation to study payments in this setting. While careful community, national, international scientific and ethics review processes meant that risks of serious harm were highly unlikely, the levels of motivation to join HIS seen could raise concerns about study payments being too high. Particular value was placed on the reliability, rather than level, of study payment in this setting, where subsistence livelihoods are common. Study volunteers were generally clear about the study aims at the point of recruitment, and this knowledge was retained over a year later, although most reported experiencing more burdens than anticipated at enrolment. Strict study screening procedures, regular clinical and laboratory monitoring of volunteers, with prompt treatment with antimalarial at predetermined endpoints suggested that the risks of serious harm were highly unlikely. Ethical concerns emerged in relation to volunteers’ attempts to conceal symptoms, hoping to prolong residency periods and increase study payments; and volunteers making decisions that compromised important family relationships and personal values. Our findings support an interpretation that, although study volunteers were keen to join the study to access cash payments, they also paid attention to other features of the study and the general clinical research landscape, including levels of risk associated with study participation. Overall, our analysis shows that the ethical concerns emerging from the study payments can be addressed through practical measures, hinged on reducing burdens and strengthening communication, raising important issues for research policy and planning. The online version contains supplementary material available at 10.1186/s12910-022-00783-y.
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影响因子：
2.2
作者：
Jao I;Marsh V;Che Chi P;Kapulu M;Hamaluba M;Molyneux S;Bejon P;Kamuya D
通讯作者：
Kamuya D
影响因子：
--
作者：
Gordon SB;Rylance J;Luck A;Jambo K;Ferreira DM;Manda-Taylor L;Bejon P;Ngwira B;Littler K;Seager Z;Gibani M;Gmeiner M;Roestenberg M;Mlombe Y;Wellcome Trust CHIM workshop participants
通讯作者：
Wellcome Trust CHIM workshop participants
影响因子：
2.7
作者：
Devine, Eric G.;Waters, Megan E.;Ciraulo, Domenic A.
通讯作者：
Ciraulo, Domenic A.
影响因子：
4
作者：
Gale NK;Heath G;Cameron E;Rashid S;Redwood S
通讯作者：
Redwood S
影响因子：
9.3
作者：
Gbesemete, D.;Barker, M.;Read, R. C.
通讯作者：
Read, R. C.