Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast.
Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast.
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认真对待社会关系：从肯尼亚海岸的疫苗试验的知情同意习惯中学到的教训。
DOI：
10.1016/j.socscimed.2008.02.003
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发表时间：
2008-09
影响因子：
5.4
通讯作者：
Molyneux, Sassy
中科院分区：
文献类型：
--
作者：
Gikonyo, Caroline;Bejon, Philip;Marsh, Vicki;Molyneux, Sassy
关键词：
个人知情同意是临床研究的关键伦理义务，但经验研究表明，关键要求往往得不到满足。在低收入环境中加强同意的共同建议包括在接触个人之前通过现有结构寻求社区成员的许可，将知情同意视为一个过程而不是单一事件，并使用问卷评估参与者的理解。在本文中，我们报告了一项定性研究，探讨社区的理解和看法的疟疾疫苗试验（MVT）在肯尼亚海岸的农村环境进行。监测和核查小组将上述所有建议纳入其信息提供过程。调查结果支持的重要性，社区一级的信息，并提供信息在几个不同的场合，然后再寻求最终的个人同意。然而，一个新出现的问题是，研究人员和社区成员之间以及社区内部的人际互动和关系，在参与者对研究的看法，他们同意或退出的决定，以及他们对研究人员的建议中起着至关重要的作用。这些关系是基于并不断测试的信息提供过程中，并通过上下文的具体关注和利益，可能难以预测，远远超出了时间表和单一的研究活动的范围。在这些研究结果的基础上，我们建议，目前的举动越来越雄心勃勃的和严格的正式标准，给予个人的信息进行平衡，更多地关注不同的社会关系，这些程序的成功应用是必不可少的。这可能有助于强调尊重社区以及人，并认识到，目前的指导方针和法规可能是一个复杂的，往往是不可预测的，不断变化的伦理困境面临的研究团队工作的“在外地”的不足反应。
Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working ‘in the field’.
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影响因子：
168.9
作者：
Fitzgerald, DW;Marotte, C;Pape, JW
通讯作者：
Pape, JW
影响因子：
3
作者：
Chuma JM;Thiede M;Molyneux CS
通讯作者：
Molyneux CS
影响因子：
5.4
作者：
Benatar, SR
通讯作者：
Benatar, SR
影响因子：
1.5
作者：
Molyneux, CS;Murira, G;Snow, RW
通讯作者：
Snow, RW
影响因子：
5.4
作者：
Molyneux, CS;Peshu, N;Marsh, K
通讯作者：
Marsh, K