Understanding of informed consent in a low-income setting: three case studies from the Kenyan coast
Understanding of informed consent in a low-income setting: three case studies from the Kenyan coast
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DOI：
10.1016/j.socscimed.2004.03.037
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发表时间：
2004-12-01
影响因子：
5.4
通讯作者：
Marsh, K
中科院分区：
文献类型：
--
作者：
Molyneux, CS;Peshu, N;Marsh, K
在我们位于肯尼亚海岸的研究单位，家长们每年都会签署同意书，允许4000多名儿童参与研究活动。儿童被招募参加从纯粹的观察性研究到新程序和药物测试的各种研究。数以千计的社区成员口头或书面同意采访，有时还同意社区研究所需的侵入性程序。虽然每一项研究和同意书都事先由独立的国家和国际委员会审查，但在本研究之前，对这些活动的研究对象的意见和理解没有记录在案。在这篇文章中，我们关注参与者对一项基于现场的研究和两项基于医院的研究的理解，这些研究都涉及血液样本。研究结果强调了在研究环境和研究之外需要考虑的一系列相互关联的问题，包括就研究进行有效沟通的概念和语言障碍，传播者(现场工作人员和护士)在同意程序中的关键和复杂的作用，影响这些过程的研究单位-社区关系的特点，以及某些问题的特殊敏感性，如血液采样。这些主题和新出现的建议预计将与在其他地方工作的研究人员的经验和见解相关，并将从中受益。(C)2004爱思唯尔有限公司。保留所有权利。
In our research unit on the Kenyan Coast, parents sign consent for over 4000 children to be involved in research activities every year. Children are recruited into studies ranging from purely observational research to the testing of new procedures and drugs. Thousands more community members consent verbally or in writing to the interviews and sometimes invasive procedures required in community-based research. Although every study and consent form is reviewed in advance by independent national and international committees, the views and understanding of the I subjects' of these activities had not been documented before this study. In this paper, we focus on participant understanding of one field-based and two hospital-based studies, all of which involve blood sampling. The findings highlight a range of inter-related issues for consideration in the study setting and beyond, including conceptual and linguistic barriers to communicating effectively about research, the critical and complex role of communicators (fieldworkers and nurses) in consent procedures, features of research unit-community relations which impact on these processes, and the special sensitivity of certain issues such as blood sampling. These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere. (C) 2004 Elsevier Ltd. All rights reserved.