Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya
Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya
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DOI：
10.1186/1472-6939-11-13
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发表时间：
2010-07-15
影响因子：
2.7
通讯作者：
Molyneux, Sassy S.
中科院分区：
文献类型：
--
作者：
Marsh, Vicki M.;Kamuya, Dorcas M.;Molyneux, Sassy S.
背景：社区参与对解决国际生物医学研究的伦理挑战的潜在贡献得到了很好的描述，但社区参与在实践中发展的经验相对较少。本文借鉴了肯尼亚一项遗传队列研究中有关社区参与和知情同意的经验，有助于理解社区参与在支持伦理研究实践方面的优势和挑战，重点关注沟通问题、实地工作人员在实地“做伦理”方面的作用以及社区咨询的挑战。方法：研究结果基于行动研究方法，包括对社区参与文件的分析以及密切参与其制定和实施的作者的观察。定性和定量内容分析已用于记录工作人员会议和培训、与24名社区领导人的会议、40次大型公众会议和70次小型社区小组会议。使用专题框架方法分析了六个社区代表团体的有目的抽样的会议纪要。结果：现场工作人员描述了对研究的误解、招聘的感知压力和解释研究的挑战。在磋商期间，领导人表示支持镰状细胞病的研究和筛查。在社区会议上，对研究有一种共同的解释，即医疗保健。担忧集中在不熟悉的程序上。在向领导和社区成员解释了研究程序后，很少有人问关于样本出口或样本存档以供未来研究的问题。结论：社区参与使研究人员能够在研究过程中考虑到工作人员和社区的意见和问题，并调整信息和方法来应对新出现的伦理挑战。开展知情同意工作的实地工作人员面临着复杂的问题，他们的理解、态度和沟通技巧是影响道德实践的关键因素。社区协商是一个具有挑战性的概念，难以付诸实践，这说明了评估信息需求的复杂性，以及适合某项研究的审议水平。
Background: The potential contribution of community engagement to addressing ethical challenges for international biomedical research is well described, but there is relatively little documented experience of community engagement to inform its development in practice. This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contribute to understanding the strengths and challenges of community engagement in supporting ethical research practice, focusing on issues of communication, the role of field workers in 'doing ethics' on the ground and the challenges of community consultation.Methods: The findings are based on action research methods, including analysis of community engagement documentation and the observations of the authors closely involved in their development and implementation. Qualitative and quantitative content analysis has been used for documentation of staff meetings and trainings, a meeting with 24 community leaders, and 40 large public and 70 small community group meetings. Meeting minutes from a purposive sample of six community representative groups have been analysed using a thematic framework approach.Results: Field workers described challenges around misunderstandings about research, perceived pressure for recruitment and challenges in explaining the study. During consultation, leaders expressed support for the study and screening for sickle cell disease. In community meetings, there was a common interpretation of research as medical care. Concerns centred on unfamiliar procedures. After explanations of study procedures to leaders and community members, few questions were asked about export of samples or the archiving of samples for future research.Conclusions: Community engagement enabled researchers to take account of staff and community opinions and issues during the study and adapt messages and methods to address emerging ethical challenges. Field workers conducting informed consent faced complex issues and their understanding, attitudes and communication skills were key influences on ethical practice. Community consultation was a challenging concept to put into practice, illustrating the complexity of assessing information needs and levels of deliberation that are appropriate to a given study.