Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.
Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.
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DOI：
10.1371/journal.pone.0157056
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发表时间：
2016
期刊：
影响因子：
3.7
通讯作者：
Addissie T
中科院分区：
文献类型：
--
作者：
Abay S;Addissie A;Davey G;Farsides B;Addissie T
知情同意是涉及人类参与者的生物医学研究的一个关键组成部分。然而，在识字率低和资源有限的情况下，获得知情同意是一项挑战。快速伦理评估（REA）可用于在给定研究社区内简化知情同意信息。本研究旨在探讨在知情同意过程中社会、文化和宗教因素对HPV血清型流行率研究的影响。2013年7月至8月，在埃塞俄比亚北方的Adigudom和Mynebri Kebeles进行了一次定性的社区REA。由多学科团队使用与母研究相关的知情同意组成部分有关的开放式问题收集数据。该团队与主要知情人和社区成员进行了一对一的深入访谈（IDI）和焦点小组讨论（FGD），以收集基于研究主题的数据。磁带记录的数据用Tigrigna转录，然后翻译成英语。数据进行了分类和主题分析，使用开放编码和内容分析的基础上预先定义的主题。REA研究揭示了一些与拟议研究有关的社会文化问题。记录显示，社区对健康研究、参与者权利和宫颈癌的认识较低。提供阴道样本进行测试被认为是非常尴尬的，而提供血液样本使参与者担心他们可能会在没有治疗可能性的情况下得到结果。对于拟定的研究，口头同意优于书面同意。这种快速的道德评估揭示了重要的社会文化问题，这些问题可能会成为知情决策的障碍。这些发现对于信息表的上下文修改以及指导拟议研究的最佳知情同意过程非常重要。两者都可能使受试者更好地理解知情同意书，从而遵守研究。
Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the study.