Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa
Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa
复制标题
DOI：
10.1191/1740774506cn150oa
复制
发表时间：
2006-01-01
期刊：
影响因子：
2.7
通讯作者：
Ranney, Megan L.
中科院分区：
文献类型：
--
作者：
Krosin, Michael T.;Klitzman, Robert;Ranney, Megan L.
工业化国家在不发达国家进行的临床试验提出了几个关键的伦理困境。一个关键的潜在问题是参与者对同意过程的误解。虽然其他报告已经开始探讨这一领域，但仍需要确定误解的具体领域。目的确定在马里，西非同意过程中的理解缺陷。方法在获得参与在两个西非村庄进行的疟疾疫苗试验的知情同意后，我们向参与者发放了一份包含9个项目的问卷，以测试他们对与其同意相关信息的理解程度。在测试了他们理解多项选择格式的能力后，100名受试者中有78人在一个村庄接受调查，85人在另一个村庄接受调查。结果参与者在理解与知情同意相关的几个概念方面存在困难：90%的受访者不理解退出标准，93%的受访者不理解研究副作用的存在，74%的受访者不理解他们参加了一项调查，而不是接受治疗。一般来说，靠近城市中心的村庄的答题率和正确率要比更偏远的村庄高得多。在城中村，有5个问题的正确率超过50%，而在农村地区，只有2个问题的正确率超过50%。本研究的潜在局限性与翻译、知情同意概念的文化差异、每个村庄之间的工作人员差异、不理解调查工具的比例以及研究探讨了参与者对同意过程的理解，但没有观察到过程本身这一事实有关。本研究阐明了发展中国家在同意过程中可能存在误解的领域。在这项研究中发现的理解程度似乎比在工业化国家进行的类似研究中发现的要高。尽管努力获得真正的知情同意，但有几个因素使其在发展中国家更具挑战性。这项研究强调需要对发展中国家的同意进行更全面的研究。这些研究最终可能有助于研究者识别、定位和解决误解的具体领域，从而改善发展中国家的知情同意程序。
Background Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding.Purpose To identify deficits in comprehension during consent processes in Mali, West Africa.Methods After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other.Results Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting.Limitations Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself.Conclusions This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of m iscom prehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.