Comprehension during informed consent in a less-developed country
Comprehension during informed consent in a less-developed country
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DOI：
10.1016/s0140-6736(02)11338-9
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发表时间：
2002-10-26
期刊：
影响因子：
168.9
通讯作者：
Pape, JW
中科院分区：
文献类型：
--
作者：
Fitzgerald, DW;Marotte, C;Pape, JW
关于如何确保欠发达国家的研究参与者在入组前理解同意书的实际指导方针很少。在海地的HIV-1传播研究中，参与者被要求在入学前通过同意表格内容的口头考试，及格率为12/15（80%）。15个人在与医生的一次会面中获得了信息，其中3人（20%）通过了。随后30名志愿者在三次会议中由咨询师提供信息，其中24人（80%）通过了测试。对研究参与者对同意书理解程度的正式评估应被视为欠发达国家知情同意过程中的常规步骤。
Few practical guidelines exist on how to ensure that research participants in less-developed countries understand the consent form before enrolment. In a study of HIV-1 transmission in Haiti, participants were required to pass an oral examination on the contents of the consent form with a passing score of 12/15 (80%) before enrolment. 15 individuals were given information during a single meeting with a physician, and three (20%) passed. 30 subsequent volunteers were given information by a counsellor during three meetings, and 24 (80%) passed. Formal assessment of research participants' comprehension of the consent form should be considered as a routine step in the informed consent process in less-developed countries.