Assessment of Parents'/Guardians' Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia.
Assessment of Parents'/Guardians' Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia.
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DOI：
10.1177/1556264618767780
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发表时间：
2018-07
期刊：
影响因子：
--
通讯作者：
Heitman E
中科院分区：
文献类型：
--
作者：
Ossemane EB;Moon TD;Sacarlal J;Sevene E;Kenga D;Gong W;Heitman E
参与者对研究方案的关键要素的理解对于他们在研究中的伦理注册是至关重要的。持续的参与应该建立在持续的理解和同意的基础上，这需要高度的回忆。许多障碍会妨碍对研究方案信息的充分理解。本研究的目的是评估参加莫桑比克临床研究的儿童的父母/监护人对知情同意要素的理解和一天回忆。我们根据研究的知情同意文件开发了一个10个问题的测试。我们要求参与者在阅读知情同意文件后立即回答问题，并在第二天再次回答问题。在入学时没有表现出良好或合理理解的参与者再次提供信息作为复习。总体而言，较高的初步理解率表明，对知情同意程序的关注可以使莫桑比克人在知情的情况下自愿参与临床试验。
Participants’ understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study´s aim was to evaluate the comprehension and one-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study’s informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans’ informed, voluntary participation in clinical trials.
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影响因子：
2.5
作者：
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通讯作者：
Mehendale, Sanjay M.
影响因子：
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作者：
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通讯作者：
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