Audiovisual documentation of oral consent: a new method of informed consent for illiterate populations

Audiovisual documentation of oral consent: a new method of informed consent for illiterate populations
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口头同意的视听记录:文盲人群知情同意的新方法

DOI:
10.1016/s0140-6736(02)08361-7
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发表时间:
2002
期刊:
The Lancet
影响因子:
--
通讯作者:
J. Dausset
J. Dausset
中科院分区:
--
文献类型:
--
作者:
O. Benitez;Dominique Devaux;J. Dausset

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知情同意是大多数人类研究的法律的和伦理要求,但在文盲人群中获得同意证明可能会有问题。我们在瓜拉尼印第安人项目中使用了口头同意的视听文件(录像和录音带记录和摄影),这是一种为文盲人口设计的知情同意新方法,该项目是对瓜拉尼瓜拉尼印第安人的遗传研究。我们获得了大约100名潜在参与者中42名的同意。我们认为,我们的程序允许一半以上的潜在参与者行使拒绝的自由。我们建议将这种新方法作为文盲人群临床研究的标准程序,作为书面和签署同意书的替代方法。
Informed consent is a legal and ethical requirement of most research in human beings, but obtaining proof of consent in illiterate populations can prove problematic. We used audiovisual documentation of oral consent (video and audiotape recording and photography), a new method of informed consent designed for illiterate populations, in the Guarani Indians Project, a genetic study in the Paraguayan Guarani Indians. We obtained consent from 42 of about 100 potential participants. We believe that our procedure allowed more than half the potential participants to exercise their freedom of refusal. We propose to include this new method as a standard procedure for clinical research in illiterate populations as an alternative to written and signed consent.