世卫组织《临床研究同意书》模板翻译(一)

1001

模板原文见https://www.xqnmz.com/thread-14698-1-1.html。
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                                                                                                (一)

(This template is for either clinical trials or clinical research)

临床实验或临床研究模板

(language used throughout form should be at the level of a local student of class 6th/8th)

Notes to Researchers:研究者注意事项

1. Please note that this is a template developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study. The logo of the Institution must be used on the ICF and not the WHO logo.

请注明这是世卫组织伦理委员编写的模板，用于帮助研究主持人设计知情同意书(ICF)。研究主持人有必要根据本框架和特别的研究需要编写自己的(ICF)。知情同意书必须使用研究机构的图标，而不是世卫组织的图标。

2. The informed consent form consists of two parts: the information sheet and the consent certificate.

本同意书由两部分组成：资料和同意证明

3. Do not be concerned by the length of this template. It is long only because it contains guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to participants in your research.

本模板包含书写指导和解释说明，所以内容较长，在你提供给参与都的知情同意书中并不包含这些内容。

4. This template includes examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.

此模板的每节末尾包括一些可能重要的询问范例，以确保参与者理解所提供资料，这在复杂的研究中特别有用。这些只是例子和建议，研究人员可根据他们的研究修改这些问题。

5. In this template:

·square brackets indicate where specific information is to be inserted

  方括号表明这里需要插入具体的资料。

·bold lettering indicates sections or wording which should be included

  粗体字表明应该包括这一节或这些字。

·standard lettering is used for explanations to researchers only and must not be included in your consent forms. The explanation is provided in black, and examples are provided in red in italics. Suggested questions to elucidate understanding are given in black in italics.
     标准体字体仅用于向研究者说明，不要出现在同意书中。解释用黑色字，范例用红色斜体字。为表明理解，推荐给研究人员的询问用黑色斜体字。

TEMPLATE ON FOLLOWING PAGE

以下页为模板

心超

回复 1# 1001


    能否最后归纳成一个中文版的？

shenxiu2

回复 1# 1001

1。请注意这是世卫组织伦理委员编写的模板，用于帮助研究主持人设计知情同意书(ICF)。研究主持人有必要根据本框架和他们本身特定的研究需要编写自己的知情同意书(ICF)。知情同意书必须使用研究机构的图标，而不是世卫组织的图标。



3。

Do not be concerned by the length of this template. 。It is long only because it contains guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to participants in your research.

不必为此模板的长度担忧。由于本模板包含了给你的书写指导和解释，所以内容较长，这些内容并不需要加入到你所要设立和提供给研究参与者的知情同意书中。

shenxiu2

4. This template includes examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.

此模板的每节末尾包括一些可能发出的关键询问范例，以确保参与者理解所提供资料，这在复杂的研究中特别有用。这些只是例子和建议，研究人员可根据他们的研究修改这些问题。

shenxiu2

standard lettering is used for explanations to researchers only and must not be included in your consent forms. The explanation is provided in black, and examples are provided in red in italics. Suggested questions to elucidate understanding are given in black in italics.
     标准体字体仅用于向研究者说明，不要出现在同意书中。解释用黑色字，范例用红色斜体字。用来确认参与者正确理解的推荐询问用黑色斜体字。

1001

回复  1001


    能否最后归纳成一个中文版的？
心超 发表于 2010-5-17 23:58

                               
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     由于是模板， 个人的理解是错误零容忍，大家帮忙修一遍后才敢归纳成一个中文版。
这对我个人以及整个论坛都会是一个挑战，希望得到大家的支持，谢谢。

1001

shenxiu2对一些词的翻译的确准确，对此表示感谢。

This template includes examples of key questions that may be asked at the end of each section,
模板每节末尾包括一些可能要用到的关键问题的询问范例
Suggested questions to elucidate understanding are given in black in italics.
为弄清参与者是否理解，推荐给研究人员的询问范例用黑色斜体字。

这两句这样翻不知行不行？

shenxiu2

回复 7# 1001


    是的，这样就很好。