世卫组织《临床研究同意书》模板翻译(二)

1001

[Informed Consent form for ____________ _______]

知情同意书

Name the group of individuals for whom this informed consent form is written. Because research for a single project is often carried out with a number of different groups of individuals - for example healthcare workers, patients, and parents of patients - it is important that you identify which group this particular consent is for.

注明知情同意书所针对的人群。因为单个研究项目往往针对不同人群开展-例如医护人员、患者和患者的父母-辨明这份同意书针对哪些特定的群体很重要。

Example: This Informed Consent Form is for men and women who attend clinic Z, and who we are inviting to participate in research on X. The title of our research project is "…………………………."

范例：本知情同意书用于Z门诊就诊的男性和女性，以及我们邀请加入X研究的人，我们研究项目的题名是“... ... ... ... ...”。  

  

You may provide the following information either as a running paragraph or under headings as shown below.

你可以用一个连续的段落或如下所示在标题下提供以下信息。

[Name of Principal Investigator]    [项目主持人]

[Name of Organization]                  [研究机构]

[Name of Sponsor]                          [发起人]          

[Name of Proposal and version]    [方案和版本]

This Informed Consent Form has two parts:

• Information Sheet (to share information about the research with you)
• Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

本知情同意书有两部分：•知情告知（与您分享研究资料）•同意证明（签名用，如果您同意参加）

您将获得一份完整的知情同意书副本

1001

发帖会被自动编排，无法从编辑窗口修改，帖子的版面有点乱，抱歉!

shenxiu2

[Name of Principal Investigator]    [项目主持人]

[Name of Organization]                  [研究机构]

[Name of Sponsor]                          [发起人]   是资助单位吗？      

[Name of Proposal and version]    [方案和版本]





This Informed Consent Form has two parts:

Information Sheet (to share information about the research with you)
Certificate of Consent (for signatures if you agree to take part)
You will be given a copy of the full Informed Consent Form

本知情同意书有两部分：•知情告知（与您分享研究资料）•同意证明（签名用，如果您同意参加）

您将获得一份完整的知情同意书副本

shenxiu2

回复 2# 1001


    你所问的Clinic 和 version to翻得没错。

1001

请求高人指点!

1. Name of Sponsor译为资助单位比较符合国外的说法，一般是谁发起谁出资。国内习惯说某某公司发起的某某研究，似乎是有意要避免提到钱的问题。

2.  Information Sheet (to share information about the research with you)
Certificate of Consent (for signatures if you agree to take part)
You will be given a copy of the full Informed Consent Form
原文把参与者放在了第一人称的位置，在大陆好象习惯用第三人称来说明这一点。比如：“您将获得一份知情同意书的副本”，“参与者将获得一份知情同意书的副本”，这两种译法的应该取谁？

3. Proposal and Version 方案和版本
从翻译的角度来说没有任何问题，
但实际工作它是指的什么，比如方案是指双盲，对照么？那版本又是指得什么？会是GCP中的临床几期么？

1001

3. Proposal and Version
应该是指研究任务书和立项批文。