世卫组织《临床研究同意书》模板翻译(三)

1001

PART I: Information Sheet

第一部分，知情告知

简介(Introduction)

Briefly state who you are and explain that you are inviting them to participate in the research you are doing. Inform them that they may talk to anyone they feel comfortable talking with about the research and that they can take time to reflect on whether they want to participate or not. Assure the participant that if they do not understand some of the words or concepts, that you will take time to explain them as you go along and that they can ask questions now or later.

简要说明你是谁，表明你正在邀请他们参加你进行的研究。告诉他们，他们可以跟任何他们感到放心的人谈论这项研究，可以花时间仔细思考是否参加。向参加者保证，如果一些词或概念他们不理解，你开展研究的同时会抽出时间解释，他们可以现在或以后提问。

Example: I am X, working for the Y Research Institute. We are doing research on Z disease, which is very common in this country. I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.

范例：我是X，为Y研究机构工作。我们正在研究Z疾病，这是在我国家很常见的疾病。我将为你提供信息，并邀请您参加本研究。你不一定要今天做出决定，在你决定前，你可以向任何你觉得放心的人谈论。

There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain.
If you have questions later, you can ask them of me, the study doctor or the staff.)

在我们讲解资料时，有不明白之处，请让我停下来，我会用一些时间来解释。如果以后你有问题，你可以问我、研究医生或工作人员。

shenxiu2

Feel Comfortable with ----在这儿 我觉得用“信任”会比较恰当。
As you go along---当你给他讲解的时候，。。。。
As we go through....“当我们一起看这些资料时”，或“当我给你讲解这些资料时。。。）
study doctor----做研究的医生