世卫组织《临床研究同意书》模板翻译(七)

1001

Include the following section only if the protocol is for a clinical trial:

临床实验方案包括以下栏目

实验药品的相关资料[药物名称] Information on the Trial Drug[Name of Drug]

1) give the phase of the trial and explain what that means. Explain to the participant why you are comparing or testing the drugs.

2) provide as much information as is appropriate and understandable about the drug such as its manufacturer or location of manufacture and the reason for its development.

3) explain the known experience with this drug

4) explain comprehensively all the known side-effects/toxicity of this drug, as well as the adverse effects of all the other medicines that are being used in the trial

1）告之实验阶段，并解释这意味着什么。向与参与者解释为什么你比较或测试的药物。
2）提供尽可能多的信息，让参与者恰如其分地理解药物，如制造商或制造地点和开发此药的理由。
3）解释这种药物已知的使用经验。
4）全面解释这种药物的所有已知毒副作用，以及试验中所有其他被使用药物的不良反应。

Example: The drug we are testing in this research is called ABX. It has been tested before with people who do not have malaria but who live in areas where malaria is common. We now want to test the drug on people who have malaria. This second research is called a "phase 2" trial.

范例：我们正在测试的药物在本研究被称为ABX。之前，它已经在疟疾常见地区中没患疟疾的人身上试验过。我们现在要在疟疾患者身上试验药物。第二阶段的研究被称为“2期”临床试验。

The drug ABX is made by Company C.
You should know that it has a few side effects. One of the side effects, or problems, is that you may feel tired for the first day after being given the drug. Also, 20% of the people who tried the drug in previous research experienced temporary swelling where the injection entered the skin. We know of no other problem or risks.

药物ABX是由C公司制造。您应该知道它有一些副作用。其中一个副作用是，第一天给药后你可能感到疲倦。此外，20%以前研究用过此药物的人皮肤注射部位会有临时肿胀。我们没有发现有其他的问题或风险。

Some participants in the research will not be given the drug which we are testing. Instead, they will be given the drug XYZ, the drug which is most commonly used in this region to treat malaria. There is no risk associated with that drug and no known problems. It does not, however, cure malaria as often as we would like.

有一些研究参与者将不使用我们正在测试药物。相反，他们将被给XYZ药物，本地区最常见的用于治疗疟疾的药物，这样的话不会有实验药物的风险也没已经知道的问题，当然，用它治疗疟疾也没我们预期的那么有效。