世卫组织《临床研究同意书》模板翻译(九)

1001

A. Unfamiliar Procedures

This section should be included if there may be procedures which are not familiar to the participant.

如果有的过程参与者可能不熟悉，本节应包括在内。

If the protocol is for a clinical trial:

如果是临床实验方案

1) involving randomization or blinding, the participants should be told what that means and what chance they have of getting which drug (i.e. one in four chances of getting the test drug).

1）涉及随机或盲法研究，参与者应被告知这是什么意思，他们在什么情况下接受什么药物（例如：四分之一机会接受测试药物）。

Example:. Because we do not know if the new malaria drug is better than the currently available drug for treating malaria, we need to compare the two. To do this, we will put people taking part in this research into two groups.
The groups are selected by chance, as if by tossing a coin.

例如：因为我们不知道新的抗疟疾药物是否优于现有治疗疟疾的药物，我们需要比较二者。要做到这一点，我们让参与这项研究的人分为两个组。随机挑选组员，就象掷硬币。

Participants in one group will be given the test drug while participants in the other group will be given the drug that is currently being used for malaria. It is important that neither you nor we know which of the two drugs you are given. This information will be in our files, but we will not look at these files until after the research is finished. This is the best way we have for testing without being influenced by what we think or hope might happen. We will then compare which of the two has the best results.

一组参加者将被给予测试药物，而另一组参与者会获得目前普遍使用的疟疾药物。重要的是，你我都不知道两种药物中你接受的是哪一种。我们将这些资料用文件保存，直到研究完成后我们才会看这些文件。这是我们测试的最好方式，它不会被我们认为或希望的结果所影响。然后，我们将比较这两者中哪个有最佳的效果。

The healthcare workers will be looking after you and the other participants very carefully
during the study.
If we are concerned about what the drug is doing , we will find out which drug you are getting and make changes. If there is anything you are concerned about or that is bothering you about the research please talk to me or one of the other researchers.

在研究过程中，医护人员将非常仔细地照顾你和其他参与者。如果我们担心药物的作用，我们会找出你接受的是哪种药物并进行更改。如果您有任何担心或被研究烦扰，请告诉我或其他研究者。

2) involving an inactive drug or placebo, it is important to ensure that the participants understand what is meant by a placebo or inactive drug.

2）涉及一个无作用的药物或安慰剂时，要确保参加者明白安慰剂或者无作用的药物的意义，这很重要。

(Example: A placebo or inactive medicine looks like real medicine but it is not. It is a dummy or pretend medicine. It has no effect on a person because it has no real medicine in it. Sometimes when we want to know whether a new medicine is good, we give some people the new medicine and some people the pretend or dummy medicine. For the research to be good, it is important that you do not know whether you have been given the real medicine or the pretend or dummy medicine.
This is one of the best ways we have for knowing what the medicine we are testing really does.

例如：一个安慰剂或无作用的药看起来像真正的药物，但事实并非如此。这是一个假的或伪装的药物。它对一个人并没有影响，因为在它里面没有真正的药品。有时，当我们想知道新药是否好，我们给一些人新药另一些人假药或伪装的药。为了做好研究，你不知道你是否得到真正的药物或假药是重要的。要想知道测试药物的真正作用，这是现有的最好方法之一，。

3) which may necessitate a rescue medicine, then provide information about the rescue medicine or treatment such as what it is and the criterion for its use. For example, in pain trials, if the test drug does not control pain, then intravenous morphine may be used as a rescue medicine.

3）可能需要补救药品，然后提供有关补救药物或治疗的资料，诸如它是什么和使用标准。例如，在疼痛实验，如果测试药物无法控制疼痛，然后静脉注射吗啡可作为补救药物。

(Example: If we find that the medicine that is being used does not have the desired effect, or not to the extent that we wish it to have, we will use what is called a “rescue medicine.” The medicine that we will use is called QRS and it has been proven to control pain. If you find that the drug we are testing does not stop your pain and it is very uncomfortable for you, we can use the rescue medicine to make you more comfortable.)

例如：如果我们发现，正在使用的药物没有收到预期的效果，或没达到我们希望的程度，我们将使用叫做“补救药品”的药，我们使用的药物被称为QRS，它已被证明可以控制疼痛。如果您发现该药物，我们正在测试并不能阻止你的痛苦，让你非常不舒服，我们可以使用补救药让你更舒适。

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如果您发现该药物，我们正在测试并不能阻止你的痛苦

“如果您发现我们正在测试的该药物，并不能阻止你的痛苦”会比较通顺。