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B. Description of the Process 讲述过程 Describe to the participant what will happen on a step-by-step basis. It may be helpful to the participant if you use drawings or props to better illustrate the procedures. A small vial or container with a little water in it is one way of showing how much blood will be withdrawn. 逐步向参与者描述的接下来要做的事。如果您使用的图纸或道具有助于更好地阐明这个过程。一个小瓶子或装上少量水的容器是一种显示多少血将被抽的方法。 (Example: During the research you make five visits to the clinic. In the first visit, a small amount of blood, equal to about a teaspoon, will be taken from your arm with a syringe. This blood will be tested for the presence of substances that help your body to fight infections. We will also ask you a few questions about your general health and measure how tall you are and how much you weigh.
例如:在研究期间您需要5次门诊复诊。
第一次复诊,将用注射器从你的手臂抽少量的血液,约相当于1茶匙。检测血液中存在帮助您身体对抗感染的物质。我们也会问你几个关于你的健康的问题和测量你的身高体重。 At the next visit, which will be two weeks later, you will again be asked some questions about your health and then you will be given either the test drug or the drug that is currently used for malaria. As explained before, neither you nor we will know whether you have received the test or the dummy/pretend drug After one week, you will come back to the clinic for a blood test. This will involve….
两个星期后进行下次复诊,会再次询问您的健康有问题,然后你会得到试验药物或者是目前普遍使用的抗疟疾药物。正如前面所说,无论您还是我们都不知道你收到的是测试的药物还是假药物。
1周后,你要回门诊验血。这涉及...。 |