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标题: 世卫组织《临床研究同意书》模板翻译(十三） [打印本页]

作者: 1001 时间: 2010-8-22 12:23
标题: 世卫组织《临床研究同意书》模板翻译(十三）
本帖最后由 1001 于 2010-8-22 12:37 编辑

持续时间(Duration)

Include a statement about the time commitments of the research for the participant including both the duration of the research and follow-up, if relevant.

给参与者承诺研究时间，包括研究持续时间和相关的随访时间。

(Example: The research takes place over ___ (number of) days/ or ___ (number of) months in total. During that time, it will be necessary for you to come to the clinic/hospital/health facility _______(number of) days , for ____ (number of) hours each day. We would like to meet with you three months after your last clinic visit for a final check-up.

（例如：研究总共进行___（数目）天/或___（数目）月。在此期间，您将有必要来到诊所/医院/医疗机构_______(数目）天，每一天____（数目）小时。最后一次门诊随访结束过3个月之后，我们将为你作最终的检查

In total, you will be asked to come 5 times to the clinic in 6 months. At the end of six months, the research will be finished.)
总而言之，要求你6个月来5次门诊。6个月末，该研究将完成。

副作用(Side Effects)

Potential participants should be told if there are any known or anticipated side effects and what will happen in the event of a side effect or an unexpected event.

有意参加者应被告知，是否有任何已知或可能的副作用，万一发生了副作用或意外事件会怎么样。

(Example: As already mentioned, this drug can have some unwanted effects. It can make you tired and it can cause some temporary swelling around the place where the injection goes into your arm. It is possible that it may also cause some problems that we are not aware of.
However, we will follow you closely and keep track of any unwanted effects or any problems. We may use some other medicines to decrease the symptoms of the side effects or reactions. Or we may stop the use of one or more drugs.
If this is necessary we will discuss it together with you and you will always be consulted before we move to the next step.)

例如：正如已经提到的，这种药物可能有一些不良反应。它可以使你疲劳，并且造成你胳臂注射点周围临时肿胀。它也很可能导致一些我们不知道的问题。不过，我们会密切随访您，并记录下任何不良反应或任何问题。我们可以使用一些其他药物，以减少副作用或反应。我们也可能会停止一个或多个使用药物。如果有必要，我们将与您一起讨论，进入到下一个步骤前我们总是会咨询你。

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