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标题: 世卫组织《临床研究同意书》模板翻译(十四) [打印本页]

作者: 1001    时间: 2010-8-31 21:58
标题: 世卫组织《临床研究同意书》模板翻译(十四)

风险(Risks)

Explain and describe any possible or anticipated risks.
Describe the level of care that will be available in the event that harm does occur, who will provide it, and who will pay for it. A risk can be thought of as being the possibility that harm may occur.
Provide enough information about the risks that the participant can make an informed decision.

解释和说明任何可能的或预期的风险。,万一损害事件发生,说明现有的治疗水平,由谁提供,以及由谁出资。风险可被认为是发生危害的可能性。提供足够的有关风险信息,让参与者可以做出理性的决定。

(Example: By participating in this research it is possible that you will be at greater risk than you would otherwise be. There is, for example, a risk that your disease will not get better and that the new medicine doesn't work even as well as the old one.
If, however,
the medicine is not working and your fever does not go down in 48 hours we will give you quinine injections which will bring your fever down and make you more comfortable.

例如:参与这项研究工作你的风险可能大于你不参加的风险,例如,一个风险,你的病不会得到改善,而新的药物甚至没旧的药物有作用。不过,如果该药物没起作用,你发热48小时不止,我们将给您注射奎宁,它将给你止热,让你更舒适。


While the possibility of this happening is very low, you should still be aware of the possibility.
We will try to decrease the chances of this event occurring, but if something unexpected happens, we will provide you with______.

虽然这种情况发生的可能性非常低,你也应该意识到这种可能性。我们会尽量减少这种事件发生的机会,但如果有意外发生,我们将为您提供______。


受益(Benefits)

Mention only those activities that will be actual benefits and not those to which they are entitled regardless of participation. Benefits may be divided into benefits to the individual, benefits to the community in which the individual resides, and benefits to society as a whole as a result of finding an answer to the research question.

只提这些活动实际受益,而不是那些不论参与与否都可以得到的权益。受益可分为个人受益,个人的所在的集体受益,研究问题得到解答后整个社会的受益。

(Example: If you participate in this research, you will have the following benefits: any interim illnesses will be treated at no charge to you. If your child falls sick during this period he/she will be treated free of charge. There may not be any benefit for you but your participation is likely to help us find the answer to the research question.
There may not be any benefit to the society at this stage of the research, but future generations are likely to benefit.

例如:如果你参加这个研究,你将有以下好处:任何临时疾病将免费治疗。如果你的孩子在此时期生病他/她将被免费治疗。参加研究也可能对你的没有任何利益,但是您的参与很可能会帮助我们找到研究问题的答案。目前阶段,这项研究可能对社会没有任何利益,但很有可能造福未来的几代人。






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