世卫组织《临床研究同意书》模板翻译(十一）

1001

For any clinical study (if relevant):

任何临床研究(有关的)

If blood samples are to be taken explain how many times and how much in a language that the person understands. It may, for example, be inappropriate to tell a tribal villager that blood equal to a wine-glass full will be taken but it may be very appropriate to use pictures or other props to illustrate the procedure if it is unfamiliar.

如果要取血液样本，用被取样人能听懂的语言解释多少次、多少量。例如，对部落村民说取血量相当于一个葡萄酒杯，可能不合适，但如果操作过程陌生，使用图片或其他道具来说明可能非常适当。

If the samples are to be used only for this research, then explicitly mention here that the biological samples obtained during this research procedure will be used only for this research, and will be destroyed after ____ years, when the research is completed. If the tissues/blood samples or any other human biological material will be stored for a duration longer than the research purpose, or is likely to be used for a purpose other than mentioned in the research proposal, then provide information about this and obtain consent specifically for such storage and use in addition to consent for participation in the study - (see last section)
如果样本仅用于本研究，那么在这里明确指出，本研究过程中获得的生物样本将只用于此研究，当研究完成____年后会被销毁。如果组织/血液样品或任何其他的人体材料将被储存持续时间长于研究目的，或可能用于研究方案以外的其他目的，那么提供这方面的资料，除了同意参与本次研究之外，还要获得存储和使用的特定同意。（见最后一节）

(Example: We will take blood from your arm using a syringe and needle. Each time we will take about this much blood (show a spoon, vial or other small container with a small amount of water in it. In total, we will take about ……..this much blood in x number of weeks/months. At the end of the research, in 1 year, any left over blood sample will be destroyed.)

例子：我们会使用注射器和针头从你的手臂抽血。每次我们将这个多血（需显示勺子、小瓶或其它小容器并盛一些水在内。总之，在X周/月内我们将抽取大约... ... ..这么多血。在该研究结束1年后。任何剩下的血液样本将被销毁。）