世卫组织《临床研究同意书》模板翻译(十)

1001

If the protocol is for clinical research:

如果方案用于临床研究

Firstly, explain that there are standards/guidelines that will be followed for the treatment of their condition. Secondly, if as part of the research a biopsy will be taken, then explain whether it will be under local anesthesia, sedation or general anesthesia, and what sort of symptoms and side effects the participant should expect under each category.

首先，解释治疗他们的疾病需要遵循的标准/指南。其次，如果作为研究的一部分，要做活体组织检查，那么说明是否会行局部麻醉、镇静或全身麻醉，以及这些处理下参与者分别可能会有什么样的症状和副作用。

(Example: You will receive the treatment of your condition according to national guidelines. This means that you will be (explain the treatment). To confirm the cause of your swelling, a small sample of your skin will be taken. The guidelines say that the sample must be taken using a local anesthesia which means that we will give you an injection close to the area where we will take the sample from. This will make the area numb so that you will not feel any pain when we take the sample.)

（例如：你将根据国家指南接受治疗。这就意味着你将（说明处理）。为了确认您肿胀的原因，一小块皮肤样本将采样。指南指出采取样品必须使用局部麻醉，这就意味着在接近取样地方我们将要给您注射局麻药。这将使该区域麻木，所以我们取样时，你不会感到任何疼痛。）