志愿者专区 / 临床试验常识

受试者须知:什么是知情同意?

知情同意是在了解有关临床研究的细节和背景之后决定是否参加试验作为受试者的过程。您同意作为志愿者之前必需清楚地了解真实的研究过程以及可能对您产生的影响。

知情同意开始时研究人员会向您解释研究的具体过程、您可能经历的程序如需要做什么检验、怎样用药等、可能的受益和风险,以及作为一名研究志愿者的权利。

如果您的问题已经得到答复,并且您已经完全了解有关研究试验的真实情况并决定参加试验,就需要签署一份“知情同意书”。请仔细阅读知情同意书,如果您有任何问题,请向研究人员询问。在决定前,与家庭成员、朋友或您的医生商量也是很有帮助的。

What is informed consent?

Informed consent is the process oflearning important facts about the research study before you decide whether ornot to volunteer. If you agree to volunteer, it should be based on a clearunderstanding of what will take place in the study and how it might affect you.

Informed consent begins when theresearch staff explains the study to you. These facts include details about thestudy, tests or procedures you may receive, the benefits and risks that couldresult, and your rights as a research volunteer.

Once your questions have been answered andyou fully understand the facts about the research study, you will be asked tosign an “informed consent form.” You should take your time when you read theinformed consent form. If you have any questions, ask the research staff toexplain. It may be helpful to talk with family members, friends, or your healthcare providers before you make a decision.

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