世卫组织《临床研究同意书》模板翻译(五)
本帖最后由 1001 于 2010-6-8 19:51 编辑研究干预的种类(Type of Research Intervention)Briefly state the type of intervention that will be undertaken. This will be expanded upon in the procedures section but it may be helpful and less confusing to the participant if they know from the very beginning whether, for example, the research involves a vaccine, an interview, a biopsy or a series of finger pricks. 简述将应用的干预种类，这在研究过程这一节中会详述，如果参与者从一开始就知道干预种类，例如，接种疫苗、会诊、活检或一系列地扎手指采血，可能有助于减少他们的困惑。Example: This research will involve a single injection in your arm as well as four follow-up visits to the clinic. 范例：这项研究涉及在您手臂上单次注射以及4次门诊随访。
参与者选择(Participant selection)State why this participant has been chosen for this research. People often wonder why they have been chosen to participate and may be fearful, confused or concerned.说明为什么参与者被入选这一研究。人们常常想知道为什么他们被选，并可能感觉恐惧、迷惑或担心。Example:We are inviting all adults with malaria who attend clinic Z to participate in the research on the new malaria drug
范例：我们邀请所有Z门诊患疟疾的成年人加入关于新疟疾药物的研究。Example of question to elucidate understanding: Do you know why we are asking you to take part in this study? Do you know what the study is about?用于阐明理解的询问例句：你知道为什么我们要你加入这项研究么？你知道这项研究是关于什么的么？ 简述将进行的干预种类，这在研究过程这一节中会详述，但是，如果参与者从一开始就知道干预种类，例如，接种疫苗、会诊、活检或一系列地扎手指采血，可能有助于减少他们的困惑。
参与者的遴选
说明为什么参与者被遴选参加这一研究。人们常常会疑惑为什么他们被选中，并可能因此感觉恐惧、迷惑或担心。
我们邀请所有Z门诊患疟疾的成年人加入这项新疟疾特效药的研究。
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