Decision monitoring of adolescent research participants

没有提供直接益处的前景，并且比最小风险略有增加的研究被限制在儿童中。让青少年参加这类研究往往与他们对风险的理解以及他们是否自愿决定参与有关。这个项目的目的是描述在患有囊性纤维化的青少年的基因转移试验中使用决策监测的经验。决策监测包括在同意书签署后1-4天给26名受试者(包括16名青少年)打电话，以评估他们的理解和自愿程度。然而，目前还不知道这一过程是否有用或有效。目前的项目是在进行研究的七个地点从这次试验的参与者那里收集初步信息。这些参与者包括受试者、他们的父母(如果是青少年)、决策监督员、研究协调员和调查人员。这项研究包括对所有有意愿的参与者进行30分钟的半结构化电话采访。在7个研究地点中，有6个完成了与研究人员的访谈。该项目的目标将是开发一项在更大人口中进行决策监测的前瞻性研究。

Research that does not offer the prospect of direct benefit and has more than a minor increase over minimal risk is restricted in children. The concerns about enrolling adolescents in such research are often related to their comprehension of the risks and whether their decision to participate is voluntary. The objective of this project is to describe the experience of using decision monitoring in a gene transfer trial in adolescents with cystic fibrosis. Decision monitoring consisted of a phone call to 26 subjects (including 16 adolescents) 1-4 days after the consent form was signed to assess their comprehension and voluntariness. However, it is not known if this process was useful or effective. The current project is collecting preliminary information from the participants in this trial at the seven sites where the study was conducted. These participants included the subjects, their parents (if adolescents), the decision monitors, the research coordinators, and the investigators. The study involves 30-minute semi-structured telephone interviews with all willing participants. Interviews had been completed with study personnel at 6 of 7 research sites. The goal of this project will be to develop a prospective study of a decision monitoring in a larger population.