Decision monitoring of adolescent research participants

不提供直接获益的前景和比最小风险略有增加的研究仅限于儿童。对让青少年参加这类研究的关切往往与他们对风险的理解以及他们参加研究的决定是否出于自愿有关。本项目的目的是描述在囊性纤维化青少年的基因转移试验中使用决策监测的经验。决策监测包括在签署知情同意书后1-4天致电26名受试者（包括16名青少年），以评估其理解和自主性。但是，不知道这个过程是否有用或有效。目前的项目正在从进行研究的七个地点的试验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），决策监测员，研究协调员和研究人员。这项研究涉及30分钟的半结构化电话采访所有愿意参与者。在7家研究中心中的6家完成了对研究人员的访谈。本项目的目标是在更大的人群中开展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.