MINORS AT-RISK OF FUTURE DISEASE: THEIR ROLE IN RESEARCH

描述（改编自研究者摘要）：儿童和 由于家庭原因，青少年未来患病的风险很高 历史越来越有可能被考虑参与 疾病易感性研究， 鉴定赋予遗传性的突变。尽管联邦 关于涉及人类受试者的研究的知情同意的条例 明确提到将未成年人纳入研究，没有 努力了解儿童对福利的看法， 疾病易感性研究的危害，以及什么样的知情同意 这个过程对他们来说是有意义的。此外，人们对是否 这群健康但易患病的儿童或多或少 比其他孩子更“脆弱”。这是一个值得研究的重要群体 因为（l）识别未来疾病的早期易感性可能 提供机会预防成年期发病;及（2） 消费者对这种测试的兴趣可能会增加， 特别是如果治疗干预是可能的或正在调查中。 拟议的研究将探讨家庭在增加 成人发病的风险决定让他们的孩子参与研究， 遗传易感性通过与风险增加的父母的访谈， 对于心脏病和乳腺癌， 和l7，以及他们认为有影响力的医生，调查人员， 将探讨参与的动机和障碍 研究这两种疾病的遗传易感性 （它们被认为在严重性和可治疗性上不同）。在 除了比较两种疾病，研究人员还将比较 来自不同文化背景（非裔美国人、犹太人和高加索人 非犹太人）和处于不同认知发展阶段的儿童。他们 将在最初的一年后进行后续的家庭访谈， 采访他们将利用这些定性访谈的结果， 制定标准（具体针对文化和发展）， 建议的同意和赞同要素是否充分 儿童参与疾病易感性协议一直是 处理。

DESCRIPTION (Adapted from the Investigator's Abstract): Children and adolescents who are at high risk of future disease because of their family history are increasingly likely to be considered for participation in disease susceptibility research as greater numbers of susceptibility-conferring mutations are identified. Despite federal regulations regarding informed consent for research involving human subjects that make explicit reference to the inclusion of minors in research, no effort has been made to understand the child's perspective on benefits and harms of disease susceptibility research, and what kind of informed consent process would be meaningful to them. Moreover, little is know about whether this healthy but disease-susceptible group of children is more or less "vulnerable" than other children. This is an important group to study because (l) identifying an early predisposition to future disease might provide an opportunity to prevent the onset of disease in adulthood; and (2) there is likely to be increasing consumer interest in such testing, especially if therapeutic interventions are possible or under investigation. The proposed study will explore the process by which families at increased risk of adult-onset disease decide to involve their children in research on genetic susceptibility. Through interviews with parents at increased risk for heart disease and breast cancer, their children between the ages of l0 and l7, and the physicians they identify as influential, the investigators will explore perceptions about the motivations and barriers to participation of children in research on genetic susceptibility to these two diseases (which are perceived as different in severity and treatability). In addition to comparing two diseases, the investigators will compare families from different cultural backgrounds (African-American, Jewish and Caucasian non-Jewish) and children at different stages of cognitive development. They will conduct follow-up family interviews one year after the initial interview. They will use the results of these qualitative interviews to develop criteria (culturally and developmentally specific) for assessing the adequacy with which recommended elements of consent and assent for children's participation in disease susceptibility protocols have been addressed.