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

描述(改编自《调查员摘要》)：儿童和 因家庭原因而面临未来疾病高危的青少年 历史越来越有可能被考虑参与到 疾病易感性研究随着更多的 确定了导致易感性的突变。尽管联邦政府 关于人类受试者研究的知情同意的规定 明确提到将未成年人纳入研究，不 已作出努力了解儿童对福利和 疾病易感性研究的危害，以及什么样的知情同意 这一过程对他们来说将是有意义的。此外，几乎不知道是否 这群健康但易患疾病的儿童或多或少 比其他孩子更“脆弱”。这是一个需要研究的重要群体 因为(L)识别出对未来疾病的早期易感性可能 提供机会预防成年后发病；及(2) 消费者对这类测试的兴趣可能会越来越大， 特别是如果治疗干预是可能的或正在调查中的话。 拟议的研究将探索家庭在增加的过程中 成人发病的风险决定让他们的孩子参与研究 遗传易感性。通过采访风险较高的父母 对于心脏病和乳腺癌，他们的孩子在10岁之间 和L7，以及他们认为有影响力的医生，调查人员 将探索人们对参与动机和障碍的看法 儿童对这两种疾病的遗传易感性的研究 (它们在严重性和可治疗性方面被认为是不同的)。在……里面 除了比较两种疾病，研究人员还将比较家庭 来自不同的文化背景(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 面试。他们将利用这些定性面试的结果来 制定(文化和发展方面的)评估标准 建议的同意和同意的要素是否充分 儿童参与疾病易感性方案一直是 地址。

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.