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

面临未来疾病风险的未成年人：他们在研究中的作用

• 批准号: 2674149
• 负责人: GAIL GELLER
• 金额: $ 28.71万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2674149
• 关键词: African American; Jewish; adolescence (12-20); age difference; breast neoplasms; caucasian American; child psychology; clinical research; counseling; culture; decision making; disease /disorder proneness /risk; family genetics; heart disorder; human subject; informed consent; interview; middle childhood (6-11); motivation; perception

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.

描述（根据调查员的摘要改编）：儿童和 由于家人而面临未来疾病的高风险的青少年 历史越来越有可能被考虑参加 疾病易感性研究是更多的 确定了敏感性的突变。尽管联邦 有关涉及人类学科的研究知情同意的法规 这明确指出了未成年人在研究中，否 已经努力了解孩子对利益的看法和 疾病易感性研究的危害，以及什么样的知情同意 过程对他们有意义。而且，对是否知道是否 这种健康但疾病的儿童群体或多或少 比其他孩子“脆弱”。这是研究的重要组 因为（l）确定对未来疾病的早期倾向可能 提供一个机会，以防止成年后疾病发作； （2） 在这种测试中，消费者的兴趣可能会增加 特别是如果可以或正在调查治疗干预措施时。 拟议的研究将探讨家庭增加的过程 成人发作疾病的风险决定让孩子参与研究 遗传敏感性。通过与父母的面试增加风险 对于心脏病和乳腺癌，他们的孩子在L0年龄 和L7，以及他们认为有影响力的医生 将探索对参与动机和障碍的看法 研究这两种疾病的遗传敏感性的研究 （在严重性和治疗性上被认为不同）。在 除了比较两种疾病，调查人员还将比较家庭 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）和处于认知发展不同阶段的孩子。他们 最初的一年后，将进行后续家庭访谈 面试。他们将使用这些定性访谈的结果来 制定标准（文化和发展特定）来评估 适当的同意和同意要素 儿童参与疾病易感性方案 解决。