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: 2889472
• 负责人: GAIL GELLER
• 金额: $ 28.35万
• 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 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2889472
• 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 onset; 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（改编自研究者的摘要）：儿童和 由于家庭原因，未来患病风险较高的青少年 历史越来越有可能被考虑参与 疾病易感性研究随着数量的增加 鉴定出易感性突变。尽管联邦 关于涉及人类受试者的研究的知情同意的规定 明确提及将未成年人纳入研究，没有 我们已努力了解孩子对福利和福利的看法 疾病易感性研究的危害以及什么样的知情同意 过程对他们来说是有意义的。此外，人们对是否 这个健康但易患疾病的儿童群体或多或少 比其他孩子“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倾向可能 提供预防成年期疾病发作的机会；和（2） 消费者对此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研究中。 拟议的研究将探讨家庭增加的过程 成人发病的疾病风险决定让他们的孩子参与研究 遗传易感性。通过对高风险父母的访谈 对于心脏病和乳腺癌，他们的孩子在 l0 岁之间 l7，以及他们认为有影响力的医生、调查人员 将探讨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研究 （被认为在严重程度和可治疗性方面有所不同）。在 除了比较两种疾病之外，研究人员还将比较家庭 来自不同文化背景（非裔美国人、犹太人和白种人） 非犹太人）和处于不同认知发展阶段的儿童。他们 将在初次家庭访谈一年后进行后续家庭访谈 面试。他们将利用这些定性访谈的结果来 制定评估标准（针对文化和发展） 建议的同意和同意要素的充分性 儿童参与疾病易感性方案 已解决。