Engaging adolescents in decisions about return of genomic research results

让青少年参与有关归还基因组研究结果的决定

• 批准号: 10004161
• 负责人: Michelle L McGowan
• 金额: $ 76.7万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10004161
• 关键词: Address; Adolescent; Adult; Age; American; Area; Behavioral; Benefits and Risks; Big Data; Child; Childhood; Clinical; Clinical Research; Collaborations; Communities; Conflict (Psychology); Consent; Decision Making; Disease; Ethics; Exhibits; Focus Groups; Genetic; Genetic Predisposition to Disease; Genomic medicine; Genomics; Human Genetics; Interview; Joints; Learning; Legal; Literature; Measures; Medical Genetics; Outcome; Parents; Participant; Pathway interactions; Population; Positioning Attribute; Process; Reaction; Recommendation; Regrets; Research; Research Personnel; Risk; Societies; Surveys; Testing; Time; Work; anxiety states; behavioral response; carrier status; community based participatory research; design; exome sequencing; expectation; gene panel; genome sequencing; health care service utilization; insight; medical schools; medically underserved; member; minimal risk; next generation sequencing; pediatric patients; preference; process optimization; psychosocial; recruit; reproductive; research study; response; social; tool; virtual

PROJECT ABSTRACT: The purpose of this study is to assess assenting and consenting adolescents’ choices about learning genomic research results. We will refine existing decision tools and processes to promote informed genomic decision-making through the use of focus groups with adolescents and parents recruited from an existing genomic research study and a diverse, medically-underserved community to assess whether and how recruitment pathways impact perceived value, risks, and benefits of participation in genomic research and return of personal genomic information. Once these materials have been refined, consenting adolescents between the ages of 18-21, assenting adolescents between the ages of 13-17, and their parents (optional for consenting adolescents) will be invited to make choices using an electronic decision tool for an actual return of results study using two different genome sequencing panels. A joint decision-making process involving adolescents, a parent (if applicable), and a study team member will facilitate confirmation of choices. A subset of adolescents will also be asked to reflect upon the genetic results they chose to learn, factors that impacted their choices, and decision-stability during in-depth interviews. Genomic research results will be returned that reflect the participants’ choices. Surveys and interviews will be conducted following return of results to assess participants’ understanding, perceived risks and benefits, psychosocial and behavioral impact, and whether decisional regret is associated with decisional stability. Throughout the study legal, ethical, and social issues pertaining to adolescents’ preferences and responses to return of genomic research results will be explored, including normative assessments of empirical findings as well as the population-level utility and impact of involving adolescents in the decision-making process. Findings from this study will contribute to filling a critical gap in the literature regarding engaging adolescents’ in the decision to learn genomic research results, and will help inform best practices with adolescent populations. This information is critical given recent recommendations by the American College of Medical Genetics to return children’s results for adult onset conditions to parents’ anytime whole exome or genome sequencing is performed. Findings from this study will also help inform a growing expectation to return research results on a large-scale basis, necessitating examination of ethical return of research results with a range of populations recruited from a variety of settings.

项目摘要：本研究的目的是评估同意和同意 青少年在学习基因组研究结果方面的选择。我们将完善现有决定 通过使用重点来促进知情基因组决策的工具和过程 从现有的基因组研究中招募的青少年和父母的小组 潜水员，提供医学不足的社区，以评估招聘途径是否以及如何招募途径 影响感知的价值，风险和参与基因组研究的收益和收益 个人基因组信息。一旦这些材料完善，同意的青少年 在18-21岁之间，同意13-17岁之间的青少年及其父母 （可选的同意青少年）将邀请使用电子 使用两个不同的基因组测序面板进行实际回报研究的决策工具。 涉及青少年，父母（如果适用）和学习团队的联合决策过程 成员将促进选择确认。也将要求一部分青少年 反思他们选择学习的遗传结果，影响他们选择的因素，以及 深入访谈期间的决策稳定性。基因组研究结果将归还 反映参与者的选择。返回后，将进行调查和访谈 评估参与者的理解，感知风险和利益的结果，心理社会和 行为的影响，以及决策的遗憾是否与决策稳定性有关。 在整个研究中，与青少年的偏好有关的法律，道德和社会问题 以及对基因组研究结果返回的反应，包括正常 评估经验发现以及人口级别的效用和影响的影响 青少年在决策过程中。这项研究的发现将有助于填补 关于吸引青少年学习基因组的文献中的重要差距 研究结果，并将有助于为青少年人群提供最佳实践。这 鉴于美国医学院的最新建议至关重要 遗传学将儿童的成人发作条件的结果归还给父母的任何时候 或进行基因组测序。这项研究的发现还将有助于告知不断增长的 期望大规模返回研究结果，必要的检查 从各种环境中招募的一系列人群的研究结果的道德回报。