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: 10226115
• 负责人: Michelle L McGowan
• 金额: $ 75.17万
• 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/10226115
• 关键词: Address; Adolescent; Adult; Age; American; Area; Behavioral; Benefits and Risks; Big Data; Child; Childhood; Clinical; Clinical Research; Collaborations; 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 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; underserved community; 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 青少年关于学习基因组研究结果的选择我们将完善现有的决定。 通过使用焦点促进明智的基因组决策的工具和流程 从现有基因组研究中招募的青少年和家长小组以及 多元化、医疗服务不足的社区，评估是否以及如何招募途径 影响参与基因组研究的感知价值、风险和收益以及回报 一旦这些材料被完善，同意青少年。 18-21岁之间、13-17岁之间同意的青少年及其父母 （对于同意的青少年可选）将被邀请使用电子设备做出选择 使用两个不同的基因组测序面板进行实际结果返回研究的决策工具。 涉及青少年、家长（如果适用）和研究团队的联合决策过程 成员将协助确认选择。 反思他们选择学习的遗传结果、影响他们选择的因素，以及 深度访谈期间的决策稳定性将被返回。 反映参与者的选择 将在返回后进行调查和访谈。 结果评估参与者的理解、感知的风险和收益、心理社会和 行为影响，以及决策后悔是否与决策稳定性相关。 在整个研究过程中与青少年偏好相关的法律、伦理和社会问题 将探讨对基因组研究结果返回的反应，包括规范 对实证研究结果以及人口层面的效用和影响的评估 这项研究的结果将有助于填补青少年的决策过程。 关于让青少年参与学习基因组学决定的文献中的关键差距 研究结果，并将有助于为青少年群体提供最佳实践。 鉴于美国医学院最近的建议，信息至关重要 遗传学可将儿童成人发病情况的结果返回给父母随时全外显子组 这项研究的结果也将有助于为成长中的人提供信息。 期望大规模地返回研究结果，需要对 从不同环境中招募的一系列人群的研究结果的道德回报。