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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

基本信息

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
项目类别：
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

项目摘要

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