Engaging adolescents in decisions about return of genomic research results
Institution: Cincinnati Childrens Hospital Medical Center
FOA Number: PA-18-345
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.
FUNDING AGENCY:
Funder:
NIH
Institute:
NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Funding Type:
R01
Project Number:
R01HG010166
Start Date:
Sep 1, 2019
End Date:
Jun 30, 2024
PROJECT TERMS:
Adolescent, Adult, Age, American, anxiety states, Area, Behavioral, behavioral response, Benefits and Risks, Big Data, carrier status, Child, Childhood, Clinical, Clinical Research, Collaborations, Communities, community based participatory research, Conflict (Psychology), Consent, Decision Making, design, Disease, Ethics, Exhibits, exome sequencing, expectation, Focus Groups, Genetic, Genetic Predisposition to Disease, genome sequencing, Genomic medicine, Genomics, health care service utilization, Human Genetics, insight, Interview, Joints, Learning, Legal, Literature, Measures, Medical Genetics, medical schools, medically underserved, member, minimal risk, next generation sequencing, Outcome, Parents, Participant, Pathway interactions, pediatric patients, Population, Positioning Attribute, preference, Process, process optimization, psychosocial, Reaction, Recommendation, recruit, Regrets, reproductive, Research, Research Personnel, research study, response, Risk, social, Societies, Surveys, Testing, Time, tool, virtual, Work