Engaging Adolescents in Decisions About Return of Genomic Research Results

Cincinnati Children's Hospital Medical Center

Status: Active, not recruiting

Conditions: Genetic Testing; Genetic Screening; Shared Decision Making; Genetic Change; Adolescent; Knowledge, Attitudes, Practice

Treatments: Genetic: Electronic Decision Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04481061

5R01HG010166-02

Details and patient eligibility

About

Recent recommendations to return children's results for adult-onset conditions to parents anytime whole exome or genome sequencing is performed, as well as growing expectations to return research results to participants on a large-scale basis, mean adolescents will increasingly be engaged in assenting (<age 18) and consenting (>age 18) to return of genomic research results. There is an urgent need to understand adolescents' informational preferences and to create ethically informed, scalable processes that empower adolescents from diverse backgrounds to participate in the decision-making process about learning genomic results. This research will provide important insights into adolescents' choices, as well as the ethical, legal and societal implications of engaging adolescents in making choices about learning genomic results in genomic research and community-based research settings.

Full description

The purpose of this study is to assess assenting and consenting adolescents' choices about learning genomic research results. The investigator 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.

Enrollment: 787 patients

Sex: All

Ages: 13 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Assenting adolescents (13-17 years)
• Consenting adolescents (18-21 years)
• Parent / legal guardian of assenting or consenting adolescent
• Ability to participate in remote study visits, if applicable

Exclusion criteria

• Those who do not meet inclusion criteria
• Those who do not communicate in English
• Individuals with developmental disabilities that interfere with their ability to make independent decisions

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

787 participants in 1 patient group

Decision Making About Genetic Results

Other group

Description:

Adolescents between 13-21 and parent (if applicable) will make decisions about learning results using an electronic decision tool. Results that match their choices will be returned.

Treatment:

Genetic: Electronic Decision Tool