Randomized Trial of Consent Interventions for NIH Whole Exome and Whole Genome Sequencing Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- B
研究概览
简要总结
Background:
The purpose of this study is to investigate the process of consenting participants to whole exome/genome sequencing and its outcomes. It is unknown how best to consent people to this new technology. NO GENOME SEQUENCING IS OFFERED AS PART OF THIS STUDY. This protocol is a companion to other NIH studies that involve genomic sequencing. Participants must be enrolled in a parent NIH study that is collaborating on this consent study to be eligible. Currently this involves only one NIH study.
Objectives:
- To learn the best way to help participants understand sequencing, so they can decide whether to join studies that use it.
Eligibility:
- Adults at least 18 years old who are enrolled in a National Institutes of Health (NIH) study that uses WES/WGS.
- Adults at least 18 years old whose children are enrolled in an NIH study that uses WES/WGS.
Design:
- Participants will take part in the study either in person or over the phone.
- Participants will review two sequencing consent forms with a genetic counselor.
- Before and after meeting with the counselor, participants will answer several questions about sequencing. Each questionnaire will take about 15 minutes.
- Six weeks later, participants will answer questions about sequencing. This will take about 15 minutes.
详细描述
Consent to participant in studies that include whole exome and whole genome sequencing (WES/WGS) studies and to receive results present challenges to achieving informed consent due to the scope, depth and uncertainty of the information. NIH Intramural studies increasingly involve WES/WGS to identify elusive primary variants. This umbrella protocol aims to compare an evidence-based consent for WES/WGS to a standard consent in collaboration with ongoing and future NIH studies. An equivocal hypothesis will be tested to evaluate whether informed choice and perceptions of uncertainty differ between two consent
groups. A mixed-methods design is proposed that starts with a qualitative mental-model pilot
study to revise an expert opinion consent intervention by integrating lay-person response
preferences. Following development of this evidence-based intervention, a randomized two- factor design will be used for a quantitative survey study conducted in conjunction with a
number of NIH studies conducting WES/WGS to test for differences between two consent
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
B
时间窗: Ongoing
To quantitatively assess changes in understanding, perceptions of uncertainty and informed choice between the two consent interventions, assuming equivalency.
D
时间窗: Ongoing
To compare the content, dialogue and time spent in the consent discussions between interventions.
A
时间窗: Ongoing
To contrast the efficacy of an evidence-based streamlined consent model (based upon the integration of an expert opinion model and laypersons responses using a mental- models approach) to a standard NIH consent in consenting adult and parent participants to undergo WES/WGS within NIH Intramural studies.
C
时间窗: Ongoing
To describe satisfaction,decisional conflict and residual questions and concerns following use of each consent intervention.
次要结局
未报告次要终点