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A Study of Consent Forms for Whole Exome and Whole Genome Sequencing

NCT01927770 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 212

Last updated 2021-11-10

No results posted yet for this study

Summary

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.

Conditions

  • Whole Genome Sequencing

Sponsors & Collaborators

  • National Human Genome Research Institute (NHGRI)

    lead NIH

Principal Investigators

  • Julie Sapp · National Human Genome Research Institute (NHGRI)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-16
Primary Completion
2016-03-07
Completion
2021-11-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01927770 on ClinicalTrials.gov