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Completed

NCT Number: NCT01927770

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

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.

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Key information

Conditions

Whole Genome Sequencing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

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

models. A descriptive analysis of the audiotaped consent process will also be conducted to

assess differences in the content or extent of the process, and related outcomes of satisfaction and decisional conflict will also be assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

Eligible adults (greater than or equal to 18 years of age) consenting to enroll in an NIH study that includes WES/WGS. Parents of eligible children (<18 years of age) consenting to enroll their child(ren) in an NIH study that includes WES/WGS. Participants must be cognitively able to consent and fluent in written and spoken English.

Exclusion criteria

Children (<18 years of age). Non-English speaking participants (until the study has evolved to be able to use translations of the interventions into Spanish).

Treatment and study plan

Primary outcomes

  1. A

    Time frame: 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.

  2. B

    Time frame: Ongoing

    To quantitatively assess changes in understanding, perceptions of uncertainty and informed choice between the two consent interventions, assuming equivalency.

  3. C

    Time frame: Ongoing

    To describe satisfaction,decisional conflict and residual questions and concerns following use of each consent intervention.

  4. D

    Time frame: Ongoing

    To compare the content, dialogue and time spent in the consent discussions between interventions.

Sponsors and collaborators

Lead sponsor

National Human Genome Research Institute (NHGRI)

Nih

Registry information

Official study title

Randomized Trial of Consent Interventions for NIH Whole Exome and Whole Genome Sequencing Studies

Important dates

Study start
2013
Primary completion
2016
Study completion
2021
First posted
Aug 23, 2013
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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