An observational study in Whole Genome Sequencing, sponsored by National Human Genome Research Institute (NHGRI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-10.
Sponsored by National Human Genome Research Institute (NHGRI) · Observational
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:
Eligibility:
Design:
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.
National Human Genome Research Institute (NHGRI) is the lead sponsor of 199 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Parents and eligible children.
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).
Eligible adults (or parents of eligible children) consenting to enroll in an NIH study thatincludes WES/WGS.
A
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.
Time frame: Ongoing
B
To quantitatively assess changes in understanding, perceptions of uncertainty and informed choice between the two consent interventions, assuming equivalency.
Time frame: Ongoing
C
To describe satisfaction,decisional conflict and residual questions and concerns following use of each consent intervention.
Time frame: Ongoing
D
To compare the content, dialogue and time spent in the consent discussions between interventions.
Time frame: Ongoing
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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National Human Genome Research Institute (NHGRI)