NCT01927770|Completed
A Study of Consent Forms for Whole Exome and Whole Genome Sequencing
Randomized Trial of Consent Interventions for NIH Whole Exome and Whole Genome Sequencing Studies
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Randomized Trial of Consent Interventions for NIH Whole Exome and Whole Genome Sequencing Studies
Sponsor study identifier
Secondary identifiers
observational
212
1 country
1
Study Start
December 16, 2013
Actual (reported)Primary Completion
March 7, 2016
Actual (reported)Study Completion
November 8, 2021
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 8, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 20, 2013
Actual (reported)August 23, 2013
Actual (reported)December 16, 2013
Actual (reported)March 7, 2016
Actual (reported)November 8, 2021
Actual (reported)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.
Ongoing
B
To quantitatively assess changes in understanding, perceptions of uncertainty and informed choice between the two consent interventions, assuming equivalency.
Ongoing
C
To describe satisfaction,decisional conflict and residual questions and concerns following use of each consent intervention.
Ongoing
D
To compare the content, dialogue and time spent in the consent discussions between interventions.
Ongoing
Eligible adults (or parents of eligible children) consenting to enroll in an NIH study thatincludes WES/WGS.
Parents and eligible children.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Ayuso C, Millan JM, Mancheno M, Dal-Re R. Informed consent for whole-genome sequencing studies in the clinical setting. Proposed recommendations on essential content and process. Eur J Hum Genet. 2013 Oct;21(10):1054-9. doi: 10.1038/ejhg.2012.297. Epub 2013 Jan 16.
Biesecker LG, Mullikin JC, Facio FM, Turner C, Cherukuri PF, Blakesley RW, Bouffard GG, Chines PS, Cruz P, Hansen NF, Teer JK, Maskeri B, Young AC; NISC Comparative Sequencing Program; Manolio TA, Wilson AF, Finkel T, Hwang P, Arai A, Remaley AT, Sachdev V, Shamburek R, Cannon RO, Green ED. The ClinSeq Project: piloting large-scale genome sequencing for research in genomic medicine. Genome Res. 2009 Sep;19(9):1665-74. doi: 10.1101/gr.092841.109. Epub 2009 Jul 14.
Julie Sapp
National Human Genome Research Institute (NHGRI)
212 participants (actual enrollment reported by the registry).
First Submitted
August 20, 2013
First Posted
August 23, 2013
Study Start
December 16, 2013
Actual (reported)Acquirement of Clinical and Genomic Data to Diagnose in Rare Inherited Cardiomyopathy
Contact the study team to confirm eligibility.
Dormandy E, Michie S, Hooper R, Marteau TM. Low uptake of prenatal screening for Down syndrome in minority ethnic groups and socially deprived groups: a reflection of women's attitudes or a failure to facilitate informed choices? Int J Epidemiol. 2005 Apr;34(2):346-52. doi: 10.1093/ije/dyi021. Epub 2005 Feb 28.
Turbitt E, Chrysostomou PP, Peay HL, Heidlebaugh AR, Nelson LM, Biesecker BB. A randomized controlled study of a consent intervention for participating in an NIH genome sequencing study. Eur J Hum Genet. 2018 May;26(5):622-630. doi: 10.1038/s41431-018-0105-7. Epub 2018 Feb 16.
Primary Completion
March 7, 2016
Actual (reported)Study Completion
November 8, 2021
Actual (reported)Last Updated
November 10, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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