Variation among Consent Forms for Clinical Whole Exome Sequencing.

Document Type

Article

Publication Date

2-2018

Identifier

PMID:28689263; DOI: 10.1007/s10897-017-0127-2; PMCID: PMC5794809

Abstract

The goal of this study was to explore variation among informed consent documents for clinical whole exome sequencing (WES) in order to identify the level of consistency with the recommendations from the American College of Medical Genetics and Genomics (ACMG) and the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) regarding informed consent for clinical WES. Recommendations were organized into a framework of key points for analysis. Content analysis was conducted on a sample of informed consent documents for clinical WES downloaded from 18 laboratory websites. We observed considerable variability in the content of informed consent documents among the sample of 18 laboratories. The mean Flesch-Kincaid Grade Level, a measure of readability, of the consent forms was 10.8, above the recommended 8th grade level. For each of the individual ACMG and Bioethics Commission recommendations, the frequency of inclusion ranged from 11% to 100%. For the overall list of 18 consent items, inclusion ranged from 11 to 17 items (Mean = 13.44, Mode = 14). This analysis will be useful to laboratories that wish to create informed consent documents that comply with these recommendations. The consistent use of standardized informed consent process could improve communication between clinicians and patients and increase understanding of genetic testing.

Journal Title

Journal of genetic counseling

Volume

27

Issue

1

First Page

104

Last Page

114

MeSH Keywords

Whole Exome Sequencing; Informed Consent; Consent Forms/standards

Keywords

whole exome sequence; informed consent

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