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Open Access 01-02-2018 | Original Research

Variation among Consent Forms for Clinical Whole Exome Sequencing

Authors: Sara A. Fowler, Carol J. Saunders, Mark A. Hoffman

Published in: Journal of Genetic Counseling | Issue 1/2018

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.

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Title: Variation among Consent Forms for Clinical Whole Exome Sequencing
Authors: Sara A. Fowler
Carol J. Saunders
Mark A. Hoffman
Publication date: 01-02-2018
Publisher: Springer US
Published in: Journal of Genetic Counseling / Issue 1/2018
Print ISSN: 1059-7700
Electronic ISSN: 1573-3599
DOI: https://doi.org/10.1007/s10897-017-0127-2

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