The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations

Gail E. Henderson; Susan M. Wolf; Kristine J. Kuczynski; Steven Joffe; Richard R. Sharp; D. Williams Parsons; Bartha M. Knoppers; Joon Ho Yu; Paul S. Appelbaum

doi:10.1111/jlme.12151

The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations

Gail E. Henderson, Susan M. Wolf, Kristine J. Kuczynski, Steven Joffe, Richard R. Sharp, D. Williams Parsons, Bartha M. Knoppers, Joon Ho Yu, Paul S. Appelbaum

Quantitative Health Sciences

Research output: Contribution to journal › Article › peer-review

49 Scopus citations

Abstract

As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations.

Original language	English (US)
Pages (from-to)	344-355
Number of pages	12
Journal	Journal of Law, Medicine and Ethics
Volume	42
Issue number	3
DOIs	https://doi.org/10.1111/jlme.12151
State	Published - Sep 1 2014

ASJC Scopus subject areas

General Medicine

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abstract = "As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations.",

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AU - Yu, Joon Ho

AU - Appelbaum, Paul S.

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The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations

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