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

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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.

Original languageEnglish (US)
Pages (from-to)344-355
Number of pages12
JournalJournal of Law, Medicine and Ethics
Volume42
Issue number3
DOIs
StatePublished - Sep 1 2014

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ASJC Scopus subject areas

  • Health Policy
  • Issues, ethics and legal aspects

Cite this

Henderson, G. E., Wolf, S. M., Kuczynski, K. J., Joffe, S., Sharp, R. R., Parsons, D. W., Knoppers, B. M., Yu, J. H., & Appelbaum, P. S. (2014). The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations. Journal of Law, Medicine and Ethics, 42(3), 344-355. https://doi.org/10.1111/jlme.12151