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

Research output: Contribution to journalArticle

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

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy

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    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