The challenge of informed consent and return of results in translational genomics: empirical analysis and recommendations

J Law Med Ethics. 2014 Fall;42(3):344-55. doi: 10.1111/jlme.12151.

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Genetic Privacy
  • Genetic Research / ethics*
  • Genomics*
  • Humans
  • Information Dissemination
  • Informed Consent / ethics*
  • Patient Preference
  • Sequence Analysis, DNA / ethics*
  • Translational Research, Biomedical