Open AccessThe Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations
Author(s) -
Henderson Gail E.,
Wolf Susan M.,
Kuczynski Kristine J.,
Joffe Steven,
Sharp Richard R.,
Parsons D. Williams,
Knoppers Bartha M.,
Yu JoonHo,
Appelbaum Paul S.
Publication year - 2014
Publication title -
the journal of law, medicine & ethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.515
H-Index - 57
eISSN - 1748-720X
pISSN - 1073-1105
DOI - 10.1111/jlme.12151
Subject(s) - informed consent , exome , exome sequencing , genomics , data sharing , medline , medicine , genome , alternative medicine , biology , genetics , pathology , gene , mutation , biochemistry
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.