TY - JOUR
T1 - The Challenge of Informed Consent and Return of Results in Translational Genomics
T2 - Empirical Analysis and Recommendations
AU - Henderson, Gail E.
AU - Wolf, Susan M.
AU - Kuczynski, Kristine J.
AU - Joffe, Steven
AU - Sharp, Richard R.
AU - Parsons, D. Williams
AU - Knoppers, Bartha M.
AU - Yu, Joon Ho
AU - Appelbaum, Paul S.
N1 - Publisher Copyright:
© 2014 American Society of Law, Medicine & Ethics, Inc.
PY - 2014/9/1
Y1 - 2014/9/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84910031008&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84910031008&partnerID=8YFLogxK
U2 - 10.1111/jlme.12151
DO - 10.1111/jlme.12151
M3 - Article
C2 - 25264092
AN - SCOPUS:84910031008
SN - 1073-1105
VL - 42
SP - 344
EP - 355
JO - Journal of Law, Medicine and Ethics
JF - Journal of Law, Medicine and Ethics
IS - 3
ER -