The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations. Issue 3 (September 2014)

• Record Type: Journal Article
• Authors: Henderson, Gail E.; Wolf, Susan M.; Kuczynski, Kristine J.; Joffe, Steven; Sharp, Richard R.; Parsons, D. Williams; Knoppers, Bartha M.; Yu, Joon‐Ho; Appelbaum, Paul S.
• Is Part Of: Journal of law, medicine & ethics. Volume 42:Issue 3(2014)
• Page Start: 344
• Page End: 355
• Publication Date: 2014-09
• Subjects: Medical laws and legislation -- United States -- Periodicals; Medical care -- Law and legislation -- United States -- Periodicals; Medical ethics -- Periodicals; Jurisprudence -- Periodicals; Legislation, Medical -- Periodicals; Legislation, Nursing -- Periodicals; Ethics -- Periodicals; Forensic Medicine -- Periodicals; Nursing -- Periodicals; Medicine -- Periodicals; Societies -- Periodicals; Medical care -- Law and legislation; Medical ethics; Medical laws and legislation; United States; Periodicals; 344.73041
• DOI: 10.1111/jlme.12151
• Languages: English
• ISSNs: 1073-1105

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <p>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.</p> </abstract>