title: The challenge of informed consent and return of results in translational genomics: empirical analysis and recommendations.
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.
authors.affiliation: Professor and the Chair of Social Medicine in the School of Medicine and an Adjunct Professor of Sociology at the University of North Carolina at Chapel Hill.
authors.forename: Gail E
authors.initials: GE
authors.lastname: Henderson
authors.forename: Susan M
authors.initials: SM
authors.lastname: Wolf
authors.forename: Kristine J
authors.initials: KJ
authors.lastname: Kuczynski
authors.forename: Steven
authors.initials: S
authors.lastname: Joffe
authors.forename: Richard R
authors.initials: RR
authors.lastname: Sharp
authors.forename: D Williams
authors.initials: DW
authors.lastname: Parsons
authors.forename: Bartha M
authors.initials: BM
authors.lastname: Knoppers
authors.forename: Joon-Ho
authors.initials: JH
authors.lastname: Yu
authors.forename: Paul S
authors.initials: PS
authors.lastname: Appelbaum
mesh_terms: D030661:Genetic Privacy; D036281:Genetic Research / Q000941:ethics*; D023281:Genomics; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent / Q000941:ethics*; D057240:Patient Preference; D017422:Sequence Analysis, DNA / Q000941:ethics*; D057170:Translational Research, Biomedical