title: Informed consent for return of incidental findings in genomic research.
abstract: OBJECTIVE
  Researchers face the dilemma of how to obtain consent for return of incidental findings from genomic research. We surveyed and interviewed investigators and study participants, with the goal of providing suggestions for how to shape the consent process.
  
  
  METHODS
  We performed an online survey of 254 US genetic researchers identified through the NIH RePORTER database, abstracts from the 2011 American Society of Human Genetics meeting, and qualitative semi-structured interviews with 28 genomic researchers and 20 research participants.
  
  
  RESULTS
  Most researchers and participants endorsed disclosure of a wide range of information about return of incidental findings, including risks, benefits, impact on family members, data security, and procedures, for return of results in the event of death or incapacity and for recontact. However, most researchers were willing to devote 30 min or less to this process and expressed concerns that disclosed information would overwhelm participants, a concern shared by many participants themselves.
  
  
  CONCLUSIONS
  There is a disjunction between the views of investigators and participants about the amount of information that should be disclosed and the practical realities of the research setting, including the time available for consent discussions. This strongly suggests the need for innovative approaches to the informed consent process.
authors.affiliation: Department of Psychiatry, Columbia University Medical Center and NY State Psychiatric Institute, New York, New York, USA.
authors.forename: Paul S
authors.initials: PS
authors.lastname: Appelbaum
authors.affiliation: The Hastings Center, Garrison, New York, USA.
authors.forename: Cameron R
authors.initials: CR
authors.lastname: Waldman
authors.affiliation: Department of Psychiatry, Columbia University Medical Center and NY State Psychiatric Institute, New York, New York, USA.
authors.forename: Abby
authors.initials: A
authors.lastname: Fyer
authors.affiliation: Department of Psychiatry, Columbia University Medical Center and NY State Psychiatric Institute, New York, New York, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Klitzman
authors.affiliation: The Hastings Center, Garrison, New York, USA.
authors.forename: Erik
authors.initials: E
authors.lastname: Parens
authors.affiliation: Department of Pediatrics, Columbia University Medical Center, New York, New York, USA.
authors.forename: Josue
authors.initials: J
authors.lastname: Martinez
authors.affiliation: Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, Massachusetts, USA.
authors.forename: W Nicholson
authors.initials: WN
authors.lastname: Price
authors.affiliation: 1] Department of Pediatrics, Columbia University Medical Center, New York, New York, USA [2] Department of Medicine, Columbia University Medical Center, New York, New York, USA.
authors.forename: Wendy K
authors.initials: WK
authors.lastname: Chung
mesh_terms: D022126:Access to Information; D000328:Adult; D001483:Base Sequence; D003625:Data Collection; D030881:Disclosure; D005260:Female; D036281:Genetic Research; D016678:Genome / Q000235:genetics*; D023281:Genomics; D006801:Humans; D033162:Incidental Findings; D007258:Informed Consent; D008297:Male; D017422:Sequence Analysis, DNA