title: Preferences for opt-in and opt-out enrollment and consent models in biobank research: a national survey of Veterans Administration patients.
abstract: OBJECTIVE
  In 2006, the Department of Veterans Affairs launched the Genomic Medicine Program with the goal of using genomic information to personalize and improve health care for veterans. A step toward this goal is the Million Veteran Program, which aims to enroll a million veterans in a longitudinal cohort study and establish a database with genomic, lifestyle, military-exposure, and health information. Before the launch of the Million Veteran Program, a survey of Department of Veterans Affairs patients was conducted to measure preferences for opt-in and opt-out models of enrollment and consent.
  
  
  METHODS
  An online survey was conducted with a random sample of 451 veterans. The survey described the proposed Million Veteran Program database and asked respondents about the acceptability of opt-in and opt-out models of enrollment. The study examined differences in responses among demographic groups and relationships between beliefs about each model and willingness to participate.
  
  
  RESULTS
  Most respondents were willing to participate under both opt-in (80%) and opt-out (69%) models. Nearly 80% said they would be comfortable providing access to residual clinical samples for research. At least half of respondents did not strongly favor one model over the other; of those who expressed a preference, significantly more people said they would participate in a study using opt-in methods. Stronger preferences for the opt-in approach were expressed among younger patients and Hispanic patients.
  
  
  CONCLUSIONS
  Support for the study and willingness to participate were high for both enrollment models. The use of an opt-out model could impede recruitment of certain demographic groups, including Hispanic patients and patients under the age of 55 years.
authors.affiliation: Genetics and Public Policy Center, Berman Institute of Bioethics, Johns Hopkins University, Washington, DC, USA. dkaufma2@jhu.edu
authors.forename: David
authors.initials: D
authors.lastname: Kaufman
authors.forename: Juli
authors.initials: J
authors.lastname: Bollinger
authors.forename: Rachel
authors.initials: R
authors.lastname: Dvoskin
authors.forename: Joan
authors.initials: J
authors.lastname: Scott
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018070:Biological Specimen Banks / Q000941:ethics* / Q000458:organization & administration; D035843:Biomedical Research / Q000458:organization & administration*; D015331:Cohort Studies; D003625:Data Collection / Q000706:statistics & numerical data; D003661:Decision Support Techniques; D032984:Ethics, Research; D005260:Female; D023281:Genomics / Q000941:ethics* / Q000458:organization & administration; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D044469:Racial Groups; D014481:United States; D014493:United States Department of Veterans Affairs; D014728:Veterans / Q000523:psychology*