Preferences for opt-in and opt-out enrollment and consent models in biobank research: a national survey of Veterans Administration patients

Genet Med. 2012 Sep;14(9):787-94. doi: 10.1038/gim.2012.45. Epub 2012 Apr 26.

Abstract

Purpose: 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.

Conclusion: 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.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Biological Specimen Banks / ethics*
  • Biological Specimen Banks / organization & administration
  • Biomedical Research / organization & administration*
  • Cohort Studies
  • Continental Population Groups
  • Data Collection / statistics & numerical data
  • Decision Support Techniques
  • Ethics, Research*
  • Female
  • Genomics / ethics*
  • Genomics / organization & administration
  • Humans
  • Informed Consent / psychology*
  • Male
  • Middle Aged
  • United States
  • United States Department of Veterans Affairs
  • Veterans / psychology*