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J Am Med Inform Assoc 20:e221-e225 doi:10.1136/amiajnl-2013-001937
  • Perspective

Ethical and practical challenges to studying patients who opt out of large-scale biorepository research

  1. Jill Pulley4,8
  1. 1Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  2. 2Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  3. 3Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  4. 4Office of Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  5. 5Kosair Charities Pediatric Research Unit, Department of Pediatrics, University of Louisville School of Medicine, Louisville, Kentucky, USA
  6. 6Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  7. 7Department of Electrical Engineering and Computer Science, Vanderbilt University, Nashville, Tennessee, USA
  8. 8Office of Personalized Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  1. Correspondence to Dr S Trent Rosenbloom, Eskind Biomedical Library, 2209 Garland Avenue, Nashville, TN 37232-8340, USA; trent.rosenbloom{at}vanderbilt.edu
  • Received 15 April 2013
  • Revised 19 June 2013
  • Accepted 5 July 2013
  • Published Online First 25 July 2013

Abstract

Large-scale biorepositories that couple biologic specimens with electronic health records containing documentation of phenotypic expression can accelerate scientific research and discovery. However, differences between those subjects who participate in biorepository-based research and the population from which they are drawn may influence research validity. While an opt-out approach to biorepository-based research enhances inclusiveness, empirical research evaluating voluntariness, risk, and the feasibility of an opt-out approach is sparse, and factors influencing patients’ decisions to opt out are understudied. Determining why patients choose to opt out may help to improve voluntariness, however there may be ethical and logistical challenges to studying those who opt out. In this perspective paper, the authors explore what is known about research based on the opt-out model, describe a large-scale biorepository that leverages the opt-out model, and review specific ethical and logistical challenges to bridging the research gaps that remain.

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