title: Ethical and practical challenges to studying patients who opt out of large-scale biorepository research.
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.
authors.affiliation: Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
authors.forename: S Trent
authors.initials: ST
authors.lastname: Rosenbloom
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Madison
authors.forename: Kyle B
authors.initials: KB
authors.lastname: Brothers
authors.forename: Erica A
authors.initials: EA
authors.lastname: Bowton
authors.forename: Ellen Wright
authors.initials: EW
authors.lastname: Clayton
authors.forename: Bradley A
authors.initials: BA
authors.lastname: Malin
authors.forename: Dan M
authors.initials: DM
authors.lastname: Roden
authors.forename: Jill
authors.initials: J
authors.lastname: Pulley
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics* / Q000379:methods; D057286:Electronic Health Records / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D010342:Patient Acceptance of Health Care
keywords: Biomedical Ethics; Biorepositories; Informed Consent; Medical Informatics Computing; Medical Records Systems, Computerized; Support, U.S. Gov’t, P.H.S.