title: iCONCUR: informed consent for clinical data and bio-sample use for research.
abstract: Implementation of patient preferences for use of electronic health records for research has been traditionally limited to identifiable data. Tiered e-consent for use of de-identified data has traditionally been deemed unnecessary or impractical for implementation in clinical settings.
  
  
  
  We developed a web-based tiered informed consent tool called informed consent for clinical data and bio-sample use for research (iCONCUR) that honors granular patient preferences for use of electronic health record data in research. We piloted this tool in 4 outpatient clinics of an academic medical center.
  
  
  
  Of patients offered access to iCONCUR, 394 agreed to participate in this study, among whom 126 patients accessed the website to modify their records according to data category and data recipient. The majority consented to share most of their data and specimens with researchers. Willingness to share was greater among participants from an Human Immunodeficiency Virus (HIV) clinic than those from internal medicine clinics. The number of items declined was higher for for-profit institution recipients. Overall, participants were most willing to share demographics and body measurements and least willing to share family history and financial data. Participants indicated that having granular choices for data sharing was appropriate, and that they liked being informed about who was using their data for what purposes, as well as about outcomes of the research.
  
  
  
  This study suggests that a tiered electronic informed consent system is a workable solution that respects patient preferences, increases satisfaction, and does not significantly affect participation in research.
authors: Department of Biomedical Informatics, University of California, San Diego, USA.
authors: Hyeoneui
authors: H
authors: Kim
authors: Department of Biomedical Informatics, University of California, San Diego, USA.
authors: Elizabeth
authors: E
authors: Bell
authors: Department of Biomedical Informatics, University of California, San Diego, USA.
authors: Jihoon
authors: J
authors: Kim
authors: Department of Biomedical Informatics, University of California, San Diego, USA.|Department of Medicine, University of California, San Diego, USA.
authors: Amy
authors: A
authors: Sitapati
authors: Department of Medicine, University of California, San Diego, USA.
authors: Joe
authors: J
authors: Ramsdell
authors: Department of Biomedical Informatics, University of California, San Diego, USA.
authors: Claudiu
authors: C
authors: Farcas
authors: Department of Computer Science and Engineering, University of California San Diego, San Diego, USA.
authors: Dexter
authors: D
authors: Friedman
authors: Department of Biomedical Informatics, University of California, San Diego, USA.
authors: Stephanie Feudjio
authors: SF
authors: Feupe
authors: Department of Biomedical Informatics, University of California, San Diego, USA.|Clinical and Translational Research Institute, University of California, San Diego, USA.
authors: Lucila
authors: L
authors: Ohno-Machado
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D057286:Electronic Health Records; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D033181:Information Dissemination / Q000941:ethics; D007258:Informed Consent; D008297:Male; D057240:Patient Preference; D012959:Socioeconomic Factors
keywords: EHR data use for research; informed consent; tiered informed consent