title: Ethics Issues Arising in the Transition to Learning Health Care Systems: Results from Interviews with Leaders from 25 Health Systems.
abstract: BACKGROUND
  There is increased interest in transitioning to a "learning health care system" (LHCS). While this transition brings the potential for significant benefits, it also presents several ethical considerations. Identifying the ethical issues faced by institutions in this transition is critical for realizing the goals of learning health care so that these issues can be anticipated and, where possible, resolved.
  
  
  METHODS
  29 semi-structured telephone interviews were conducted with leaders within 25 health care institutions. Respondents were recruiting using purposive sampling, targeting institutions considered as LHCS leaders. All interviews were audiorecorded and transcribed. NVIVO10 software was used to support qualitative analysis.
  
  
  RESULTS
  Respondents described seven ethical challenges: (1) ethical oversight of learning activities; (2) transparency of learning activities to patients; (3) potential tensions between improving quality and reducing costs; (4) data sharing and data management; (5) lag time between discovery and implementation; (6) transparency to patients about quality; and (7) randomization for quality improvement initiatives.
  
  
  CONCLUSIONS
  To move towards LHCS, several ethical considerations require further attention, including: the continued appropriateness of the research-treatment distinction; policy frameworks for privacy and data sharing; informing patients about learning activities; obligations to share data on quality; and the potential for trade-offs between quality improvement and cost control.
  
  
  CONCLUSIONS
  To our knowledge, this is the first project to ask leaders from health care systems committed to ongoing learning about the ethical issues they have faced in this effort. Their experiences can provide guidance on relevant ethical issues, and what might be done to resolve them.
authors.affiliation: Center for Medical Ethics & Health Policy, Baylor College of Medicine.
authors.forename: Stephanie R
authors.initials: SR
authors.lastname: Morain
authors.affiliation: Berman Institute of Bioethics, Johns Hopkins University.
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Kass
keywords: Comparative Effectiveness Research; Ethics; Learning Health Care; Organizational Innovation