title: Ethics and informed consent for comparative effectiveness research with prospective electronic clinical data.
abstract: BACKGROUND
  Electronic clinical data (ECD) will increasingly serve as an important source of information for comparative effectiveness research (CER). Although many retrospective studies have relied on ECD, new study designs propose using ECD for prospective CER. These designs have great potential but they also raise important ethics questions.
  
  
  OBJECTIVE
  Drawing on an ethics framework for learning health care systems, we identify morally relevant features of prospective CER-ECD studies by examining 1 case of an observational study and a second of a pragmatic, randomized trial. We focus only on questions of consent and assume research has been subject to appropriate ethics review and oversight.
  
  
  CONCLUSIONS
  We conclude that a CER-ECD observational study that imposes no or minimal additional risk to or burden on patients may proceed ethically without express informed consent from participants in settings where: (a) patients are regularly informed of the health care institution's commitment to learning through the integration of research and practice; and (b) there are appropriate protections for patients' rights and interests. In addition, where (a) and (b) apply, some pragmatic, randomized trials that similarly impose no or minimal additional risk to or burden on patients may also proceed ethically without express consent, when certain additional conditions are satisfied, including: (c) the trial does not negatively affect patients' prospects for good clinical outcomes; (d) physicians have the option of using an intervention other than the one assigned if they believe doing so is important for a particular patient; and (e) the trial does not engage preferences or values that are meaningful to patients.
authors.affiliation: Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA. rfaden@jhu.edu
authors.forename: Ruth
authors.initials: R
authors.lastname: Faden
authors.forename: Nancy
authors.initials: N
authors.lastname: Kass
authors.forename: Danielle
authors.initials: D
authors.lastname: Whicher
authors.forename: Walter
authors.initials: W
authors.lastname: Stewart
authors.forename: Sean
authors.initials: S
authors.lastname: Tunis
mesh_terms: D057186:Comparative Effectiveness Research / Q000941:ethics*; D057286:Electronic Health Records / Q000458:organization & administration*; D006302:Health Services Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D028701:Patient Rights; D011446:Prospective Studies; D012107:Research Design