4.4 Article

Ethics and Informed Consent for Comparative Effectiveness Research With Prospective Electronic Clinical Data

期刊

MEDICAL CARE
卷 51, 期 8, 页码 S53-S57

出版社

LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/MLR.0b013e31829b1e4b

关键词

ethics; informed consent; comparative effectiveness research; electronic medical records

资金

  1. AcademyHealth
  2. NIH from the National Institutes of Health-National Center for Research Resources [RC1RR028876]

向作者/读者索取更多资源

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. Aims: 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. Results and 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.

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