title: Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system.
abstract: BACKGROUND
  Institutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.
  
  
  CONCLUSIONS
  Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. Potentially, such ethical oversight could be provided by the integration of Institutional Review Boards and Clinical Ethical Committees, using a more integrated and streamlined approach such as a two-step process involving a screening review, followed by a review by committee trained in QIR. Standards for such ethical review and training in these standards, coupled with rapid review cycles, could facilitate an appropriate level of oversight within the context of creating and sustaining learning health care systems. We argue that QI and QIR are not reliably distinguishable. We advocate for approaches that improve protections for QI participants while minimizing over-protection for participants in QIR through reasonable ethical oversight that aligns risk to participants in both QI and QIR with the needs of a learning health care system.
authors.affiliation: Department of Family Medicine, University of Rochester Medical Center, Rochester, USA. Kevin_fiscella@urmc.rochester.edu.|Family Medicine Research, 1381 South Ave, Rochester, NY, 14620, USA. Kevin_fiscella@urmc.rochester.edu.
authors.forename: Kevin
authors.initials: K
authors.lastname: Fiscella
authors.affiliation: Clinical Directors Network (CDN), New York, NY, USA. jntobin@CDNetwork.org.|Albert Einstein College of Medicine of Yeshiva University, Bronx, NY, USA. jntobin@CDNetwork.org.|The Rockefeller University Center for Clinical and Translational Science, New York, NY, USA. jntobin@CDNetwork.org.
authors.forename: Jonathan N
authors.initials: JN
authors.lastname: Tobin
authors.affiliation: Department of Family Medicine, University of Colorado, Denver, USA. Jennifer.2.carroll@ucdenver.edu.
authors.forename: Jennifer K
authors.initials: JK
authors.lastname: Carroll
authors.affiliation: Department of Biostatistics, University of Rochester Medical Center, Rochester, NY, USA. Hua_he@urmc.rochester.edu.
authors.forename: Hua
authors.initials: H
authors.lastname: He
authors.affiliation: Department of Population Health, Center for Healthful Behavior Change, New York University Langone Medical Center, New York, NY, USA. Olugbenga.Ogedegbe@nyumc.org.
authors.forename: Gbenga
authors.initials: G
authors.lastname: Ogedegbe
mesh_terms: D001291:Attitude of Health Personnel; D035843:Biomedical Research / Q000941:ethics; D003219:Confidentiality / Q000941:ethics; D003695:Delivery of Health Care / Q000941:ethics / Q000592:standards; D028744:Ethics Committees, Research; D006302:Health Services Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D011785:Quality Assurance, Health Care / Q000941:ethics*; D058996:Quality Improvement / Q000941:ethics*