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  1. Ethical Oversight in Quality Improvement and Quality Improvement Research: New Approaches to Promote a Learning Health Care System.Kevin Fiscella, Jonathan N. Tobin, Jennifer K. Carroll, Hua He & Gbenga Ogedegbe - 2015 - BMC Medical Ethics 16 (1):63.
    Institutional review boards distinguish health care quality improvement and health care quality improvement research 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.
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  • An Ethics Framework for a Learning Health Care System: A Departure From Traditional Research Ethics and Clinical Ethics.Ruth R. Faden, Nancy E. Kass, Steven N. Goodman, Peter Pronovost, Sean Tunis & Tom L. Beauchamp - 2013 - Hastings Center Report 43 (s1):16-27.
  • Learning Health Systems and the Revised Common Rule.Joshua A. Rolnick - 2019 - Journal of Law, Medicine and Ethics 47 (2):238-246.
    Quality improvement is an important function of learning health systems, and public policy should promote QI activities. Use of systematic methodologies in QI has prompted substantial confusion regarding when QI is human subjects research under the Common Rule, and this confusion persists with the revised Rule. Difficulty distinguishing research from QI imposes costs on the quality improvement process. I offer guidance to IRBs to mitigate these costs and suggest a new regulatory exclusion for minimal risk quality improvement activities.
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  • Data Citizenship and Informed Consent.Leslie P. Francis & John G. Francis - 2013 - American Journal of Bioethics 13 (4):38 - 39.
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  • Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB.David Perlman - 2012 - Journal of Law, Medicine and Ethics 40 (4):997-1007.
    A number of unique problems plague human research protection efforts at United States (U.S.) State and Territorial Departments of Health (DOHs) problems which might be ameliorated through a consolidated national or regional, independent, not-for-profit Institutional Review Board (IRB).
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  • Rethinking Local Institutional Review Board Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB.David Perlman - 2012 - Journal of Law, Medicine and Ethics 40 (4):997-1007.
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  • Ethical Oversight of Research on Patient Care.Mildred Z. Solomon & Ann C. Bonham - 2013 - Hastings Center Report 43 (s1):S2-S3.
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