Blog
About

20
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Discussion

          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.

          Summary

          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.

          Related collections

          Most cited references 27

          • Record: found
          • Abstract: not found
          • Article: not found

          An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.

            Bookmark
            • Record: found
            • Abstract: found
            • Article: found
            Is Open Access

            Written informed consent and selection bias in observational studies using medical records: systematic review

            Objectives To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies. Design Systematic review. Data sources Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations. Study selection Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements. Data extraction Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias. Results Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161?604 eligible patients, 66.9% consented to use of data from their medical records. Conclusions Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              Assessment of generalisability in trials of health interventions: suggested framework and systematic review.

                Bookmark

                Author and article information

                Contributors
                Kevin_fiscella@urmc.rochester.edu
                jntobin@CDNetwork.org
                Jennifer.2.carroll@ucdenver.edu
                Hua_he@urmc.rochester.edu
                Olugbenga.Ogedegbe@nyumc.org
                Journal
                BMC Med Ethics
                BMC Med Ethics
                BMC Medical Ethics
                BioMed Central (London )
                1472-6939
                17 September 2015
                17 September 2015
                2015
                : 16
                Affiliations
                [ ]Department of Family Medicine, University of Rochester Medical Center, Rochester, USA
                [ ]Clinical Directors Network (CDN), New York, NY USA
                [ ]Albert Einstein College of Medicine of Yeshiva University, Bronx, NY USA
                [ ]The Rockefeller University Center for Clinical and Translational Science, New York, NY USA
                [ ]Department of Family Medicine, University of Colorado, Denver, USA
                [ ]Department of Biostatistics, University of Rochester Medical Center, Rochester, NY USA
                [ ]Department of Population Health, Center for Healthful Behavior Change, New York University Langone Medical Center, New York, NY USA
                [ ]Family Medicine Research, 1381 South Ave, Rochester, NY 14620 USA
                Article
                56
                10.1186/s12910-015-0056-2
                4574354
                © Fiscella et al. 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Debate
                Custom metadata
                © The Author(s) 2015

                Comments

                Comment on this article