Joanne Lynn, MD; Mary Ann Baily, PhD; Melissa Bottrell, PhD, MPH; Bruce Jennings, MA; Robert J. Levine, MD; Frank Davidoff, MD; David Casarett, MD; Janet Corrigan, PhD, MBA; Ellen Fox, MD; Matthew K. Wynia, MD, MPH; George J. Agich, PhD; Margaret O'Kane, MHA; Theodore Speroff, PhD; Paul Schyve, MD; Paul Batalden, MD; Sean Tunis, MD; Nancy Berlinger, PhD, MDiv; Linda Cronenwett, PhD, RN; J. Michael Fitzmaurice, PhD; Nancy Neveloff Dubler, LLB; Brent James, MD, MStat
Disclaimer: The study sponsors had no role in the work or in reviewing the final manuscripts. The authors are responsible for the content. Statements in this report should not be construed as an endorsement by the Agency for Healthcare Research and Quality or the employers of the authors, including federal agencies.
Acknowledgments: The authors thank the other members of the working group who did not join as authors: Michael Carome, MD (U.S. Department of Health and Human Services, Office for Human Research Protections); Stephen F. Jencks, MD, MPH, and Arnold Farley, PhD (Centers for Medicare & Medicaid Services); Karen Maschke, PhD (The Hastings Center); Ethel Mitty, EdD, RN (New York University College of Nursing); and Robyn Y. Nishimi, PhD (National Quality Forum).
Grant Support: By the Agency for Healthcare Research and Quality (grant 1R13HS13369) and unrestricted funds of The Hastings Center.
Potential Financial Conflicts of Interest: The authors share a broad dedication to improving health care delivery in the United States, and most have some of their income generated from these activities. Some are also engaged in research or in institutional review board or HIPAA privacy activities. However, none have any other direct conflicts of interest. The project did not require review as research involving human subjects.
Requests for Single Reprints: Mary Ann Baily, PhD, The Hastings Center, 21 Malcolm Gordon Road, Garrison, NY 10524; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Lynn: Office of Clinical Standards and Quality, The Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244.
Drs. Baily and Berlinger: The Hastings Center, 21 Malcolm Gordon Road, Garrison, NY 10524.
Dr. Bottrell: National Center for Ethics in Health Care, Veterans Health Administration, 814 Jones Street, Berkeley, CA 94710.
Mr. Jennings: Center for Humans and Nature, 109 West 77th Street, Suite 2, New York, NY 10024.
Dr. Levine: Institution for Social and Policy Studies, Interdisciplinary Center for Bioethics, PO Box 208209, New Haven, CT 06520-8209.
Dr. Davidoff: 143 Gordon Street, Wethersfield, CT 06109.
Dr. Casarett: Philadelphia Veterans Affairs Medical Center, 3615 Chestnut Street, Philadelphia, PA 19104.
Dr. Corrigan: National Quality Forum, 601 13th Street NW, Washington, DC 20005.
Dr. Fox: Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420.
Dr. Wynia: The Institute for Ethics at the American Medical Association, 515 North State Street, Chicago, IL 60610.
Dr. Agich: BGeXperience Program, 404A Moseley Hall, Bowling Green State University, Bowling Green, OH 43403.
Ms. O'Kane: National Committee for Quality Assurance, 2000 L Street NW, Suite 500, Washington, DC 20036.
Dr. Speroff: Vanderbilt University Medical Center, 1215 21st Avenue South, Nashville, TN 37232.
Dr. Schyve: Joint Commission on Accreditation of Healthcare Organizations, 1 Renaissance Boulevard, Oakbrook Terrace, IL 60181.
Dr. Batalden: Dartmouth Medical School, Strasenburgh Hall, Hanover, NH 03755.
Dr. Tunis: 4712 Keswick Road, Baltimore, MD 21210.
Dr. Cronenwett: University of North Carolina at Chapel Hill, Carrington Hall CB# 7460, Chapel Hill, NC 27599.
Dr. Fitzmaurice: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850.
Ms. Dubler: Division of Bioethics, Montefiore Medical Center, 111 East 210th Street, Bronx, NY 10467.
Dr. James: Intermountain Institute for Health Care Delivery Research, Intermountain Healthcare, 36 South State Street, 21st Floor, Salt Lake City, UT 84111.
Quality improvement (QI) activities can improve health care but must be conducted ethically. The Hastings Center convened leaders and scholars to address ethical requirements for QI and their relationship to regulations protecting human subjects of research. The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings and concluded that QI is an intrinsic part of normal health care operations. Both clinicians and patients have an ethical responsibility to participate in QI, provided that it complies with specified ethical requirements. Most QI activities are not human subjects research and should not undergo review by an institutional review board; rather, appropriately calibrated supervision of QI activities should be part of professional supervision of clinical practice. The group formulated a framework that would use key characteristics of a project and its context to categorize it as QI, human subjects research, or both, with the potential of a customized institutional review board process for the overlap category. The group recommended a period of innovation and evaluation to refine the framework for ethical conduct of QI and to integrate that framework into clinical practice.
Table 1. Ethical Requirements for the Protection of Human Participants in Quality Improvement Activities*
Table 2. Characteristics Helpful in Defining Activities as Both Quality Improvement and Human Subjects Research
Table 3. Recommendations for Implementing Accountability for the Ethical Conduct of Quality Improvement*
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Lynn J, Baily MA, Bottrell M, Jennings B, Levine RJ, Davidoff F, et al. The Ethics of Using Quality Improvement Methods in Health Care. Ann Intern Med. 2007;146:666–673. doi: 10.7326/0003-4819-146-9-200705010-00155
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Published: Ann Intern Med. 2007;146(9):666-673.
Ethics, Healthcare Delivery and Policy.
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