An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics
Abstract
Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion .
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Some believe that patients have an obligation to contribute to improving the quality of the health care system.
“Regarding the sharing of health care data, some believe that patients have an obligation to contribute to improving the quality of the health care system [90].”
From Ethics and governance of trustworthy medical artificial intelligence (2023) · cites this paper as [90]
Cites
Institute of Medicine (2000) · National Academies Press eBooks · doi:10.17226/9728 · Cited by 14,174 · see citing works
To Err is Human: Building a Safer Health System
Hendee, W. R. (2001) · Journal of Vascular and Interventional Radiology · doi:10.1016/s1051-0443(01)70072-3 · Cited by 10,122 · see citing works
A Theory of Justice: Original Edition
Rawls, J. (1971) · doi:10.4159/9780674042605 · Cited by 9,496 · see citing works
The quality of health care delivered to adults in the United States
McGlynn, E. A., Asch, S. M., Adams, J., Keesey, J., Hicks, J., DeCristofaro, A., & Kerr, E. A. (2003) · New England Journal of Medicine · doi:10.1056/nejmsa022615 · Cited by 5,079 · see citing works
An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU
Pronovost, P., Needham, D., Berenholtz, S., Sinopoli, D., Chu, H., Cosgrove, S., Sexton, B., Hyzy, R., Welsh, R., Roth, G., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa061115 · Cited by 4,387 · see citing works
Self-citationEckstein, S. (2003) · Cambridge University Press eBooks · doi:10.1017/cbo9780511550089.028 · Cited by 3,487 · see citing works
Stanford encyclopedia of philosophy
(1998) · Choice Reviews Online · doi:10.5860/choice.35-4860 · Cited by 3,438 · see citing works
Estimating Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002
Klevens, R. M., Edwards, J. R., Richards, C. L., Horan, T. C., Gaynes, R. P., Pollock, D. A., & Cardo, D. M. (2007) · Public Health Reports · doi:10.1177/003335490712200205 · Cited by 2,961 · see citing works
Essays, Moral, Political, and Literary
Hume, D. (2021) · Oxford University Press eBooks · doi:10.1093/oseo/instance.00280189 · Cited by 2,874 · see citing works
Sackett, D. L. (1997) · Seminars in Perinatology · doi:10.1016/s0146-0005(97)80013-4 · Cited by 1,063 · see citing works
Social Justice: The Moral Foundations of Public Health and Health Policy
Powers, M., & Faden, R. (2006) · Cited by 743 · see citing works
Self-citationRights, Justice, and the Bounds of Liberty
Feinberg, J. (1980) · Princeton University Press eBooks · doi:10.1515/9781400853977 · Cited by 726 · see citing works
Toward a Normative Definition of Medical Professionalism
Swick, H. M. (2000) · Academic Medicine · doi:10.1097/00001888-200006000-00010 · Cited by 660 · see citing works
The Learning Healthcare System: Workshop Summary
Olsen, L., Aisner, D. L., & McGinnis, J. M. (2013) · Cited by 588 · see citing works
Achieving a Nationwide Learning Health System
Friedman, C. P., Wong, A. K., & Blumenthal, D. (2010) · Science Translational Medicine · doi:10.1126/scitranslmed.3001456 · Cited by 539 · see citing works
Medical professionalism in the new millennium: a physicians' charter
(2002) · The Lancet · doi:10.1016/s0140-6736(02)07684-5 · Cited by 483 · see citing works
American College of Physicians Ethics Manual
Snyder, L. (2012) · Annals of Internal Medicine · doi:10.7326/0003-4819-156-1-201201031-00001 · Cited by 354 · see citing works
A Rapid-Learning Health System
Etheredge, L. M. (2007) · Health Affairs · doi:10.1377/hlthaff.26.2.w107 · Cited by 345 · see citing works
Scientific research is a moral duty
Harris, J. (2005) · Journal of Medical Ethics · doi:10.1136/jme.2005.011973 · Cited by 328 · see citing works
Diagnostic errors in the intensive care unit: a systematic review of autopsy studies
Winters, B. D., Custer, J. W., Galvagno, S. M., Colantuoni, E., Kapoor, S. G., Lee, H. W., Goode, V. H., Robinson, K. A., Nakhasi, A., Pronovost, P. J., et al. (2012) · BMJ Quality & Safety · doi:10.1136/bmjqs-2012-000803 · Cited by 286 · see citing works
Self-citationDetermining When Quality Improvement Initiatives Should Be Considered Research
Casarett, D., Karlawish, J. H., & Sugarman, J. (2000) · JAMA · doi:10.1001/jama.283.17.2275 · Cited by 233 · see citing works
The challenge of rising health care costs – a view from the Congressional Budget Office
Orszag, P. R., & Ellis, P. (2007) · New England Journal of Medicine · doi:10.1056/nejmp078190 · Cited by 224 · see citing works
The need for needs assessment in continuing medical education
Norman, G. R., Shannon, S., & Marrin, M. L. (2004) · BMJ · doi:10.1136/bmj.328.7446.999 · Cited by 198 · see citing works
Rhodes, R. (2005) · The American Journal of Bioethics · doi:10.1080/15265160590900678 · Cited by 196 · see citing works
The Ethics of Consent: Theory and Practice
Veatch, R. M. (2010) · JAMA · doi:10.1001/jama.2010.849 · Cited by 193 · see citing works
The second wave: Toward responsible inclusion of pregnant women in research.
Lyerly, A. D., Little, M. O., & Faden, R. (2008) · PubMed · doi:10.1353/ijf.0.0047 · Cited by 193 · see citing works
Self-citationEducational Differences in U.S. Adult Mortality
Masters, R. K., Hummer, R. A., & Powers, D. A. (2012) · American Sociological Review · doi:10.1177/0003122412451019 · Cited by 187 · see citing works
Special Report: The Ethics of Using QI Methods to Improve Health Care Quality and Safety
Baily, M. A., Bottrell, M. M., Lynn, J., & Jennings, B. (2006) · The Hastings Center Report · doi:10.1353/hcr.2006.0054 · Cited by 185 · see citing works
The Obligation to Participate in Biomedical Research
Schaefer, G. O. (2009) · JAMA · doi:10.1001/jama.2009.931 · Cited by 171 · see citing works
Percival, T. (2014) · Cambridge University Press eBooks · doi:10.1017/cbo9781107360518 · Cited by 170 · see citing works
Wolf, S. (2005) · Cambridge University Press eBooks · doi:10.1017/cbo9780511614194 · Cited by 166 · see citing works
Defining medical professionalism: a qualitative study
Wagner, P. J., Je, H., MOSELEY, G. C., & Hudson, V. L. (2007) · Medical Education · doi:10.1111/j.1365-2929.2006.02695.x · Cited by 164 · see citing works
Autonomy: A Moral Good, Not a Moral Obsession
Callahan, D. (1984) · The Hastings Center Report · doi:10.2307/3561098 · Cited by 158 · see citing works
The second wave: Toward responsible inclusion of pregnant women in research
Lyerly, A. D., Little, M. O., & Faden, R. (2008) · International Journal of Feminist Approaches to Bioethics · doi:10.3138/ijfab.1.2.5 · Cited by 155 · see citing works
Self-citationThe Learning Healthcare System
Institute of Medicine (2007) · National Academies Press eBooks · doi:10.17226/11903 · Cited by 138 · see citing works
What Does ‘Respect’ Mean? Exploring the Moral Obligation of Health Professionals to Respect Patients
Beach, M. C., Duggan, P. S., Cassel, C. K., & Geller, G. (2007) · Journal of General Internal Medicine · doi:10.1007/s11606-006-0054-7 · Cited by 115 · see citing works
Can Research and Care Be Ethically Integrated?
Largent, E. A., Joffe, S., & Miller, F. G. (2011) · The Hastings Center Report · doi:10.1002/j.1552-146x.2011.tb00123.x · Cited by 109 · see citing works
Addressing Rising Health Care Costs — A View from the Congressional Budget Office
Orszag, P. R., & Ellis, P. A. (2007) · New England Journal of Medicine · doi:10.1056/nejmp078191 · Cited by 105 · see citing works
Physician Autonomy and Health Care Reform
Emanuel, E. J., & Pearson, S. D. (2012) · JAMA · doi:10.1001/jama.2012.19 · Cited by 96 · see citing works
Haywood, C., Lanzkron, S., Hughes, M. T., Brown, R., Massa, M., Ratanawongsa, N., & Beach, M. C. (2010) · Journal of General Internal Medicine · doi:10.1007/s11606-010-1605-5 · Cited by 92 · see citing works
Medical ethics: Code of Medical Ethics: Current Opinions With Annotations
Caplan, A. L. (1995) · JAMA · doi:10.1001/jama.273.15.1232 · Cited by 90 · see citing works
The battering of informed consent
Kottow, M. (2004) · Journal of Medical Ethics · doi:10.1136/jme.2003.002949 · Cited by 83 · see citing works
Medical professionalism project
Woollard, K. V. (2003) · The Medical Journal of Australia · doi:10.5694/j.1326-5377.2003.tb05080.x · Cited by 70 · see citing works
Baily, M. A. (2008) · New England Journal of Medicine · doi:10.1056/nejmp0800372 · Cited by 68 · see citing works
The historical foundations of the research-practice distinction in bioethics
Beauchamp, T. L., & Saghai, Y. (2012) · Metamedicine · doi:10.1007/s11017-011-9207-8 · Cited by 60 · see citing works
Self-citationFREE RIDERS AND PIOUS SONS – WHY SCIENCE RESEARCH REMAINS OBLIGATORY
Chan, S., & Harris, J. (2008) · Bioethics · doi:10.1111/j.1467-8519.2008.00648.x · Cited by 53 · see citing works
14 Consent to Medical Care: The Importance of Fiduciary Context
Joffe, S., & Truog, R. D. (2009) · doi:10.1093/acprof:oso/9780195335149.003.0014 · Cited by 44 · see citing works
Is There a Duty to Serve as a Subject in Biomedical Research?
Caplan, A. L. (1984) · IRB Ethics and Human Research · doi:10.2307/3563928 · Cited by 43 · see citing works
Orentlicher, D. (2005) · The Hastings Center Report · doi:10.1353/hcr.2005.0083 · Cited by 35 · see citing works
DEFENDING THE DUTY TO RESEARCH?
Brassington, I. (2009) · Bioethics · doi:10.1111/j.1467-8519.2009.01745.x · Cited by 30 · see citing works
Blando, P. (1998) · PubMed · Cited by 28 · see citing works
Evaluation of a Train-the-Trainer Workshop on Sickle Cell Disease for ED Providers
Tanabe, P. J., Stevenson, A., DeCastro, L. M., et al. (2011) · Journal of Emergency Nursing · doi:10.1016/j.jen.2011.05.010 · Cited by 19 · see citing works
British Medical Journal Publishing Group (1849) · BMJ · doi:10.1136/bmj.s1-13.26.711 · Cited by 18 · see citing works
Meakins, J. L. (2003) · Journal of the American College of Surgeons · doi:10.1016/s1072-7515(02)01669-1 · Cited by 12 · see citing works
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- Authors
- Faden, R. R., Kass, N. E., Goodman, S. N., Pronovost, P., Tunis, S., & Beauchamp, T. L.
- Venue
- Hastings Center Report
- Publisher
- Wiley
- Published
- 2013-01
- Volume
- 43
- Issue
- s1
- Pages
- S16-27
- ISSN
- 0093-0334 (ISSN-L)
- 1552-146X
- OpenAlex
- W1984044747
- Cited by
- 498
- References
- 55
- Citations by year
- 2026: 19 · 2025: 23 · 2024: 25 · 2023: 30 · 2022: 39 · 2021: 52 · 2020: 55 · 2019: 47 · 2018: 50 · 2017: 32 · 2016: 36 · 2015: 40 · 2014: 27 · 2013: 22
- FWCI
- 42.61
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Hastings Center Report (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health, National Center for Research Resources (RC1RR028876)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Health Professions › General Health Professions › Ethics in medical practice
- Keywords
- learning healthcare systems, research ethics, clinical ethics, ethics framework, embedded research
- MeSH terms
- Clinical Competence, Delivery of Health Care, Education, Professional, Patient Care, Health Personnel, Humans, Judgment, Patients, Physicians, Quality of Health Care, Social Justice, United States, Personal Autonomy, Ethics, Clinical, Moral Obligations, Ethics, Research
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