An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics

Hastings Center Report

Volumn 43, Issue SUPPL. 1, 2013, Pages

  Faden, Ruth R ^a   Kass, Nancy E ^a   Goodman, Steven N ^a   Pronovost, Peter ^a   Tunis, Sean ^a   Beauchamp, Tom L ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL COMPETENCE; DECISION MAKING; EDUCATION; ETHICS; HEALTH CARE DELIVERY; HEALTH CARE PERSONNEL; HEALTH CARE QUALITY; HUMAN; MEDICAL ETHICS; METHODOLOGY; MORALITY; PATIENT; PATIENT CARE; PERSONAL AUTONOMY; PHYSICIAN; RESEARCH ETHICS; SOCIAL JUSTICE; STANDARD; UNITED STATES; VOCATIONAL EDUCATION;

CLINICAL COMPETENCE; DELIVERY OF HEALTH CARE; EDUCATION, PROFESSIONAL; ETHICS, CLINICAL; ETHICS, RESEARCH; HEALTH PERSONNEL; HUMANS; JUDGMENT; MORAL OBLIGATIONS; PATIENT CARE; PATIENTS; PERSONAL AUTONOMY; PHYSICIANS; QUALITY OF HEALTH CARE; SOCIAL JUSTICE; UNITED STATES;

EID: 84872415114     PISSN: 00930334     EISSN: 1552146X     Source Type: Journal    
DOI: 10.1002/hast.134     Document Type: Article

References (38)

1. Institute of Medicine, IOM Roundtable on Evidence-Based Medicine, The Learning Healthcare System: Workshop Summary, L. Olsen, D. Aisner, and J.M. McGinnis, eds. (Washington, D.C.: National Academies Press, 2007); Institute of Medicine, Committee on the Learning Health Care System in America, Best Care at Lower Cost: The Path to Continuously Learning Health Care in America, M. Smith, R. Saunders, L. Stuckhardt, and J.M. McGinnis, eds. (Washington, D.C.: National Academies Press, 2012), at S-11; C. Grossmann, W.A. Goolsby, L. Olsen, and J.M. McGinnis for the Institute of Medicine, Committee on the Learning Health Care Systems in America, Engineering a Learning Healthcare System: A Look at the Future. Workshop Summary, (Washington, D.C.: National Academies Press, 2011), at 1-2; L.M. Etheredge, "A Rapid-Learning Health System: What Would a Rapid-Learning Health System Look Like, and How Might We Get There?" Health Affairs 29, no. 10 (2007): w107-w118; C.P. Friedman, A.K. Wong.
2. Institute of Medicine, IOM Roundtable on Evidence-Based Medicine, The Learning Healthcare System, Olsen, Aisner, and McGinnis, eds., at 6, and see also 3.
3. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established in 1974 by the U.S. Congress and directed to "consider" the boundaries between research and accepted practice. The commission's basic statement of the "boundaries problem" occurs in the first section of the Belmont Report, as cited below; for the history of the commission's complex discussion of its congressional mandate, see T.L. Beauchamp and Y. Saghai, "The Foundations of the Distinction between Research and Practice," Theoretical Medicine and Bioethics 33 (2012): 45-56.
4. For thoughtful perspectives on the need to integrate "research and care," see E.A. Largent, S. Joffe, and F.G. Miller, "Can Research and Care Be Ethically Integrated?" Hastings Center Report 41, no. 4 (2011): 37-46.
5. Institute of Medicine, Committee on Quality of Health Care in America, To Err Is Human: Building a Safer Health System, L.T. Kohn, J.M. Corrigan, and M.S. Donaldson, eds. (Washington, D.C.: National Academies Press, 2000); R.M. Klevens et al., "Estimating Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002," Public Health Reports 122, no. 2 (2007): 160-66; U.S. Department of Health and Human Services, The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism (Washington, D.C.: U.S. Department of Health and Human Services, 2008); B. Winters et al., "Diagnostic Errors in the Intensive Care Unit: A Systematic Review of Autopsy Studies," BMJ Quality and Safety 12 (2012): 894-902; K. Reed and R. May, HealthGrades Patient Safety in American Hospitals Study (Denver, Colo.: Health Grades, 2011).
6. E.A. McGlynn et al., "The Quality of Health Care Delivered to Adults in the United States," New England Journal of Medicine 348 (2003): 2635-45.
7. Institute of Medicine, Committee on the Learning Health Care System in America, Best Care at Lower Cost, Smith et al., eds.
8. P. Pronovost et al., "An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU," New England Journal of Medicine 355 (2006): 2725-32; M.A. Baily, "Harming through Protection?" New England Journal of Medicine 358 (2008): 768-69.
9. D. Casarett, J.H.T. Karlawish, and J. Sugarman, "Determining When Quality Improvement Initiatives Should Be Considered Research: Proposed Criteria and Potential Implications," Journal of the American Medical Association 283 (2000): 2275-80; M.A. Baily, "Harming through Protection?".
10. M.A. Baily et al., "The Ethics of Using QI Methods to Improve Health Care Quality and Safety," Hastings Center Report Special Report 36, no. 4 (2006): S1-S40; Casarett, Karlawish, and Sugarman, "Determining When Quality Improvement Initiatives Should Be Considered Research"; U.S. Department of Health and Human Services, "ANPRM for Revision to Common Rule: Information Related to Advance Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule," Federal Register 76, no. 143 (2001): 44512-31.
11. For example, Best Care at Lower Cost discusses the rising cost and complexity of health care in the United States and argues that the U.S. health care system must become a learning system because it has "prominent shortcomings and inefficiencies that contribute to a large reservoir of missed opportunities, waste, and harm" that threaten "the health and economic security of Americans"; Institute of Medicine, Committee on the Learning Health Care System in America, Best Care at Lower Cost, Smith et al., eds., pp. 1-2 to 1-3. Similarly, Lynn Etheredge discusses the need to generate information from routine clinical encounters to improve the quality and value of health care delivered to patients; Etheredge, "A Rapid-Learning Health System.".
12. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, D.C.: Department of Health, Education, and Welfare, Publication OS 78-0012, 1978). The report was published in the Federal Register on April 18, 1979-the date now commonly but incorrectly cited as the original date of publication; http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.
13. P.R. Orszag and P. Ellis, "Addressing Rising Health Care Costs-A View from the Congressional Budget Office," New England Journal of Medicine 357 (2007): 1885-87; D. Leonhardt, "Making Health Care Better," New York Times Magazine, November 3, 2009.
14. See U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, February 18, 2011, http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_home/1204; see further http://www.healthit.gov/.
15. T. Percival, Medical Ethics; or a Code of Institutes and Precepts, Adapted to the Professional Conduct of Physicians and Surgeons (Manchester, U.K.: S. Russell, 1803). The book was first drafted in 1794 for hospitals and medical charities.
16. See Medical Professionalism Project, "Medical Professionalism in the New Millennium: A Physicians' Charter," Lancet 359, no. 9305 (2002): 520-22; P. Wagner et al., "Defining Medical Professionalism: A Qualitative Study," Medical Education 41, no. 3 (2007): 288-94; M.C. Beach et al., "What Does 'Respect' Mean? Exploring the Moral Obligation of Health Professionals to Respect Patients," Journal of General Internal Medicine 22 (2007): 692-95; L. Snyder et al., "American College of Physicians Ethics Manual, Sixth Edition," Annals of Internal Medicine 156 (2012): 73-104, at 75.
17. For the theory of rights, interests, and harms that informs this paragraph, see J. Feinberg, Rights, Justice, and the Bounds of Liberty (Princeton, N.J.: Princeton University Press, 1980), esp. 139-41, 149-55, 159-60, and 187; and J. Feinberg, Harm to Others, vol. 1 of The Moral Limits of the Criminal Law (New York: Oxford University Press, 1984), 3236.
18. See the essays in both F.G. Miller and A. Wertheimer, eds., The Ethics of Consent: Theory and Practice (New York: Oxford University Press, 2010); and J.S. Taylor, ed., Personal Autonomy: New Essays on Personal Autonomy and Its Role in Contemporary Moral Philosophy (Cambridge, U.K.: Cambridge University Press, 2005).
19. See M. Kottow, "The Battering of Informed Consent," Journal of Medical Ethics 30, no. 6 (2004): 565-69; R.M. Veatch, "From Nuremberg through the 1990s: The Priority of Autonomy," in The Ethics of Research Involving Human Subjects: Facing the 21st Century, ed. H.Y. Vanderpool (Frederick, Md.: University Publishing Group, 1996), 45-58; P.R. Wolpe, "The Triumph of Autonomy in American Bioethics: A Sociological View," in Bioethics and Society: Constructing the Ethical Enterprise, ed. R. de Vries and J. Subedi (Upper Saddle River, N.J.: Prentice Hall, 1998), 38-59; D. Callahan, "Autonomy: A Moral Good, Not a Moral Obsession," Hastings Center Report 14, no. 5 (1984): 40-42.
20. M. Powers and R. Faden, Social Justice: The Moral Foundations of Public Health and Health Policy (New York: Oxford University Press, 2006), 26-29; S. Buss, "Personal Autonomy," The Stanford Encyclopedia of Philosophy (Fall 2008 edition), ed. E.N. Zalta, at http://plato.stanford.edu/archives/fall2008/entries/personal-autonomy/.
21. A directly related point about the reasonableness and legitimacy of physicians proceeding with certain kinds of tests and treatment without specific authorization is made inS. Joffe and R. Truog, "Consent to Medical Care: The Importance of Fiduciary Context," in The Ethics of Consent, ed. F.G. Miller and A. Wertheimer (New York: Oxford University Press, 2010), 347-74, at 363.
22. E.J. Emanuel and S.D. Pearson, "Physician Autonomy and Health Care Reform," Journal of the American Medical Association 307 (2012): 367-68.
23. D.L. Sackett, "Evidence-Based Medicine," Seminars in Perinatology 21, no. 1 (1997): 3-5.
24. See National Commission for the Protection of Human Subjects, Belmont Report, Part C: Applications; R. Levine, Ethics and Regulation of Clinical Research, 2nd ed. (New Haven, Conn.: Yale University Press, 1988).
25. A.D. Lyerly, M.O. Little, and R. Faden, "The Second Wave: Toward Responsible Inclusion of Pregnant Women in Research," International Journal of Feminist Approaches to Bioethics 1, no. 2 (2008): 5-22.
26. R.K. Masters, R.A. Hummer, and D.A. Powers, "Educational Differences in U.S. Adult Mortality: A Cohort Perspective," American Sociological Review 77, no. 4 (2012): 548-72.
27. P. Tanabe et al., "Evaluation of a Train-the-Trainer Workshop on Sickle Cell Disease for ED Providers," Journal of Emergency Nursing (2011), doi:10.1016/j.jen.2011.05.010, published online September 2, 2011, http://www.jenonline.org/article/S0099-1767(11)00248-0/abstract; C. Haywood et al., "A Video-Intervention to Improve Clinician Attitudes Toward Patients with Sickle Cell Disease: The Results of a Randomized Experiment," Journal of General Internal Medicine 26, no. 5 (2011): 518-23.
28. Even those who do not support the social goal of just health care, as we have presented it, have reason to support the fifth obligation based on justice-related considerations having to do with the prevention of injustices in the conduct of research and clinical practice.
29. See Provincial Health Services Authority, Towards Reducing Health Inequities: A Health System Approach to Chronic Disease Prevention. A Discussion Paper (Vancouver, B.C., Canada: Population and Public Health, Provincial Health Services Authority, 2011), http://www.phsa.ca/NR/rdonlyres/0F19BDB8-2153-49D1-A214-E7D0D0B9DA3B/52162/TowardsReducingHealthInequitiesFinalDiscussionPape.pdf; U.S. Department of Health and Human Services, "Healthy People 2020: Framework," http://healthypeople.gov/2020/LHI/development.aspx, accessed December 3, 2012; World Health Organization, World Conference on Social Determinants of Health, "Rio Political Declaration on Social Determinants of Health," October 21, 2011, http://www.who.int/sdhconference/declaration/Rio_political_declaration.pdf.
30. American Medical Association, Council on Ethical and Judicial Affairs, Code of Medical Ethics: Current Opinions with Annotations (Chicago, Ill.: American Medical Association, 2006), secs. 9.011 and 9.14; G.R. Norman, S.I. Shannon, and M.L. Marrin, "The Need for Needs Assessment in Continuing Medical Education," British Medical Journal 328, no. 7446 (2004): 999-1001.
31. Medical Professionalism Project, "Medical Professionalism in the New Millenium"; American Medical Association, "Declaration of Professional Responsibility: Medicine's Social Contract with Humanity," adopted by the House of Delegates of the American Medical Association in San Francisco, California on December 4, 2001, http://www.ama-assn.org/resources/doc/ethics/decofprofessional.pdf; H.M. Swick, "Toward a Normative Definition of Medical Professionalism," Academic Medicine 75, no. 6 (2000): 615.
32. J. Rawls, A Theory of Justice (Cambridge, Mass.: Harvard University Press, 1971), pp. 246, 333.
33. D. Hume, "Of Suicide," in Essays: Moral, Political, and Literary, ed. E.F. Miller, 2nd ed. (Indianapolis, Ind.: Liberty Classics, 1987), 577-89.
34. Walter Stewart, personal communication, November 5, 2012.
35. G.O. Schaefer, E.J. Emanuel, and A. Wertheimer, "The Obligation to Participate in Biomedical Research," Journal of the American Medical Association 302, no. 1 (2009): 67-72; A.L. Caplan, "Is There a Duty to Serve as a Subject in Biomedical Research?" IRB: A Review of Human Research 6, no. 5 (1984): 1-5; J. Harris, "Scientific Research Is a Moral Duty," Journal of Medical Ethics 31 (2005): 242-48; R. Rhodes, "Rethinking Research Ethics," American Journal of Bioethics 5, no. 4 (2005): 7-28, esp. 9-11.
36. See Harris, "Scientific Research is a Moral Duty," 244-45, together with a defense and reformulation of the position in S. Chan and J. Harris, "Free Riders and Pious Sons: Why Science Research Remains Obligatory," Bioethics 23, no. 3 (2009): 161-71; and a criticism of Harris and Chan in I. Brassington, "Defending the Duty to Research," Bioethics 25, no. 1 (2011): 21-26.
37. David Orentlicher has proposed a much weaker but interesting obligation that adumbrates our position. In some limited contexts of research, he argues, doctors can legitimately make "treatment conditional on research participation"; D. Orentlicher, "Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research," Hastings Center Report 35, no. 5 (2005): 20-28.
38. R. Faden, "Stakeholder Views of Streamlined Informed Consent Options for CER Studies," abstract for a project at the Johns Hopkins Berman Institute of Bioethics, funded by the Patient-Centered Outcomes Research Institute, July 1, 2012 to June 31, 2014, http://www.pcori.org/assets/Faden-Ruth1.pdf.