Learning health care systems are designed to promote "learning while treating and treating while learning." Should researchers, clinicians, or HRPP personnel have any special concerns or responsibilities as part of such a system?
Elaborate on your response to this question by examining how it applies “Drowning Children”, in the attached PDF “Largent-2019”
Of Drowning Children and Doubtful Analogies 26 HASTINGS CENTER REPORT July-August 2019 In an article in this issue of the Hastings Center Report, James Sabin and his colleagues ask how we should we think about “bystander ethics” in a learning health organization.1 At the outset, I must reject the label “by- stander ethics.” As understood by Sabin et al., the “by- standers” here are the investigators actively designing and conducting interventional research within a learning health organization, but they are not bystanders at all. To conceive of them as passive parties creates problems in the resulting ethical reasoning that I will unpack below. Nomenclature aside, I agree with Sabin and his colleagues that it is important to ask what responsibility investiga- tors in a learning health organization have to patients when research—particularly research of which patients might be unaware—illuminates problematic aspects of the patients’ care. Sabin and his colleagues were confronted by this ques- tion in the midst of designing a randomized controlled trial, IMPACT-AFib (Implementation of a Random- ized Controlled Trial to Improve Treatment with Oral AntiCoagulants in Patients with Atrial Fibrillation). IMPACT-AFib sought to determine if an educational in- tervention targeted at patients with atrial fibrillation and their clinicians reduces underuse of oral anticoagulants. The researchers also considered whether the study was Anticoagulant Therapy in Patients with Atrial Fibrillation (Review),” Cochrane Database of Systematic Reviews 4, no. CD008600 (2017): 3. 11. T. M. Scanlon, What We Owe to Each Other (Cambridge, MA: Belknap Press of Harvard University Press, 1998), 224-26. 12. P. Singer, “Famine, Affluence, and Mortality,” Philosophy and Public Affairs 1, no. 3 (1972): 229-43, at 231. 13. T. A. Lieu and R. Platt, “Applied Research and Development in Health Care—Time for a Frameshift,” New Eng- land Journal of Medicine 376, no. 8 (2017): 710-13. 14. J. E. Sabin and D. Cochran, “Con- fronting Trade-offs in Health Care: Harvard Pilgrim Health Care’s Organizational Ethics Program,” Health Affairs 26, no. 4 (2007): 1129-34. 15. S. Y. H. Kim, “Clinical Trials without Consent?,” Perspectives in Biology and Medi- cine 59, no. 1 (2016): 132-46. 16. M. P. Kerlin et al., “A Randomized Trial of Nighttime Physician Staffing in an Intensive Care Unit,” New England Journal of Medicine 368 (2013): 2201-9. 17. Kim, “Clinical Trials without Con- sent?,” 140. 18. L. Shepherd and R Macklin, “Ero- sion of Informed Consent in U.S. Re- search,” Bioethics 33 (2019): 4-12. 19. S. Y. H. Kim and F. G. Miller, “In- formed Consent for Pragmatic Trials—the Integrated Consent Model,” New England Journal of Medicine 370, no. 8 (2014): 769-72. 20. E. Kodish, J. D. Lantos, and M. Siegler, “Ethical Considerations in Ran- domized Controlled Clinical Trials,” Cancer 65, supplement (1990): 2400-2404. 21. Institute of Medicine, To Err is Hu- man: Building a Safer Health System (Wash- ington, DC: National Academies Press, 2000). 22. Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century (Washington, DC: National Academies Press, 2001). 23. A. Gutmann, “The Bioethics Com- mission on Incidental Findings,” Science 342 (2013): 1321-23. 24. H. S. Richardson and L. Belsky, “The Ancillary-Care Responsibilities of Medical Researchers,” Hastings Center Report 34, no. 1 (2004): 25-33, at 29. 25. Faden et al., “An Ethics Framework for a Learning Health Care System.” 26. American Medical As- sociation, “AMA Principles of Medical Ethics,” 2001, https://www.ama- assn.org/about/publications-newsletters/ ama-principles-medical-ethics. 27. E. A. Largent, S. Joffe, and F. G. Miller, “Can Research and Care Be Ethi- cally Integrated?,” Hastings Center Report 41, no. 4 (2011): 37-46. 28. A. L. Simpkin and R. M. Schwartz- stein, “Tolerating Uncertainty—the Next Medical Revolution?,” New England Journal of Medicine 375 (2016): 1713-15. 29. Faden et al., “An Ethics Framework for a Learning Health Care System,” S25. Other Voices Of Drowning Children and Doubtful Analogies by EMILY A. LARGENT Emily A. Largent, “Of Drowning Children and Doubtful Analogies,” Hast- ings Center Report 49, no. 4 (2019): 26-28. DOI: 10.1002/hast.1032 July-August 2019 HASTINGS CENTER REPORT 27 reminiscent of the Tuskegee experiment, the U.S. Pub- lic Health Service’s infamous study of untreated syphilis.2 (Given the contempt in which Tuskegee is held, the anal- ogy to Tuskegee is striking; given the facts, it is rightly rejected.) As those overseeing the IMPACT-AFib trial saw it, the ethical problem was that, whereas some patients with atrial fibrillation would receive education about the im- portance of anticoagulation, others would not. Though Sabin and his colleagues repeatedly stress that the edu- cational intervention under study in IMPACT-AFib was in equipoise, they also seem to labor under a therapeutic misestimation. If the study was in equipoise, then there was no scientific justification for believing that patients in the active group would be better off than those in the control group. The very aim of the trial was to make that determination. Yet, worried about harm that might befall patients in the control group and fearing that they would be negli- gent bystanders if they knew these patients were at risk and did nothing, the IMPACT-AFib investigators ad- opted a “workaround.” In the original IMPACT-AFib de- sign, the investigators proposed to prospectively observe a “usual care” control group. In the “workaround,” the investigators instead identified a “delayed-intervention” group without ascertaining the group members’ antico- agulation status and with a plan to store the relevant data and then retrospectively “trace” their care over the study period. The “workaround,” I suggest, was not a solution to the negligent bystander problem identified by the IM- PACT-AFib team. Nor was it a solution to the problem as I would alternatively frame it—how to address instances of suboptimal patient care identified through research within learning health organizations. To see why, we must consider two drowning children. Sabin and his colleagues use Peter Singer’s classic es- say, “Famine, Affluence, and Morality”3 to motivate the moral problem at the core of their essay. They recount Singer’s persuasive claim that if you (a bystander) see a child drowning in a shallow pond, you should wade in and save the child even if your clothes will get muddied. Then, after describing the IMPACT-AFib “workaround,” they claim that this revised trial design was “analogous to choosing not to walk past or look at a shallow pond in which a child might drown.”4 Let us accept as true the premise implicit in the au- thors’ analogy: that we do not generally have an obliga- tion to look for children who might be drowning. This is at least superficially plausible. Most days, on my way to work, I cross a bridge over the Schuylkill River, a body of water in which a child might plausibly drown. Surely, few would argue that I have a moral responsibility to scan the water vigilantly as I walk to work, and none would argue that I have a moral responsibility to always walk to work over the bridge lest a child in the water need rescuing. Even if we accept this premise as true, however, the anal- ogy fails to support the argument being made in favor of the “workaround.” Sabin and his colleagues provide robust evidence at the outset of their essay to demonstrate that oral antico- agulants are underused in the treatment of patients with atrial fibrillation. In light of their own evidence, they can- not claim to be averting their eyes from a pond where a child might drown. Through their research, they know that some patients are receiving substandard care and will come to harm (even if they do not know precisely which ones). Though nameless to the investigators, these patients are, of course, real individuals. And, as Singer himself points out in “Famine, Affluence, and Morality,” it “makes no moral difference whether the person I can help is a neighbor’s child ten yards from me” or someone “whose name I shall never know.” The IMPACT-AFib “workaround” is more accurately analogized to knowing that a child is drowning and averting your eyes to ensure that your clothes do not get soiled. Unfortunately, what saves one’s clothes does not always satisfy one’s moral obligations. This brings us to another drowning child: a six-year- old in his evening bath. This child inhabits another classic essay, James Rachels’s “Active and Passive Euthanasia.”5 Rachels describes two men—Smith and Jones—both of whom stand to gain a large inheritance if the boy in the bath dies. Whereas Smith actively pushes the child under the water, Jones passively watches as the child succumbs to it. From a moral point of view, Rachels argues, Jones is no better than Smith. Both men acted from the same motive, and both had the same end in view. Similarly, from a moral point of view, IMPACT-AFib in its revised form is no better than it was as originally proposed. The “workaround” was a legerdemain. It made no material difference for the patients: the delayed-inter- vention group continued to serve as the controls, and the outcomes of interest continued to be anticoagulant use, stroke, and bleeding. Same motive. Same end. The ma- jor difference was that the investigators deliberately kept themselves from knowing the anticoagulation status of those in the delayed-intervention group, something that was knowable by them. If willful blindness is a successful strategy for avoiding moral responsibility, one should conclude that the “work- around” was preferable to the original IMPACT-AFib design. But does one really want to say that? I think not. Imagine I was crossing the Schuylkill River and knew a child was drowning but