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Learning to Regulate Learning Healthcare Systems

  • JAN PIASECKI and VILIUS DRANSEIKA

Abstract:

It is commonplace to observe that science often outstrips the ability of society to monitor, supervise and regulate it. A recent challenge in this regard concerns Learning Healthcare Systems, an initiative to collect data and test hypotheses across clinical settings, and therefore to a larger degree than before. Some argue that the line between research and clinical practice is becoming blurred, and that existing regulation seems to obstruct low risk research. They propose the creation of a new ethical framework for Learning Healthcare Systems, to speed up research. This paper opposes that view, and argues that Learning Healthcare Systems do not blur or remove the line between research and practice, and will not result in a single set of regulations for all kinds of biomedical research. The authors suggest that a large proportion of Learning Healthcare System activities resemble public health surveillance to a significant extent. Therefore, they propose that these activities should be organized in accordance with the same ethical principles as public health surveillance, specifically that Learning Healthcare Systems should rest on the principles of comprehensiveness, transparency, and public accountability.

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Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

Footnotes

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Acknowledgements: This project was funded by the National Science Centre, Poland, 2015/19/D/HS1/00991. We thank Phyllis Zych Budka for linguistic edits.

This section features original work on ethical, legal, policy, and social aspects of the use of computing and information technology in health, biomedical research, and the health professions. For submissions, contact Kenneth Goodman at: kgoodman@med.miami.edu

Footnotes

References

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Notes

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3. Abernethy, AP, Etheredge, LM, Ganz, PA, Wallace, P, German, RR, Neti, C, et al. Rapid-learning system for cancer care. Journal of Clinical Oncology 2010;28(27):4268–74.

4. Institute of Medicine. Integrating Research and Practice. Health System Leaders Working Toward High Value Care. Workshop Summary; Washington D.C., The National Academies Press; 2015, at xi.

5. Friedman CP, Macy J. Toward Complete & Sustainable Learning Systems; 2014; avaiable at: https://medicine.umich.edu/sites/default/files/2014_12_08-Friedman-IOM%20LHS.pdf (last accessed 16 Aug 2018); Morain, SR, Kass, NE, Grossmann, C. What allows a health care system to become a learning health care system: Results from interviews with health system leaders. Learning Health Systems. 2017;1(1):e10015– doi: 10.1002/lrh2.10015 .

6. See note 1, Foley 2015.

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8. See note 7, Beauchamp 2011.

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14. See note 12, Kass 2013.

15. See note 12, Kass 2013.

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18. Faden, RR, Kass, NE, Goodman, SN, Pronovost, P, Tunis, S, Beauchamp, TL. An ethics framework for a learning health care system: A departure from traditional research ethics and clinical ethics. Hastings Center Report 2013;Spec No:S1627.

19. See note 18, Faden 2013.

20. Elwyn, G, Frosch, D, Thomson, R, Joseph-Williams, N, Lloyd, A, Kinnersley, P, et al. Shared decision making: A model for clinical practice. Journal of General Internal Medicine 2012;27(10):1361–7.

21. See note 18, Faden 2013.

22. 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., 1979.

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24. Kim, SY. Ethical issues in pragmatic trials of “standard-of-care” interventions in learning health care systems. Learning Health Systems 2018;2(1).

25. Brody, H, Miller, FG. The clinician-investigator: Unavoidable but manageable tension. Kennedy Institute Ethics Journal 2003;13(4):329–46.

26. Rothstein, MA. Rethinking the meaning of public health. The Journal of Law, Medicine & Ethics 2002;30(2):144–9.

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28. Gostin, LO, Stone, L. Health of the people: The highest law. In: Dawson, A, Verweij, M, editors. Ethics, Prevention, and Public Health. Issues in Biomedical Ethics. Oxford: Oxford University Press; 2007:5977.

29. Thacker, SB, Berkelman, RL. Public health surveillance in the United States. Epidemiologic Review 1988;10:164–90.

30. Fairchild, AL, Bayer, R. Public health. Ethics and the conduct of public health surveillance. Science 2004;303(5658):631–2. Willison, DJ, Ondrusek, N, Dawson, A, Emerson, C, Ferris, LE, Saginur, R, et al. What makes public health studies ethical? Dissolving the boundary between research and practice. BMC Medical Ethics 2014;15(1):61.

31. Fairchild, AL. Dealing with Humpty Dumpty: Research, practice, and the ethics of public health surveillance. Journal of Law Medicine and Ethics 2003;31(4):615–23.

32. See note 31, Fairchild 2003, Fairchild, AL, Johns, DM. Beyond bioethics: Reckoning with the public health paradigm. American Journal of Public Health 2012;102(8):1447–50.

33. Jonas, H. Philosophical reflections on experimenting with human subjects. Daedalus 1969:219–47.

34. Holland, S. Public Health Ethics. Cambridge: John Wiley & Sons; 2015.

35. See note 28, Gostin 2007.

36. See note 13, Wachter 2015.

37. Piasecki, J, Dranseika, V, Waligora, M. Should epidemiological studies be subject to an ethics review? Public Health Ethics 2018;11(2):213–22.

Acknowledgements: This project was funded by the National Science Centre, Poland, 2015/19/D/HS1/00991. We thank Phyllis Zych Budka for linguistic edits.

This section features original work on ethical, legal, policy, and social aspects of the use of computing and information technology in health, biomedical research, and the health professions. For submissions, contact Kenneth Goodman at:

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Cambridge Quarterly of Healthcare Ethics
  • ISSN: 0963-1801
  • EISSN: 1469-2147
  • URL: /core/journals/cambridge-quarterly-of-healthcare-ethics
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