Learning Health System — Moving from Ethical Frameworks to Practical Implementation

Institute of Medicine, Roundtable on Evidence-Based Medicine, L. A. Olsen , D. Aisner , and J. M. McGinnis , eds., The Learning Healthcare System: Workshop Summary (Washington, DC: National Academies Press, 2007), available at <http://www.ncbi.nlm.nih.gov/books/NBK53484/> (last visited August 6, 2019).

See id.

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See id.

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N. E. Kass et al., “The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight,” Hastings Center Report 43, no. S1 (2013): S4-S15.

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See Kass, supra note 13.

See id.

N. E. Kass and R. R. Faden , “Ethics and Learning Health Care: The Essential Roles of Engagement, Transparency, and Accountability,” Learning Health Systems 2, no. 4 (2018): e10066.

See id.

See id.

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See Kass, supra note 18.

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See id.

M. S. McCoy et al., “Patient and Public Involvement: Two Sides of the Same Coin or Different Coins Altogether?” Bioethics 33, no. 6 (2019): 708-715.

S. R. Morain , “Whom to Engage in Patient-Engaged Research? Reflection on Selection,” Hastings Center Report 48, no. 5 (2018): 35-36; M.A. Majumder et al., “The Role of Participants in a Medical Information Commons,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 51-61.

M. K. Cho et al., “Attitudes toward Risk and Informed Consent for Research on Medical Practices: A Cross-Sectional Survey,” Annals of Internal Medicine 162, no. 10 (2015): 690-696; N. Kass et al., “Alternative Consent Models for Comparative Effectiveness Studies: Views of Patients from Two Institutions,” AJOB Empirical Bioethics 7, no. 2 (2016): 92-105; S.E. Kraft et al., “A Comparison of IRB and Patient Views on Consent for Research on Medical Practices,” Clinical Trials 13, no. 5 (2016): 555-565; S.R. Morain et al., “Stakeholder Perspectives Regarding Alternate Approaches to Informed Consent for Comparative Effectiveness Research,” Learning Health Systems 2, no. 2 (2018): e10047.

M. M. Mello and L. E. Wolf , “The Havasupai Indian Tribe Case: Lessons for Research Involving Stored Biological Samples,” New England Journal of Medicine 363, no. 3 (2010): 204–207; M. H. Lewis , “Lessons from the Residual Newborn Screening Dried Blood Sample Litigation,” Journal of Law, Medicine & Ethics 43, no. S1 (2015): 32–35

See Largent, supra note 12.

See Kass, supra note 18.

See id.

E. A. Balas and S. A. Boren , “Managing Clinical Knowledge for Health Care Improvement,” in J. Bemmel and A. T. McCray , eds., Yearbook of Medical Informatics 2000: Patient-Centered Systems (Stuttgart, Germany: Schattauer Verlagsgesellschaft mbH, 2000): 65–70.

See Kass, supra note 18.

S. R. Morain , N. E. Kass , and R. R. Faden , “Learning is Not Enough: Earning Institutional Trustworthiness through Knowledge Translation,” American Journal of Bioethics 18, no. 4 (2018): 31-34.

See James, supra note 7.

A. L. McGuire et al., “Importance of Participant-centricity and Trust for a Sustainable Medical Information Commons,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 12-20.