Ethical Oversight of Research on Patient Care
The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinic...
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| Published in | The Hastings Center report Vol. 43; no. s1; pp. S2 - S3 |
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| Main Authors | , |
| Format | Journal Article |
| Language | English |
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United States
Blackwell Publishing Ltd
01.01.2013
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| Abstract | The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void. |
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| AbstractList | The Institute of Medicine has called on health care leaders to transform their health systems into "learning health care systems," capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void. [PUBLICATION ABSTRACT] The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void . The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void. |
| Author | Bonham, Ann C. Solomon, Mildred Z. |
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| Cites_doi | 10.1002/j.1552-146X.2011.tb00123.x 10.1080/15265161.2010.494230 10.1377/hlthaff.2010.0790 10.1353/hcr.2006.0054 |
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| Notes | ArticleID:HAST132 ark:/67375/WNG-TMF8JDNJ-D istex:1460EBDE32E60BCD425DA195D621120612862410 Ethical Oversight of Learning Health Care Systems Mildred Z. Solomon and Ann C. Bonham, “Ethical Oversight of Research on Patient Care,” SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 14 content type line 23 ObjectType-Editorial-2 ObjectType-Commentary-1 |
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| References | 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; M.A. Baily, "Harming through Protection?" New England Journal of Medicine 358 (2008): 768-69. 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); C. Grossmann, W.A. Goolsby, L. Olsen, and J.M. McGinnis for the Institute of Medicine, Committee on the Learning Health Care System in America, Engineering a Learning Healthcare System: A Look at the Future. Workshop Summary, (Washington, D.C.: National Academies Press, 2011). 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). M.Z. Solomon, "The Ethical Urgency of Advancing Implementation Science," American Journal of Bioethics 10, no. 8 (2010): 31-32. A.C. Bonham and M.Z. Solomon, "Moving Comparative Effectiveness Research into Practice: Implementation Science and the Role of Academic Medicine," Health Affairs 29, no. 1 (2010): 1901-905; E.C. Rich, A.C. Bonham, and D.G. Kirch, "The Implications of Comparative Effectiveness Research for Academic Medicine," Academic Medicine 86, no. 6 (2011): 684-88. 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. Institute of Medicine, Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care, B.D. Smedley, A.Y. Stith, and A.R. Nelson, eds. (Washington, D.C.: National Academies Press, 2003); 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; 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). 2009 2011; 41 2007 2010; 10 2003 2010; 29 2006; 36 1978 e_1_2_2_4_1 e_1_2_2_6_1 e_1_2_2_7_1 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (e_1_2_2_5_1) 1978 Institute of Medicine, IOM Roundtable on Evidence‐Based Medicine (e_1_2_2_2_1) 2007 e_1_2_2_3_1 Institute of Medicine, Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care (e_1_2_2_1_1) 2003 e_1_2_2_9_1 e_1_2_2_8_1 |
| References_xml | – reference: M.Z. Solomon, "The Ethical Urgency of Advancing Implementation Science," American Journal of Bioethics 10, no. 8 (2010): 31-32. – reference: 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; M.A. Baily, "Harming through Protection?" New England Journal of Medicine 358 (2008): 768-69. – reference: Institute of Medicine, Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care, B.D. Smedley, A.Y. Stith, and A.R. Nelson, eds. (Washington, D.C.: National Academies Press, 2003); 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; 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). – reference: 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); C. Grossmann, W.A. Goolsby, L. Olsen, and J.M. McGinnis for the Institute of Medicine, Committee on the Learning Health Care System in America, Engineering a Learning Healthcare System: A Look at the Future. Workshop Summary, (Washington, D.C.: National Academies Press, 2011). – reference: 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. – reference: A.C. Bonham and M.Z. Solomon, "Moving Comparative Effectiveness Research into Practice: Implementation Science and the Role of Academic Medicine," Health Affairs 29, no. 1 (2010): 1901-905; E.C. Rich, A.C. Bonham, and D.G. Kirch, "The Implications of Comparative Effectiveness Research for Academic Medicine," Academic Medicine 86, no. 6 (2011): 684-88. – reference: 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). – year: 2009 – volume: 41 start-page: 37 issue: 4 year: 2011 end-page: 46 article-title: Can Research and Care Be Ethically Integrated? publication-title: Hastings Center Report – year: 1978 – volume: 29 start-page: 1901 issue: 1 year: 2010 end-page: 905 article-title: Moving Comparative Effectiveness Research into Practice: Implementation Science and the Role of Academic Medicine publication-title: Health Affairs – year: 2007 – volume: 36 start-page: S1 issue: 4 year: 2006 end-page: S40 article-title: The Ethics of Using QI Methods to Improve Health Care Quality and Safety publication-title: Hastings Center Report Special Report – year: 2003 – volume: 10 start-page: 31 issue: 8 year: 2010 end-page: 32 article-title: The Ethical Urgency of Advancing Implementation Science publication-title: American Journal of Bioethics – ident: e_1_2_2_4_1 doi: 10.1002/j.1552-146X.2011.tb00123.x – ident: e_1_2_2_7_1 doi: 10.1080/15265161.2010.494230 – volume-title: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research year: 1978 ident: e_1_2_2_5_1 – ident: e_1_2_2_6_1 – volume-title: The Learning Healthcare System: Workshop Summary year: 2007 ident: e_1_2_2_2_1 – ident: e_1_2_2_8_1 doi: 10.1377/hlthaff.2010.0790 – volume-title: Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care year: 2003 ident: e_1_2_2_1_1 – ident: e_1_2_2_9_1 – ident: e_1_2_2_3_1 doi: 10.1353/hcr.2006.0054 |
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| SubjectTerms | Clinical medicine Clinical Trials as Topic - ethics Data collection Ethics, Research Health care industry Human Experimentation - ethics Humans Medical ethics Moral Obligations National Academies of Science, Engineering, and Medicine (U.S.) Health and Medicine Division Organizational learning Patient Care - ethics Quality of care Research Subjects United States |
| Title | Ethical Oversight of Research on Patient Care |
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