The Research-Clinical Practice Distinction, Learning Health Systems, and Relationships

Hastings Center Report

Volumn 43, Issue 5, 2013, Pages 41-47

  Brody, Howard ^a   Miller, Franklin G ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CONFLICT OF INTEREST; DOCTOR PATIENT RELATION; ETHICS; HEALTH SERVICES RESEARCH; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; LEARNING; MEDICAL RESEARCH; PROFESSIONAL STANDARD; RISK FACTOR;

BIOMEDICAL RESEARCH; CLINICAL PROTOCOLS; CONFLICT OF INTEREST; DATA COLLECTION; ETHICS COMMITTEES, RESEARCH; HEALTH SERVICES RESEARCH; HUMANS; INFORMED CONSENT; LEARNING; PHYSICIAN-PATIENT RELATIONS; RISK FACTORS;

EID: 84884934088     PISSN: 00930334     EISSN: 1552146X     Source Type: Journal    
DOI: 10.1002/hast.199     Document Type: Article

References (19)

1. P. Pronovost, D. Needham, S. Berenholtz, et al., "An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU, " New England Journal of Medicine 355 (2006): 2725-32.
2. M. A. Baily, "Harming through Protection?, " New England Journal of Medicine 358 (2008): 768-69.
3. F. G. Miller and E. J. Emanuel, "Quality-Improvement Research and Informed Consent, " New England Journal of Medicine 358 (2008):765-67.
4. R. R. Faden, N. E. Kass, S. N. Goodman, et al., "An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics, " Hastings Center Report 43, no. 1 (2013): S16-S27; N. E. Kass, R. R. Faden, S. N. Goodman, et al., "The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight, " Hastings Center Report 43, no. 1 (2013): S4-S15.
5. 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, DC: Department of Health, Education, and Welfare, Publication OS 78-0012, 1978); http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html; F. G. Miller, "Revisiting the Belmont Report: The Ethical Significance of the Distinction between Clinical Research and Medical Care, " American Philosophical Association Newsletter on Philosophy and Medicine 5, no. 20 (2006): 10-14.
6. H. K. Beecher, "Ethics and Clinical Research, " New England Journal of Medicine 274 (1966): 199460; F. G. Miller, "Homage to Henry Beecher (1904-1976), " Perspectives in Biology and Medicine 55 (2012): 218-29.
7. R. J. Levine, "Clarifying the Concepts of Research Ethics, " Hastings Center Report 9, no. 3 (1979): 21-26; F. G. Miller and H. Brody, "A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials, " Hastings Center Report 33, no. 3(2003): 19-28.
8. Kass et al., "Research-Treatment Distinction."
9. Ibid., at S6.
10. Ibid., at S7.
11. 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.
12. H. Brody and F. G. Miller, "The Clinician-Investigator: Unavoidable but Manageable Tension, " Kennedy Institute of Ethics Journal 13 (2003): 329-46.
13. Kass et al., "Research-Treatment Distinction, " at S7.
14. Ibid., at S8.
15. L. T. Kohn, J. M. Corrigan, and M. S. Donaldson, eds., To Err Is Human: Building a Safer Health System (Washington, DC: National Academies Press, 2000).
16. L. R. Churchill, "Physician-Investigator/Patient-Subject: Exploring the Logic and the Tension, " Journal of Medicine and Philosophy 5 (1980): 215-24.
17. A. R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998), 125-65.
18. Largent, "Can Research and Care."
19. S. Joffe, "Revolution or Reform in Human Subjects Research Oversight, " Journal of Law, Medicine & Ethics 40 (2013): 922-29.