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  • Print publication year: 2010
  • Online publication date: March 2012

33 - Quality improvement initiatives: when is quality improvement actually a form of human subjects research?

from 4 - Research and publication


1 Suarez, J.I., Shannon, L., Zaidat, O.O., et al. (2004). Effect of human albumin administration on clinical outcome and hospital cost in patients with subarachnoid hemorrhage. J Neurosurg, 100, 585–90.
2 Heros, R. (2004). Fluid management. J Neurosurg, 100, 581–2.
3 Rie, M.A., Fahy, B.G., and Kofke, W.A. (2005). Human serum albumin. J Neurosurg, 101, 564–6; author reply 566.
4* Donabedian, A. (1980). Definition of Quality and Approaches to Its Assessment. Ann Arbor, Michigan: Health Administration Press.
5* To Err Is Human. (1999). A Report of the Institute of Medicine. Washington, DC: National Academy Press.
6 Bellin, E. and Dubler, N.N. (2001). The quality improvement–research divide and the need for external oversight. Am J Public Health, 91(9), 1512–17.
8* Bosk, C.L., Goeschel, C.A., and Pronovost, P.J. (2009). The art of medicine: reality for checklists. Lancet, 374, 444–5.
9 Gawande, A. (2007). A life saving checklist. Opinion, New York Times December 30. Available at
10* Kofke, W.A. and Rie, M.A. (2003). Research ethics and law of healthcare system quality improvement: The conflict of cost containment and quality. Crit Care Med, 31(Suppl), S143–52.
11* Baily, M.A., Bottrell, M., Lynn, J., and Jennings, B. (2006). The ethics of using QI methods to improve quality and safety. Hastings Cent Rep, 36, S1–40.
13 Haig, S. Electronic records: will they really cut costs?.,8599,1883002,00.html/.

Further reading

Childress, J.F., Meslin, E.M., and Shapiro, H.T. (2005). Belmont Revisited. Washington, DC: Georgetown University Press (p.vii).
Grady, C. (2007). Quality improvement and ethical oversight. Ann Int Med, 146(9), 680–1.
Miller, F. and Emanuel, E. (2008). Quality improvement research and informed consent. NEJM, 358(8), 765–7.
Rie, M.A. and Kofke, W.A. (2007). Non-therapeutic quality improvement: The conflict of organizational ethics and societal rule of law. Crit Care Med, 35 (Suppl), S66–84.
Rodwin, M.A. (1993). Medicine, Money and Morals: Physicians’ Conflicts of Interest. New York:Oxford University Press.
Tapp, L., Edwards, A., Elwyn, G., et al. (2010). Quality improvement in general practice: enabling general practitioners to judge ethical dilemmas. J Med Ethics, 36(3), 184–8.
US Department of Health Education and Welfare. (1979). Protection of human subjects: Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. Fed Reg, 44, 23192–7.