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Is ‘Quality Science’ Human Subjects Research?

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Surgical Quality Improvement

Part of the book series: Success in Academic Surgery ((SIAS))

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Abstract

Physicians have an ethical obligation to their patients, institutions, and community to provide the highest quality of care possible. In the past 15 years, beginning with the Institute of Medicine’s To Err is Human report (Kohn et al. To err is human: building a safer health system. Washington, DC: National Academies Press, 2000), Quality Improvement (QI) in surgery has been prioritized by national organizations, including the Centers for Medicare & Medicaid Services, the Center for Disease Control, the American College of Surgeons, and the Accreditation Council for Graduate Medical Education (ACGME). The aim of QI projects is to evaluate the quality of perioperative surgical care and design projects that modify systems and behavior within individual institutions to produce better patient outcomes.

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References

  • Baily MA, et al. The ethics of using QI methods to improve health care quality and safety. Hastings Cent Rep. 2006;36(4):S1–40.

    Article  PubMed  Google Scholar 

  • Davidoff F, Batalden P. Toward stronger evidence on quality improvement. Draft publication guidelines: the beginning of a consensus project. Qual Saf Health Care. 2005;14(5):319–25.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Davidoff F, et al. Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project. BMJ. 2009;338:a3152.

    Article  PubMed  PubMed Central  Google Scholar 

  • Finkelstein JA, et al. Oversight on the borderline: quality improvement and pragmatic research. Clin Trials. 2015;12(5):457–66.

    Article  PubMed  PubMed Central  Google Scholar 

  • Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: a practical approach to ethical decisions in clinical medicine. 8th ed. New York: McGraw-Hill Education; 2015.

    Google Scholar 

  • Kohn LT, Corrigan JM, Donaldson MS, editors. To err is human: building a safer health system. Washington, DC: National Academies Press; 2000.

    Google Scholar 

  • Lynn J, et al. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007;146(9):666–73.

    Article  PubMed  Google Scholar 

  • McGlynn EA, et al. The quality of health care delivered to adults in the United States. N Engl J Med. 2003;348(26):2635–45.

    Article  PubMed  Google Scholar 

  • Millenson ML. The silence. Health Aff (Millwood). 2003;22(2):103–12.

    Article  Google Scholar 

  • Raval MV, et al. Distinguishing QI projects from human subjects research: ethical and practical considerations. Bull Am Coll Surg. 2014;99(7):21–7.

    PubMed  Google Scholar 

  • Services U.S.D.o.H.H. Code of federal regulations. Title 45: public welfare, part 46: protection of human subjects 2009 January 15, 2010. Cited 15 Feb 2016. Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

  • Weiss KB, Wagner R, Nasca TJ. Development, testing, and implementation of the ACGME Clinical Learning Environment Review (CLER) program. J Grad Med Educ. 2012;4(3):396–8.

    Article  PubMed  PubMed Central  Google Scholar 

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Correspondence to Peter Angelos MD, PhD .

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© 2017 Springer International Publishing Switzerland

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Applewhite, M.K., Angelos, P. (2017). Is ‘Quality Science’ Human Subjects Research?. In: Kelz, R., Wong, S. (eds) Surgical Quality Improvement. Success in Academic Surgery. Springer, Cham. https://doi.org/10.1007/978-3-319-23356-7_10

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  • DOI: https://doi.org/10.1007/978-3-319-23356-7_10

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-23355-0

  • Online ISBN: 978-3-319-23356-7

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