Ethics and Surgical Innovation

  • Maria S. AltieriEmail author
  • Aurora D. Pryor


Innovation is important in medicine and surgery, as new technologies and techniques have immensely improved patient care. However, innovation has required collaboration between physicians, industry, engineers, investors, and entrepreneurs, among others. Because of these relations, ethical conflicts can exist. The following chapter will review the ethical challenges that surgeons face today when confronted to innovative procedures or developments.


Ethics Innovation in surgery 


  1. 1.
    Riskin DJ, Longaker MT, Gertner M, Krummel TM. Innovation in surgery: a historical perspective. Ann Surg. 2006;244(5):686–93.CrossRefGoogle Scholar
  2. 2.
    Spodick DH. Numerators without denominators. There is no FDA for the surgeon. JAMA. 1975;232(1):35–6.CrossRefGoogle Scholar
  3. 3.
    Love JW. Drugs and operations. Some important differences. JAMA. 1975;232(1):37–8.CrossRefGoogle Scholar
  4. 4.
    Litynskic GS. Erich Mühe and the rejection of laparoscopic cholecystectomy (1985): a surgeon ahead of his time. JSLS. 1998;2(4):341–6.Google Scholar
  5. 5.
    Truven Health Analytics (Thomson/Solucient), USA procedure volumes 2014 National Data. Ann Arbor.Google Scholar
  6. 6.
    Strasburg SM. Single incision laparoscopic cholecystectomy and the introduction of innovative surgical procedures. Ann Surg. 2012;256(1):2.Google Scholar
  7. 7.
    McKneally MF, Daar AS. Introducing new technologies: protecting subjects of surgical innovation and research. World J Surg. 2003;27:930–7.CrossRefGoogle Scholar
  8. 8.
    Steinbrook R. Improving protection for research subjects. N Engl J Med. 2004;346:1425–8.CrossRefGoogle Scholar
  9. 9.
    Roy DL, Black PM, McPeek B. Ethical principles in research. In: Principles and practice of research: strategies for surgical investigation. New York: Springer-Verlag; 1991.Google Scholar
  10. 10.
    Biffl WL, Spain DA, Reitsma AM, Society of University Surgeons Surgical Innovations Project Team, et al. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg. 2008;206(6):1204–9.CrossRefGoogle Scholar
  11. 11.
    Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg. 2002;194(6):792–801.CrossRefGoogle Scholar
  12. 12.
    Rogers WA, Lotz M, Hutchison K, Pourmoslemi A, Eyers A. Identifying surgical innovation: a qualitative study of surgeons’ views. Ann Surg. 2014;259(2):273–8.CrossRefGoogle Scholar
  13. 13.
    Rutan RL, Deitch EA, Waymack JP. Academic surgeons’ knowledge of Food and Drug Administration regulations for clinical trials. Arch Surg. 1997;132:94–8.CrossRefGoogle Scholar
  14. 14.
    Broekman ML, Carrière ME, Bredenoord AL. Surgical innovation: the ethical agenda: a systematic review. Medicine (Baltimore). 2016;95(25):e3790.CrossRefGoogle Scholar
  15. 15.
    Sundaram V, Vermana G, Bhayani SB. Institutional review board approval and innovation in urology: current practice and safety issues. BJU Int. 2014;113(2):343–7.CrossRefGoogle Scholar
  16. 16.
    Lieberman I, Hemdon J, Hahn J, Fins JJ, Rezai A. Surgical innovation and ethical dilemmas: a panel discussion. Cleve Clin J Med. 2008;75(Suppl 6):S13–21.CrossRefGoogle Scholar
  17. 17.
    Tan VK, Chow PK. An approach to the ethical evaluation of innovative surgical procedures. Ann Acad Med Singap. 2011;40(1):26–9.PubMedGoogle Scholar
  18. 18.
    Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral. The Belmont report: ethical principles and guidelines for the protection of human subjects of research, E. Department of Health, and Welfare, editor. U.S. Department of Health and Human Services; 1979.
  19. 19.
    Bernard HR, Hartman TW. Complications after laparoscopic cholecystectomy. Am J Surg. 1993;165(4):533–5.CrossRefGoogle Scholar
  20. 20.
    Frader JE, Caniano DA. Research and innovation in surgery. In: McCullough LD, Jones JW, Brody BA, editors. Surgical ethics. New York: Oxford University Press; 1998. p. 217–41.Google Scholar
  21. 21.
    Bracken-Roche D, Bell E, Karpowicz L, Racine E. Disclosure, consent, and the exercise of patient autonomy in surgical innovation: a systematic content analysis of the conceptual literature. Account Res. 2014;21(6):331–52.CrossRefGoogle Scholar
  22. 22.
  23. 23.
  24. 24.
    Strong VE, Forde KA, MacFadyen BV, Mellinger JD, Crookes PF, Sillin LF, Shadduck PP. Ethical considerations regarding the implementation of new technologie s and techniques in surgery. Surg Endosc. 2014;28(8):2272–6.CrossRefGoogle Scholar
  25. 25.
    Yang SH, Zhang YC, Yang KH, et al. An evidence-based medicine review of lymphadenectomy extent for gastric cancer. Am J Surg. 2009;197(2):246–51.CrossRefGoogle Scholar
  26. 26.
    Barkun JS, Aronson JK, Feldman LS, et al. Evaluation and stages of surgical innovations. Lancet. 2009;374(9695):1089–96.CrossRefGoogle Scholar
  27. 27.
    Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet. 2009;374(9695):1097–104.CrossRefGoogle Scholar
  28. 28.
    Orlowski L, Wateska JP. The effects of pharmaceutical firm enticements on physician prescribing patterns. There’s no such thing as a free lunch. Chest. 1992;102(1):270–3.CrossRefGoogle Scholar
  29. 29.
    Perry JE, Cox D, Cox AD. Trust and transparency: patient perceptions of physicians’ financial relationships with pharmaceutical companies. J Law Med Ethics. 2014;42(4):475–91.CrossRefGoogle Scholar
  30. 30.
    Altieri MS, Yang J, Wang L, Yin D, Talamini M, Pryor AD. Surgeons’ perceptions on industry relations: a survey of 822 surgeons. Surgery. 2017;162(1):164–73.CrossRefGoogle Scholar
  31. 31.
    Chaterji AK, Fabrizio KR, Mitchell W, Schulman KA. Physician-industry cooperation in the medical device industry. Health Aff (Millwood). 2008;27(6):1532–43.CrossRefGoogle Scholar
  32. 32.
    Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioeth. 2003;3:39–46.CrossRefGoogle Scholar
  33. 33.
    Lee Char SJ, Hills NK, Lo B, Kirkwood KS. Informed consent for innovative surgery: a survey of patients and surgeons. Surgery. 2013;153(4):473–80.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Division of Bariatric, Foregut and Advanced GI Surgery, Department of SurgeryStony Brook MedicineStony BrookUSA

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