The Surgical Informed Consent Process: Myth or Reality?

  • Miguel A. CaínzosEmail author
  • Salustiano Gonzalez-Vinagre


Informed consent is currently considered to be a highly important factor which is becoming a critical component of surgical practice. It is a complex process and not just an event or a single encounter. In the twenty-first century, it is accepted that the traditional paternalist relationship between the patient and physician has been replaced by a new type of relationship in which the patient detents a very active and crucial role. For patients who need a surgical procedure, the informed consent process represents the honing of this link between the surgeon and his or her patient. The legal principle emphasizes the fact that the patient is an independent adult who has the capacity to authorize what is going to be done to his or her body. This is a process with significant ethical and legal aspects where both the surgeon and the patient play a major role.

The components which make up the informed consent process are the preconditions, the information provided to the patient, and the consent itself. The most complex step of the informed consent process for the surgeon is providing correct, truthful, unbiased, and accurate information to the patient while keeping hope in him or her. The physician disclosure has three stages: the disclosure of information, the patient understanding, and the patient decision-making. It is necessary to adapt the information to each patient in a language they can always understand. The physician must provide information about the surgical procedure, the benefits, the associated risks, potential complications, and alternative procedures, if any.

Surgeons must use all the available tools to adequately inform the patient and the relatives and improve his or her understanding: information leaflets, multimedia interventions, decision aids, the Internet, and government and professional organization guidelines. New tools as surgical risk calculators which estimate patient-specific postoperative complications for different procedures are now available.

The ultimate goal of the informed consent process should be fostering the patient’s trust in his or her surgeon.


Surgical informed consent Physician disclosure Trust Shared decision-making Tools for improving information 


  1. 1.
    Hanson M, Pitt D. Informed consent for surgery: risk discussion and documentation. Can J Surg. 2017;60:69–70.PubMedPubMedCentralGoogle Scholar
  2. 2.
    Wheeler R. The evolution of informed consent. BJS. 2017;104:1119–20.CrossRefGoogle Scholar
  3. 3.
    Grant SB, Modi PK, Singer EA. The surgical informed consent process. In: Ferreres AR, Angelos P, Singer EA, editors. Ethical issues in surgical care, vol. 2017. Chicago: American College of Surgeons Division of Education; 2017. p. 137–63.Google Scholar
  4. 4.
    Caínzos M, González-Vinagre S. Informed consent in surgery. World J Surg. 2014;38:1587–93.CrossRefGoogle Scholar
  5. 5.
    Canadian Medical Protective Association. Risk Fact Sheet CMPA. Available: Accessed 1 Mar 2016.
  6. 6.
    N.E. Schloendorff v. Society of New York Hospital 1914, 211 N.Y. 125 (106 N.E. 93) (N.Y. 1914).Google Scholar
  7. 7.
    Supreme Court of Minnesota. Mohr v Williams, 1905 (104 N.W. 12 Supreme Court of Minnesota).Google Scholar
  8. 8.
    WLR Bolam vs. Friern Hospital Management Committee, 1957 (1 WLR 583).Google Scholar
  9. 9.
    Salgo v. Leland Stanford Jr. University Board of Trustees, 1957 (317 P.2d 170).Google Scholar
  10. 10.
    F. Canterbury vs. Spence, 1972 (464 F.2d 772 (d.c. 1972)).Google Scholar
  11. 11.
    P. Truman v. Thomas, 1980 (611 P.2d 902 (Cal 1980).Google Scholar
  12. 12.
    Moore v. Regents of the University of California, 499 US 936 (1990).Google Scholar
  13. 13.
    Skene L, Smalwood R. Informed consent: lessons from Australia. BMJ. 2002;324(7328):39–41.CrossRefGoogle Scholar
  14. 14.
    Arato v. Avedon, 858 Pad 598 (Cal 1993).Google Scholar
  15. 15.
    Duttry v. Paterson, 771 A2d 1255 (Pa 2001).Google Scholar
  16. 16.
    Montgomery v Lanarkshire Health Board (Scotland), (2015); UKCS 11.Google Scholar
  17. 17.
    Ley 41/2002 de Noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica. Boletín Oficial del Estado, 15 de Noviembre de 2002. Págs. 40126–32.Google Scholar
  18. 18.
    Childers R, Lipsett PA, Pawlik TM. Informed consent and the surgeon. J Am Coll Surg. 2009;208:627–34.CrossRefGoogle Scholar
  19. 19.
    Weaver JP. A problem with informed consent. J Am Coll Surg. 2009;209:286–7.CrossRefGoogle Scholar
  20. 20.
    Acea B. Informed consent in the surgical patient. Reflections on the basic law of patient autonomy. Cir Esp. 2005;77:321–6.CrossRefGoogle Scholar
  21. 21.
    Leclercq WKG, Keulers BJ, Scheltinga MRM, et al. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg. 2010;34:1406–15.CrossRefGoogle Scholar
  22. 22.
    Char SJL, Lo B, Kirkwood KS. How important is disclosing surgeon experience when obtaining informed consent? J Am CollSurg. 2011;213(3S):S112–3.Google Scholar
  23. 23.
    Heneghan K, Walter KR. Legislative activities and informed consent. Bulletin American College of Surgeons. 2016;101:61–5.Google Scholar
  24. 24.
    Centers for Medicare & Medicaid Services. State Operations Manual. Appendix A – Survey protocol, regulations and interpretive guidelines for hospitals. Rev. 151. Nov 20, 2015. 482.51 (b). Accessed 5 July 2016.
  25. 25.
    The Joint Commission 2009 Requirements Related to the Provision of Culturally Care Hospital Accreditation Program (HAP). Hospital Accreditation Standards. Oakbrook Terrace, IL: The Joint Commission. 2009. Standard RI.01.03.01. Accessed 5 July 2016.
  26. 26.
    Skowron KB, Angelos P. Surgical informed consent revisited: time to revise the routine? World J Surg. 2017;41:1–4.CrossRefGoogle Scholar
  27. 27.
    Angelos P. The evolution of informed consent for surgery using the best case/worst case framework. JAMA Surg. 2017;152:538–9.CrossRefGoogle Scholar
  28. 28.
    Kruser JM, Nabozny MJ, Steffens NM, et al. “Best case/worst case”: qualitative evolution of a novel communication tool for difficult in-the-moment surgical decision. J Am Geriat Soc. 2015;63:1805–11.CrossRefGoogle Scholar
  29. 29.
    Taylor LJ, Nabozny MJ, Steffens NM, et al. A framework to improve surgeon communication in high-stakes surgical decisions: best case/worst case. JAMA Surg. 2017;152:531.CrossRefGoogle Scholar
  30. 30.
    Largerman A. Concurrent surgery and informed consent. JAMA Surg. 2016;151:601–2.CrossRefGoogle Scholar
  31. 31.
    Keulers BJ, Scheltinga MRM, Houtermann S, et al. Surgeons underestimated their patients’ desire for preoperative information. World J Surg. 2008;32:964–70.CrossRefGoogle Scholar
  32. 32.
    Rastogi P. Through the looking glass – understanding informed consent. Clinical Ethics. 2015;10:41–3.CrossRefGoogle Scholar
  33. 33.
    Scheer AS, O’Connor AM, Chan BPK, et al. The myth of informed consent in rectal cancer surgery: what do patients retain? Dis Colon Rectum. 2012;55:970–5.CrossRefGoogle Scholar
  34. 34.
    Solomon MJ, Pager CK, Keshava A, et al. What do patients want? Patient preferences and surrogate decision-making in the treatment of colorectal cancer. Dis Colon Rectum. 2003;46:1351–7.CrossRefGoogle Scholar
  35. 35.
    Masya LM, Young JM, Solomon MJ, et al. Preferences for outcomes of treatment for rectal cancer: patient and clinician utilities and their application in an interactive computer-based decision aid. Dis Colon Rectum. 2009;52:1994–2002.CrossRefGoogle Scholar
  36. 36.
    Fink AS, Prochazka AV, Herderson WG, et al. Predictor of comprehension during surgical informed consent. J Am Coll Surg. 2010;210:919–26.CrossRefGoogle Scholar
  37. 37.
    Ruíz Lopez R. Informed consent in surgery. Distance between theory and practice. Cir Esp. 2013;91:551–3.CrossRefGoogle Scholar
  38. 38.
    Braddock C 3rd, Hudal PL, Feldmann JJ, et al. Surgery is certainly one good option: quality and time-efficiency of informed decision-making in surgery. J Bone Joint Am. 2008;90:1830–8.CrossRefGoogle Scholar
  39. 39.
    Mulsow JJW, Feeley M, Tierney S. Review. Beyond consent – improving understanding in surgical patients. Am J Surg. 2012;203:112–20.CrossRefGoogle Scholar
  40. 40.
    Tamhankar AP, Mazari F, Everitt NJ, Ravi K. Use of the internet by patients undergoing elective hernia repair or cholecystectomy. Ann R Coll Surg Engl. 2009;91:460–3.CrossRefGoogle Scholar
  41. 41.
    Berland GK, Elliott MN, Morales LS, et al. Health information on the internet: accessibility, quality, and readability in English and Spanish. JAMA. 2001;285:2612–21.CrossRefGoogle Scholar
  42. 42.
    Murphy JO, Sweeney KL, O’Mahony JC, et al. Surgical informatics in internet: any improvement? Surgeon. 2003;1:177–9.CrossRefGoogle Scholar
  43. 43.
    Murphy MA, Joyce WP. Information for surgical patients: implications of the world wide web. Eur J Surg. 2001;167:728–33.CrossRefGoogle Scholar
  44. 44.
    Evans R, Elwyn G, Edwards A. Making interactive decision support for patients a reality. Inform Prim Care. 2004;12:109–13.PubMedGoogle Scholar
  45. 45.
    Department of Health. Good practice in consent implementation guide: consent to examination or treatment. London: Department of Health; 2001.Google Scholar
  46. 46.
    Atrey A, Leslie I, Carvell J, et al. Standardised consent forms on the website of the British Orthopaedic Association. J Bone Joint Surg Br. 2008;90:422–3.CrossRefGoogle Scholar
  47. 47.
    Fink AS, Prochazka AV, Henderson WG, et al. Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Ann Surg. 2010;252:27–36.CrossRefGoogle Scholar
  48. 48.
    American College of Surgeons. Public information from the American College of Surgeons, 2013.
  49. 49.
    Bilimoria KY, Liu Y, Paruch JL, et al. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013;217:833–42.CrossRefGoogle Scholar
  50. 50.
    Liu Y, Cohen ME, Hall BI, et al. Evaluation and enhancement of calibration in the American College of Surgeons NSQIP surgical risk calculator. J Am Coll Surg. 2016;223:231–9.CrossRefGoogle Scholar
  51. 51.
    Cohen ME, Liu Y, Ko CY, Hall BL. An examination of American College of Surgeons NSQIP surgical risk calculator accuracy. J Am Coll Surg. 2017;224:787–95.CrossRefGoogle Scholar
  52. 52.
    Kraemer K, Cohen ME, Liu Y, et al. Development and evaluation of the American College of Surgeons NSQIP pediatric surgical risk calculator. J Am Coll Surg. 2016;223:685–93.CrossRefGoogle Scholar
  53. 53.
    Lubitz AL, Chan E, Zarif D, et al. American College of Surgeons NSQIP risk calculator accuracy for emergent and elective colorectal operations. J Am Coll Surg. 2017;225:601–11.CrossRefGoogle Scholar
  54. 54.
    Kole J, Fiester A. Incidental findings and the need for a revised informed consent process. AJR. 2013;201:1–5.CrossRefGoogle Scholar
  55. 55.
    College of Physicians and Surgeons of Ontario. Consent to treatment. Dialogue. 2015;11:50.Google Scholar
  56. 56.
    Purcaru D, Preda A, Popa D, et al. Informed consent: how much awareness is there? PLOS ONE. 2014;9:1–6.CrossRefGoogle Scholar
  57. 57.
    Kim EK, Kim S. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level. Clin Trials. 2015;12:232–6.CrossRefGoogle Scholar
  58. 58.
    Halloch JL, Rios R, Handa RL. Patient satisfaction and informed consent for surgery. Am J Obstet Gynecol. 2017;217:181.e1–7.CrossRefGoogle Scholar
  59. 59.
    Grady C, Cummings SR, Rowbotham MC, et al. Informed consent. N Engl J Med. 2017;369:856–67.CrossRefGoogle Scholar
  60. 60.
    Goh HG, Shin SW. Informed consent. N Engl J Med. 2017;376:e41.CrossRefGoogle Scholar
  61. 61.
    Angelos P, Darosa DA, Bentram D, et al. Residents seeking informed consent: are they adequately knowledgeable? Curr Surg. 2002;59:115–8.CrossRefGoogle Scholar
  62. 62.
    McKneally MF, Martin DK, Ignani E, D’Cruz J. Responding the trust: surgeons’ perspective on informed consent. World J Surg. 2009;33:1341–7.CrossRefGoogle Scholar
  63. 63.
    Jamjoom AAB, White S, Walton SM, et al. Anaesthetists’ and surgeons’ attitudes towards informed consent in the UK: an observational study. BMC Med Ethics. 2010;11:1–7.CrossRefGoogle Scholar
  64. 64.
    The Association of Anaesthetists of Great Britain and Ireland Consent for anaesthesia. Revised ed. London: AAGBI; 2006.Google Scholar
  65. 65.
    Benjamin DM. Reducing medication errors and increasing patient safety: case studies in clinical pharmacology. J Clin Pharmacol. 2003;43:768–83.CrossRefGoogle Scholar
  66. 66.
    Baum N. Informed consent – more than a form. J Med Pract Manag. 2006;22:145–8.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Miguel A. Caínzos
    • 1
    Email author
  • Salustiano Gonzalez-Vinagre
    • 1
  1. 1.Department of SurgeryHospital Clínico UniversitarioSantiago de CompostelaSpain

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