Skip to main content
SpringerLink
Log in

What a signature adds to the consent process

  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

Abstract

Background

“Consent is a process by which a patient is informed and becomes a participant in decisions regarding their medical management.” It is argued, however, that providing a signature to a form adds little to the quality of this process.

Methods

Views regarding the consent ritual of nonselected patients undergoing endoscopy (cystoscopy or sigmoidoscopy) were prospectively studied together with those of the attending staff. Patient volunteers were randomly assigned to one of two groups and given verbal explanation before the procedure, either alone (group A) or with a request to sign a form in addition (group B). A standardized questionnaire regarding preferences then was applied.

Results

A total of 37 patients (22 men) were studied along with seven staff members. Most surveyed felt that signing a consent form helped to empower the patient (group A, 84%; group B, 83%; staff, 100%). Although the patients mainly believed that it functioned primarily to protect the hospital and doctor (group A, 89%; group B, 67%), only one patient (3% of total) felt that such a formality undermined the patient–doctor relationship. Most staff members favored signing a form (86%). The majority of patients either favored it (group A, 47%; group B, 78%) or expressed no strong preference (group A, 32%; group B, 11%). Interestingly, more women than men preferred signing (73 vs. 55%; p = 0.25), perhaps because more women believed that it functioned to preserve autonomy (93 vs. 77% of men). Age was no particular determinant of perspective.

Conclusion

Although it may be viewed as primarily serving to protect the doctor and hospital, the formal process of signing written consent forms appeals to patients and staff.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Definition supplied via the Web site of the Royal College of Surgeons in Ireland. Retrieved 15 July 2007 at http://www.rcsi.ie

  2. Denis B, Bottlaender J, Goineau J, Peter A, Weiss AM (2002) Informed consent for gastrointestinal endoscopy: a patient opinion survey. Gastroentérol Clin Biol 26:675–679

    PubMed  Google Scholar 

  3. Worthington R (2002) Clinical issues on consent: some philosophical concerns. J Med Ethics 28:377–380

    Article  PubMed  CAS  Google Scholar 

  4. Habiba M, Jackson C, Akkad A, Kenyon S, Dixon-Woods M (2004) Women’s accounts of consenting to surgery: is consent a quality problem? Qual Saf Health Care 13:422–427

    Article  PubMed  CAS  Google Scholar 

  5. Sargos P, Pellerin D, Glorion B (1998) Patient education by the surgeon: judicial aspects, ethical aspects, deontological aspects. Chirurgie 123:85–95

    Article  PubMed  CAS  Google Scholar 

  6. Rouge-Maillart C, Tuech JJ, Pessaux P, Riche P, Penneau M (2001) Patient information management in the beginning of the 21st century. Presse Med 30:68–72

    PubMed  CAS  Google Scholar 

  7. Kirsch M (2000) The myth of informed consent. Am J Gastroenterol 95:588–589

    Article  PubMed  CAS  Google Scholar 

  8. Roque I, Hochain P, Merle V, Lerebours E, Hecketseiler P, Ducrotte P (2003) Assessment of the quality and psychological impact of information delivered using official consent forms in digestive endoscopy. Gastroenterol Clin Biol 27:17–21

    PubMed  Google Scholar 

  9. Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M (2004) Informed consent for elective and emergency surgery: questionnaire study. Brit J Obstet Gynaec 111:1133–1138

    Google Scholar 

  10. Agård A, Hermerén G, Herlitz J (2001) Patients’ experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient’s capacity? Heart 86:632–637

    Article  PubMed  Google Scholar 

  11. Williams BF, French JK, White HD, HERO-2 Consent Substudy Investigators (2003) Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study. Lancet 361:918–922

    Article  PubMed  Google Scholar 

  12. Agård A, Herlitz J, Hermerén G (2004) Obtaining informed consent from patients in the early phase of acute myocardial infarction: physicians’ experiences and attitudes. Heart 90:208–210

    Article  PubMed  Google Scholar 

  13. Terry PB (2007) Informed consent in clinical medicine. Chest 131:563–568

    Article  PubMed  Google Scholar 

  14. Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M (2006) Patients’ perceptions of written consent: questionnaire study. BMJ 333:528

    Article  PubMed  Google Scholar 

  15. Carter CA, Ruhe MC, Weyer S, Litaker D, Fry RE, Stange KC (2007) An appreciative inquiry approach to practice improvement and transformative change in health care settings. Qual Manag Health Care 16:194–204

    PubMed  Google Scholar 

  16. Triantafyllou K, Stanciu C, Kruse A, Malfertheiner P, Axon A, Ladas SD (2002) European Society of Gastrointestinal Endoscopy. Informed consent for gastrointestinal endoscopy: a 2002 ESGE survey. Dig Dis 20:280–283

    Article  PubMed  CAS  Google Scholar 

  17. Parmar VN, Mayberry JF (2005) An audit of informed consent in gastroscopy: investigation of a hospital’s informed consent procedure in endoscopy by assessing current practice. Eur J Gastroenterol Hepatol 17:721–724

    Article  PubMed  Google Scholar 

  18. Bassi A, Brown E, Kapoor N, Bodger K (2002) Dissatisfaction with consent for diagnostic gastrointestinal endoscopy. Dig Dis 20:275–279

    Article  PubMed  CAS  Google Scholar 

  19. Mills S, Law Society of Ireland (2005) Consent to medical treatment: medical law and litigation. Lecture 4, Blackhall Place, Dublin, Ireland

  20. Watkins EJ, Milligan LJ, O’Beirne HA (2001) Information and consent for anaesthesia: a postal survey of current practice in Great Britain. Anaesthesia 56:879–882

    Article  PubMed  CAS  Google Scholar 

  21. O’Dwyer HM, Lyon SM, Fotheringham T, Lee MJ (2003) Informed consent for interventional radiology procedures: a survey detailing current European practice. Cardiovasc Intervent Radiol 26:428–433

    Article  PubMed  CAS  Google Scholar 

  22. White SM, Baldwin TJ (2003) Consent for anaesthesia. Anaesthesia 58:760–774

    Article  PubMed  CAS  Google Scholar 

  23. Kerrigan DD, Thevasagayam RS, Woods TO, Mc Welch I, Thomas WE, Shorthouse AJ, Dennison AR (1993) Who’s afraid of informed consent? BMJ 306:298–300

    Article  PubMed  CAS  Google Scholar 

  24. Hoehner PJ (2003) Ethical aspects of informed consent in obstetric anesthesia: new challenges and solutions. J Clin Anesth 15:587–600

    Article  PubMed  Google Scholar 

  25. Burger I, Schill K, Goodman S (2007) Disclosure of individual surgeon’s performance rates during informed consent: ethical and epistemological considerations. Ann Surg 245:507–513

    Article  PubMed  Google Scholar 

  26. Williams CJ, Zwitter M (1994) Informed consent in European multicentre randomised clinical trials: are patients really informed? Eur J Cancer 30:907–910

    Article  Google Scholar 

  27. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC (2001) Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 358:1772–1777

    Article  PubMed  CAS  Google Scholar 

  28. Barata PC, Gucciardi E, Ahmad F, Stewart DE (2006) Cross-cultural perspectives on research participation and informed consent. Soc Sci Med 62:479–490

    Article  PubMed  Google Scholar 

  29. Molyneux CS, Peshu N, Marsh K (2005) Trust and informed consent: insights from community members on the Kenyan coast. Soc Sci Med 61:1463–1473

    Article  PubMed  CAS  Google Scholar 

  30. Allmark P, Mason S (2006) Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process. J Med Ethics 32:439–443

    Article  PubMed  CAS  Google Scholar 

  31. Saleh GM, Patel JI, Sivaprasad S, Tsesmetzoglou E, Fietje N, Saleh NM (2007) Digital Voice Signature: the future of consent? Clin Experiment Ophthalmol 35:297

    Article  PubMed  Google Scholar 

  32. Benbassat J, Pilpel D, Tidhar M (1998) Patients’ preferences for participation in clinical decision making: a review of published surveys. Behav Med 24:81–88

    Article  PubMed  CAS  Google Scholar 

  33. Levinson W, Kao A, Kuby A, Thisted RA (2005) Not all patients want to participate in decision making: a national study of public preferences. J Gen Intern Med 20:531–535

    Article  PubMed  Google Scholar 

  34. Berry MG, Unwin J, Ross GL, Peacock E, Juma A (2007) A comparison of the views of patients and medical staff in relation to the process of informed consent. Ann R Coll Surg Engl 89:368–367

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Surgery, Cork University Hospital, Cork, Ireland

    Peter Neary, Ronan A. Cahill, W. O. Kirwan & H. P. Redmond

  2. Department of Urology, Cork University Hospital, Cork, Ireland

    E. Kiely

Authors
  1. Peter Neary
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ronan A. Cahill
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. W. O. Kirwan
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. E. Kiely
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. H. P. Redmond
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to H. P. Redmond.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Neary, P., Cahill, R.A., Kirwan, W.O. et al. What a signature adds to the consent process. Surg Endosc 22, 2698–2704 (2008). https://doi.org/10.1007/s00464-008-9874-3

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00464-008-9874-3

Keywords

Search

Navigation