Informed Consent

  • Michèle Stanton-JeanEmail author
  • Hubert Doucet
  • Thérèse Leroux
Reference work entry


The doctrine of informed consent is now recognized worldwide through several international guidelines and normative instruments. Based on respect for the dignity and autonomy of patients and research participants, it has been the subject of numerous publications for quite some time. In a globalized world where a variety of spiritualities and cultures are in close contact, the subject is discussed at length with respect to how it can be applied in all contexts, particularly in the context resulting from recent scientific and technological developments, especially in genetics and genomics. More specifically, the meaning and scope of the word “informed” is questioned more and more depending on the individual, group, or country to which it applies. This chapter examines the various challenges raised in the literature related to the use of this concept in a globalized world. It postulates that the answers to questions are not definitive, and that each possible solution must be based on the dialogue between all involved and on the respect and autonomy of the individual, even if the decision-making process may vary depending on the context in which research and medicine are practiced.


Health Literacy Bacterial Meningitis Adequate Information Scientific Development Advance Care Planning 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The Canadian Commission for UNESCO generously contributed to the translation of this chapter.


  1. Agich, G. J. (1998). Human experimentation and clinical consent. In J. F. Monagle (Ed.), Health care ethics: Critical issues for the 21st century. Gaithersburg, MD: Aspen.Google Scholar
  2. Andorno, R. (2004). The right not to know: An autonomy based approach. Journal of Medical Ethics, 30, 435–440.CrossRefGoogle Scholar
  3. Benatar, S. R. (2002). Reflection and recommendations on research ethics in developing countries. Social Science & Medicine, 54, 1131–1141.CrossRefGoogle Scholar
  4. Canadian Medical Protective Association. (2006). Consent: A guide for canadian physicians. Retrieved August 2012, from
  5. Caulfield, T. R., Upshur, E. G., & Daar, A. (2003). DNA databanks and consent: A suggested policy option involving an authorization model. BMC Medical Ethics, 4, 1.CrossRefGoogle Scholar
  6. Chadwich, R. (1997). The philosophy of the right to know and the right not to know. In M. L. Chadwich, M. L. Chadwich, & D. Shickle (Eds.), The right to know and the right not to know. Aldershot/Brookfield, VT: Avebury.Google Scholar
  7. Collège des médecins du Québec. (2007). Guide de pratique en soins de longue durée. Retrieved April 2012, from
  8. Fan, R., & Tao, J. (2004). Consent to medical treatments: The complex interplay of patients, families and physicians. The Journal of Medicine and Philosophy, 29(2), 139–148.CrossRefGoogle Scholar
  9. Health Canada. (2008). Implementation Guide to Advance Care Planning in Canada: A Case Study of Two Health Authorities. Retrieved April 2012, from
  10. Health Literacy in Canada. (2007). Initial results from the International Adult Literacy and Skills Survey, Ottawa.Google Scholar
  11. International Bioethics Committee. (2011). Report of IBC on the Principle of Respect for Human Vulnerability and Personal Integrity, Paris, SHS/EST/CIB-17/10/CONF.501/2 Rev 2Google Scholar
  12. Jefford, M., & Moore, R. (2008). Improvement of informed consent and the quality consent documents. The Lancet Oncology, 9(5), 485–493. Retrieved April 2012, from Scholar
  13. Katz, J. (1984). The Silent world of Doctor and Physician. New York: The Free Press.Google Scholar
  14. Kegly, J. A. K. (2004). Challenges to informed consent. EMBO Reports, 5(9), 832–836.CrossRefGoogle Scholar
  15. Khabir, A. (2001). A Drug Company sued over research trial in Nigeria. Lancet, 358(9284), 815.CrossRefGoogle Scholar
  16. Knoppers, B. M., & Chadwick, R. (2006). Human genetic research: Emerging trends in ethics. Focus, The Journal of Lifelong Learning in Psychiatry, IV(3), 416–422.Google Scholar
  17. Luther, L., & Lemmens, T. (2012). Human genetic data banks: From consent to commercialization- an overview of current concerns and conundrums. Biotechnology, XII, 183–217.Google Scholar
  18. Marshall, P. A. (2007). Ethical challenges in study design and informed consent for health research in resource-poor settings. In Special Topics in Social, Economic and Behavioural (SEB) (Research report series; No. 5). Geneva: WHO.Google Scholar
  19. Molyneux, C. S., et al. (2005). Even if they ask you to stand by a tree all day, you will have to do it (laughter)…! Community voices on the notion and practice of informed consent for biomedical research in developing countries. Social Science & Medicine, 61, 443–454.CrossRefGoogle Scholar
  20. NHMRC. (2011). Guidance for the National Approach to Single Ethical Review. Australia: NHMRC. Retrieved August 2012, from
  21. Salgo v. Leland Stanford Jr. University Board of Trustees, (1957). 317P. 2d 170 (Cal Dist. Ct. App 1957, Retrieved April 2012, from
  22. Schachter, M., & Fins, J. J. (2008). Informed consent revisited: A doctrine in the service of cancer care. The Oncologist, 13(10), 1109–1113. Retrieved August 2012, from Scholar
  23. TCPC. (2010). Canadian Institute of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. In Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). Retrieved November 2012, from
  24. UNESCO. (2005). Universal Declaration on Bioethics and Human Rights, Paris.Google Scholar
  25. UNESCO. (2009). Report of the International Bioethics Committee of UNESCO (IBC on Consent). Paris.Google Scholar
  26. Wahl, J. (2006). Advance Care Planning – The Legal Issues, October 2006. Retrieved April 2012, from
  27. Wiwchar, D. (2004). Nuu-chah-nulth blood returns to west coast. Ha-Shilth-Sa, 31(25), 1–4.Google Scholar
  28. World Medical Association. (2008). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. In 59th WMA General Assembly, Seoul, October 2008. Retrieved August 2012, from
  29. Zawati, M. H., Van Ness, B., & Knoppers, B. M. (2011). Incidental findings in genomic research: A review of international norms. GEN, 9(1), 1–8. Retrieved August 2012, from

Copyright information

© Springer Science+Business Media Dordrecht 2014

Authors and Affiliations

  • Michèle Stanton-Jean
    • 1
    Email author
  • Hubert Doucet
    • 2
  • Thérèse Leroux
    • 3
  1. 1.Centre de Recherche en Droit PublicUniversité de MontréalMontrealCanada
  2. 2.Faculty of Theology and Religious StudiesUniversité de MontréaMontrealCanada
  3. 3.Centre for Research in Public LawUniversité de MontréalMontrealCanada

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