Informed Consent and Informed Refusal: A Developing Country Perspective

  • Radmyla Yu. Hrevtsova
Reference work entry


The attitude of clinicians, from the countries with different cultures, legal systems and economic situation, to informed consent (and informed refusal) is not the same. Some of them take the duty to inform the patient and the consenting process seriously; others consider informed consent just as a mere formality. Proper understanding of the essence of informed consent and its attributes and peculiarities, depending on the type of medical care or research, is far more important for health-care professionals from developing countries where considerable attention to human rights in health care has started to emerge.

The issues arising in connection with the receipt and documentation of informed consent (informed refusal) are exemplified based on the legislation and practice of Ukraine. Fundamental elements of informed consent and the actions that need to be taken by the health-care professional to ensure their availability are discussed. Much attention is paid to the ways of expressing informed consent. The issues of withdrawal of informed consent and refusal from a medical intervention are also considered.

The inadmissibility of emasculating the idea of informed consent and transforming informed consent (informed refusal) into a legal fiction is pointed out. The improvements that need to be introduced in legislation and practice for ensuring that informed consent (informed refusal) performs its functions are also discussed.


Medical Intervention Grave Consequence Civil Code Legal Representative Criminal Liability 
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.


  1. 1.
    Ethics in research and international cooperation. European Commission. Research Directorate-General. Directorate L. Science, Economy and society. Unit L3. Governance and Ethics: Sept 2009;2009. Available at:
  2. 2.
    Amnesty International Annual Report 2012 – Ukraine; Available at:,AMNESTY,UKR,4fbe39045,0.html
  3. 3.
    Сердюк В. Роль общественности в обеспечении безопасности пациентов Украине [Serdiuk V. Role of the public in ensuring patients’ safety in Ukraine, Available at:].
  4. 4.
    Constitution of Ukraine. Adopted by the Supreme Rada of Ukraine on 28 June 2006.Google Scholar
  5. 5.
    Civil Code of Ukraine. Adopted by the Supreme Rada of Ukraine on 16 January 2003.Google Scholar
  6. 6.
    Law of Ukraine “Fundamentals of the legislation of Ukraine on health care” No. 2801-XII. Adopted by the Supreme Rada of Ukraine on 19 November 1992.Google Scholar
  7. 7.
    World Medical Association Declaration of Helsinki. Adopted by the 18th WMA General Assembly, Helsinki, Finland, 1964 Jun.Google Scholar
  8. 8.
    Procedure for the conduct of clinical trials of drugs and expertise of clinical trials materials. Approved by Order of the Ministry of Health of Ukraine No. 690 of 23.09.2009.Google Scholar
  9. 9.
    Rules for the conduct of clinical trials of medical equipment and medicinal products and Model Provisions on the Ethics Commission. Approved by the Order of the Ministry of Health of Ukraine No. 616 of 03.08.2012.Google Scholar
  10. 10.
    Сергеев Ю.Д [Sergeev YuD. Medical law: Textbook (in three volumes). Moscow: GEOTAR-Media;2008 p. 757].Google Scholar
  11. 11.
    Beauchamp TL, Childress JF. Principles of biomedical ethics. 4th ed. New York: Oxford University Press;1994.Google Scholar
  12. 12.
    Гревцова Р.Ю. Інформована згода на медичне втручання: юридичні аспекти отримання і оформлення////Управління закладом охорони здоров’я. – 2007. -№ 3. – С.12-17 [Hrevtsova RYu. Informed consent of a patient to medical intervention: legal aspects of receiving and documenting. The Health Care Institution Management. 2007;(3):12–7].Google Scholar
  13. 13.
    Law of Ukraine “On Consumers’ Protection” No. 1023-XII. Adopted by the Supreme Rada of the USSR on 12 May 1991.Google Scholar
  14. 14.
    Campbell B. Informed consent in developing countries: Myth of reality? Available at:
  15. 15.
    Миронова Г.А. Проблема визначення компетентності (медичної дієздатності) пацієнта як суб’єкта правовідносин з приводу медичного втручання//Часопис Академії адвокатури України. – 2012. – № 3. – С. 1–9 [Myronova G. The problem of competence of the patient as a subject of decisions in relation to medical interference. Courier of the Academy of Advocacy of Ukraine. 2012;(3):1–9].Google Scholar
  16. 16.
    Миронова Г.А. Медичний заповіт: новий інститут приватного права//Часопис Академії адвокатури України. – 2012. – № 1. – С. 1–10 [Myronova G. Living will: New institute of private law. Courier Acad Advocacy Ukraine. 2012;(1):1–10].Google Scholar
  17. 17.
    Order of the Ministry of Health of Ukraine “On approval of forms of primary medical documentation and instructions of their completion at health care institutions regardless of the form of property and organizational subordination” No. 110 of 14 February 2012.Google Scholar
  18. 18.
    Гревцова Р.Ю. Інформована згода пацієнта: правові аспекти//Ліки України. – 2007. - № 115–116. – С.76-78 [Hrevtsova RYu. Informed consent of the patient: Legal aspects. The Drugs of Ukraine. 2007;(115–116):76–8].Google Scholar
  19. 19.
    Instruction on the Procedure of artificial termination of pregnancy. Approved by Order of the Ministry of Health of Ukraine No. 508 of 20 July 2006.Google Scholar
  20. 20.
    Воробйова Н. Медико-правові аспекти отримання інформованої згоди на медичне втручання [Vorobyova N. Medico-legal aspects of receipt of informed consent for a medical intervention, Available at:].
  21. 21.
    Гревцова Р.Ю. Тенденції розвитку медичного і фармацевтичного права в Україні.//Другий Всеукраїнський конгрес з медичного права, біоетики і соціальної політики з міжнародною участю 14–15 квітня 2011 р., м. Київ: Збірник тез доповідей (Нуково-практичне видання)/Упор. к.ю.н. Гревцова Р.Ю., д.м.н. Степаненко А.В. – Київ: Видавництво «КІМ», 2011. – 132 с. – С. 31–32 [Hrevtsova RYu. The trends of development of medical and pharmaceutical law in Ukraine. The second all-Ukrainian congress on medical law, bioethics and social policy with international participation: Book of Abstracts: 31–31. Kyiv: KIM Publishing House; 2011].Google Scholar
  22. 22.
    Ethical Code of the Physician of Ukraine. Adopted and signed at the All-Ukrainian Congress of Physicians’ Associations and X Congress of the Ukrainian Doctors’ Association on 27 September 2009.Google Scholar

Further Reading

  1. Турак Й. А. Етичні та правові засади медичного втручання: З погляду лікаря практика. – Ужгород: ВАТ «Видавництво «Закарпаття», 2002. [Turak JA. Ethical and legal foundations of the medical intervention from the medical practitioner’s viewpoint. Uzhhorod: Zakarpattia Publishing House; 2002.]Google Scholar
  2. Пищита А. Н. Согласие на медицинское вмешательство. Медико-правовой анализ. Юридические стандарты. Практика реализации. М.: Центральная клиническая больница РАН, 2006 [Pishchita AN. Consent to medical intervention. Analysis from the standpoint of medical law. Legal standards. Practical Implementation. Moscow: Central clinical hospital of the Russian Academy of Science; 2006].Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Institute of Medical LawPharmaceutical Law and Bioethics at the Academy of Advocacy of UkraineKyivUkraine

Personalised recommendations