Comparative Law Researches

Comparative Law Researches

A Comparative Study of Criteria for Notifying the Patients about the Risks of Treatment in American, French, English and Iranian law

Document Type : Original Research

Authors
Omid Nasrollahi Shahri 1
Hojjat Mobayen 2
Mohammad Ali Khorsandian 3
omid asemani 4
1 PhD of Private Law, School of Law and Political Science of Shiraz University, Shiraz, Iran
2 Assistant Professor, Private and Islamic Law Department, School of Law and Political Science of Shiraz University, Shiraz, Iran
3 Associate Professor, Private and Islamic Law Department, School of Law and Political Science of Shiraz University, Shiraz, Iran
4 Assistant Professor, Medical Ethics Department, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Abstract
According to the governing principles of medical law, the doctor's intervention in the patient's treatment requires the informed consent of the patient. This consent is achieved when the patient has expressed her/his consent by having sufficient information about the treatment process and its risks. In this study, the question related to the issue that what risks the doctor should inform the patient is answered by a descriptive-analytical method and a comparative approach in American and French law. Despite the different approaches, the two main criteria of "importance of risk" and "probability of risk" are the most fundamental influencing factors in determining the scope of the doctor's commitment in informing about the risks of treatment. In French law, based on the types of risk, "serious" and "common" risks are recognized as the subject of the doctor's obligation to inform, but in American law, based on the approach founded on the patient's perspective and with objective criterion, the doctor is obliged to inform about the risks that are typically important and basic from the patient's point of view, according to the "severity of the risk" and the "percentage of its occurrence". The new approach of English law is also an integrated approach based on "active interaction between doctor and patient" which, due to attention to the specific characteristics and conditions of the patient under treatment, brings maximum efficiency to realize informed consent. The same approach is also suggested in Iran law, which means that before treatment, the doctor, by examining the patient's condition, mood and views, in an active interaction, recognize important risks from the patient's point of view, and in cases where access to the patient's point of view, it was not possible to use the criterion of the reasonable patient.
Keywords
Notification
Informed consent
Treatment risks

Subjects

1. Ajori Ayask, A.; Mohammad Hassani, S.; Razavi, S.A.; Vahdati Shobeiri S.H. (2021) “The Physician’s Duty to Warn Non-patients; Comparative Study in the Law of Iran and the United States of America”, Amoozeha-ye Feqh-e Madani, 13(23):3-38. [Persian].
2. Bert D. (2010) “The Light of Judgment Mercier!”, Rec Dalloz, 28(7433):1801-2. [French].
3. Ciortea A.E. (2017) “What Medical Risks Should Physicians Disclose to their Patients? Towards a Better Standard in American and French Medical Malpractice Law”, J Civ L Stud.,10:173-221.
4. Debarre J-M. (2017) “Consent to Medical Care in Law. An Overview”, Médecine & Droit, (144):57-69. [French].
5. Ghafourian, M.; Safaei, S.; Abbasi, M. (2018) “Analyzing Role of Patient Autonomy in Informed Consent”, Akhlagh-e Zisti, 8(29):43-51. [Persian].
6. Grzegorz Mazur, O.P (2012) Informed Consent, Proxy Consent, and Catholic Bioethics: For the Good of the Subject, 1st ed. Netherlands: Springer.
7. G'Sell-Macrez, F. (2011) “Medical Malpractice and Compensation in France: Part I: the French Rules of Medical Liability Since the Patients' Rights Law of March 4, 2002”, Chi-Kent L Rev, 86(3):1093-123.
8. Heywood, R.; MacAskill, A.; Williams, K. (2010) “Informed Consent in Hospital Practice: Health Professionals’ Perspectives and Legal Reflections”, Medical Law Review, 18(2):152-84.
9. Heywood, R. (2005) “Excessive Risk Disclosure: The Effects of the Law in Medical Practice”, Medical Law International, 7(2):93-112.
10. Hostiuc, S.; Buda, O. (2019) The Age of Informed Consent: A European History, 1st ed., England: Cambridge Scholars Publishing.
11. Joodaki, B.; Khaleghi, A. (2012) “Patient’s Consent, Legal Conditions and their Criminal Protection”, IJME., 5(6):14-26. [Persian]
12. Jourdain, P. (2010) “Failure to Comply with the Duty to Information Medical Causes Damage that Must be Repaired (Reversal of Jurisprudence)”, RTD Civ., 3(1):559-80. [French].
13. Katz, J. (2002) The Silent World of Doctor and Patient, 1st Revised ed., Maryland: Johns Hopkins University Press.
14. Le Goues, M. (2015) The Consent of Patient in Health Law, Avignon: Avignon University. [French].
15. Lotfi, E. (2009) “From Informed Consent to Knowingly Choosing: A Study on the Commitment to Information Delivery in Physician-Patient Relationship”, Hoghoogh-e Pezeshki, 3(11):39-73. [Persian].
16. NasrollahiShahri, O.; Mobayen, H. (2020) “Basics of the Physician's Duty of Notification to Patient about the Risks of Treatment”, Akhlagh-e Pezeshki, 14(45):1-15. [Persian].
17. Nematollahi, M.; Sakhdari, A. (2015) “Amount of Obtained Informed Consent from the Hospitalized Patient to Selected Hospitals in Shiraz City”, Modiriyat-e Ettela’at-e Salamt, 11(6):689-98. [Persian].
18. Parsapoor, M.B.; Ghasemzadeh, S.R. (2011) “Legal and Jurisprudential Study of Patient’s Informed Consent and Physician’s Duty of Notification: A Comparison between Iranian, English and French Law”, IJME, 5(1):39-50. [Persian].
19. Piper Jr., A. (1994) “Truce on the Battlefield: A Proposal for a Different Approach to Medical Informed Consent”, The Journal of Law, Medicine & Ethics, 22(4):301-313.
20. Porcher, R. (2019) “Consent and Medical Law”, Médecine & Droit, 1(154):8-19. [French].
21. Sargos, P. (2010) “Two “Historic” Judgments in Terms of General Medical Liability and Specific Liability Linked to a Doctor's Failure of his Duty to Inform”, Rec Dalloz, 24(7429):1522-6. [French].
22. Shah, P.; Thornton, I.; Turrin, D. (2020) Hipskind JE. Informed Consent, Florida: StatPearls Publishing, Treasure Island (FL).
23. Shandell, R.E.; Schulman, F.A.; Smith, P. (2018) The Preparation and Trial of Medical Malpractice Cases, 1st Revised ed., New York: Law Journal Press.
24. Sheikh Taheri, A.; Farzandipour, M. (2008) “Quality of Informed Consent Process in Inpatients Undergoing Surgery”, Pezeshki-ye Ghanooni-ye Iran, 14(3):151-8. [Persian].
25. Taghaddosinejad, F.; Akhlaghi, M.; Yaghmaei, A.; Hojjati, A. (2008) “A Survey of Obtaining Informed Consent and Acquit from Admitted Patients in Emam Khomeini Hospital”, Pezeshki-ye Ghanooni-ye Iran, 14(1):12-7. [Persian].
26. Taylor, S. (2012) “Cross-border Patients and Informed Choices on Treatment in English and French Law and the Patients’ Rights Directive”, European Journal of Health Law, 19(5):467-84.
27. Terrion, H. (1993) “Informed Choice: Physicians’ Duty Disclose Nonreadily Available Alternative”, Case Western Reserve Law Review,43(2):491-523.
28. Thouvenin, D. (2001) “Scope of a Reversal of Case-Law Concerning the Physician's Duty to Inform”, Rec Dalloz, 43(1):3470-7. [French].
29. Vansweevelt, T.; Glover-Thomas, N. (2020) Informed Consent and Health: A Global Analysis, 1st ed., England: Edward Elgar Publishing.
30. Vialla, F. (2013) “Nature of the Liability and Damage Repairable in Case of Failure in the Delivery of Health Information”, Médecine & Droit, 1(120):57-64. [French].