LAW AND ETHICAL REASONING ON THE INFORMED CONSENT

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Article Title:	LAW AND ETHICAL REASONING ON THE INFORMED CONSENT
Authors:	SL Dr Teodor Dascal4, Prof Univ Dr Coralia Cotoraci1,2,3, SL Dr Camelia Stoian2, Asist univ drd Mircea Onel2,3, Asist univ drd Cristina Ghib-Para2,3, Asis univ drd Alciona Sasu1,2,3*
Affiliation:	1 Centre for Bioethics and Social studies, “Vasile Goldis” Western University of Arad, Romania 2 Faculty of Medicine, Pharmacy and Dentistry, “Vasile Goldis” Western University of Arad, Romania 3 Hematology Clinic, Emergency Clinical County Hospital of Arad, Romania 4 Faculty of Law, “Vasile Goldis” Western University of Arad, Romania
Abstract:	Ethics is the study of morality – careful and systematic reflection on the analysis of moral decisions and behavior, whether past, present and future (WMA, 2005). Ethics was closely linked to medicine since ancient times. Hippocrates was the exponent of an ethical medical act, the principle of beneficence being underlined in Hippocrates Oath. Nowadays, medicine changed dramatically, and thus the patient-doctor relationship changed also. Modern medical ethics is based on human rights. Medical ethics is also closely related to law. European laws related to human rights and patients’ rights are well known. But ethics and law are not identical. Quite often ethics prescribes higher standards of behavior that does the law, and occasionally ethics requires that physicians disobey laws that demand unethical behavior (Jones, 1931). Hippocrates said in his quotes: “Life is short, the Art long, opportunity fleeting, experience treacherous, judgment difficult. The physician must be ready, not only to do his duty himself, but also to secure the co-operation of the patient, of the attendants and of externals”. (Jones, 1931). What is the informed consent? According to the Medical Dictionary, the informed consent is the voluntary agreement to medical procedures/treatment given by a patient after the potential risks, hazards, and benefits of the treatment have been explained (Mosby, 2005). In the WMA Declaration on the Rights of the Patient it is written: “The patient has the right to self-determination, to make free decisions regarding himself/herself. The physician will inform the patient on the consequences of his/her decisions. A mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy. The patient has the right to the information necessary to make his/her decisions. The patient should understand clearly what is the purpose of any test or treatment, what the results would imply, and what would be the implications of withholding consent.” There are many national and international official documents that describe the informed consent, such as: Romanian Law No. 46/2003 on Patient rights, Romanian Law 95/2006 on Health Reform, completed with Order no. 1170/2014, Code of Medical Ethics of the College of Physicians in Romania, the European Convention on Human Rights and Biomedicine, Charter of Fundamental Rights of the European Union, European Parliament, Council and Commission, AMM (WMA) Declaration of Lisbon on the Rights of the Patient, 34th World Medical Assembly, Lisbon, Sept/Oct 1981, modified by the 47th WMA General Assembly, Bali, Indonesia, Sept 1995 and revised by the171st WMA Council Session, Santiago, Chile, Oct 2005, European Convention on Human Rights, Charter of Fundamental Rights of the European Union. Is it a legal demand or a moral one? The Romanian Law in force, in Chapter III, stipulates that any medical intervention needs the consent free and uncorrupted, obtained from the patient, previous to medical services, being an expression of freedom of any person. The patient has the right to refuse or to stop the medical intervention, thus assuming, in writing, the responsibility for his decision. Moreover, the patient has the legal right to medical information, on his own medical status, the right to health care of the highest quality (Law 95/2006, Law 46/2003). The procedure regarding the clinical decision-making within the Romanian hospitals includes special forms that the patient has to sign prior any medical/surgical intervention, after the correct information of the patient. Clinical Bioethics makes the clinicians to face many ethical dilemmas, every such case being different and raising multiple questions to solve.
Keywords:	informed consent; autonomy; decision-making; patient rights; beneficence
References:	1. Medical Ethics Manual, World Medical Association, ISBN 92-990028-0-0, 2005 2. Aphorisms, Hippocrates, trans. W. H. S. Jones (1931), Vol. 4, 99 3. Keidar, Daniella, Classroom communication. Use of emotional intelligence and non-verbal communication in ethics education at medical schools, the UNESCO Chair in Bioethics, The international Center for Health, Law and Ethics, Faculty of Law, University of Haifa, Israel, ISBN 965-7077-29-X, 2005 4. Jonas: Mosby’s Dictionary of Complementary and Alternative Medicine. (c) 2005, Elsevier. 5. http://www.dreptonline.ro/legislatie/legea_drepturilor_pacientului.php 6. http://www.scumc.ro/LegisDir/1.%20Legea%2095%20din%202006.pdf 7. Cotoraci Coralia, Onel Mircea, Sasu Alciona, ,,Bioethics – course for the students”, Arad, „Vasile Goldiş” University Press, 2013
*Correspondence: