REALIZATION OF INFORMED CONSENT AS ONE OF PATIENT RIGHTS: CURRENT SITUATION IN AZERBAIJAN

Abstract


Azerbaijan is a country in which the law is based on democratic principles. The mentioned principles are lying in the basis of the national healthcare law. Democratic values, such as respect for human rights and freedoms, human dignity, as well as universal bioethical principles that are widely implemented in national law, create conditions for implementation of patient's rights. The basic law governing the doctor - patient relationship - "Law on Protection of health of population in Azerbaijan” reflects the basic patients' rights and obligations of doctors and medical institutions. Informed consent, which is a key component of patient rights, is also reflected, however, to date, a significant drawback of the Azerbaijan medical legislation is described in the article in this field. For example, at the moment there is no single standardized informed consent form in the different country’s medical institutions. In the absence of such legally approved standards for informed consent form, public and private health care institutions provide such forms individually, which sometimes can differ significantly. At the moment, one of the important directions in the field of healthcare is its improvement in accordance with international standards. The authors also analyzed the main provisions of medical law of Azerbaijan and identified the main trends of its further development.

Full Text

The Republic of Azerbaijan is a unitary and democratic state. Laws in Azerbaijan Republic are based on state law. In Azerbaijan Republic acts and laws are made through a democratic process. Legal acts are voted on by the Parliament. So far, about 30 laws were adopted in the field of health in Azerbaijan. The most important of them is the Law on "Protection of Health of the Population" (1997). The Draft of the Law on Patient Rights presented to the Parliament, but has not been adopted yet. And, therefore, the rights of the patient are covered by Article 24 (Patient Rights) of the Law on "Protection of Health of the Population" for now. In this article the laws concerning patient rights, and the forms of informed consent in both public and private clinics in Azerbaijan will be reviewed. No human subjects will be involved in this study. The values of freedom, respect for human rights are essential elements of democracy. In turn, democracy provides the natural environment for the protection and effective realization of human rights. One of the important areas of human rights is the patient rights [4]. Each one may become a patient one day, so taking this into account everyone should have equal rights to health, to life and to be examined and treated without any kind of discrimination, including discriminations based on race, color, sex, language, religion, political or other opinion, national or social origin, property, birth or other status. These are the bases of democratic society. The human rights protection as main indicator of democratic process provides the means to examine systemic issues and state responsibility. Human rights principles that apply to patient care include both the right to the highest attainable standard of health, which covers both positive and negative guarantees in respect of health, as well as civil and political rights ranging from the patient’s right to be free from torture and inhumane treatment to liberty and security of person. They also focus attention on the right of socially vulnerable groups to be free from discrimination in the delivery of health care...[2] Historical events such as Nuremberg Trial, Tuskegee Syphilis Study, etc. disclose that the interference to the body of the patient without his/her consent is prohibited, and all states and individuals must comply with the principles of Bioethics and Universal Declaration of Human Rights. One of the main bioethical principles described in UNESCO Bioethics and Human Right Declaration of 2005 is Informed Consent. Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment [1].The term "informed consent" recognizes not only the patients' autonomy in decision but also the right to complete information. The informed consent process requires the physician to explain in sufficient detail, the diagnostic, therapeutic and prognostic reasoning that leads to his expert decision on what is in the best interest of the patient. Paternalism and coercion are antithetical to the concept of informed consent [5]. Basic or simple consent entails letting the patient know what you would like to do; giving basic information about the procedure; and ensuring that the patient assents or consents to the intervention. Assent refers to a patient’s willing acceptance of a treatment, intervention, or clinical care [6]. Informed consent is the permission or rejection of information presented in an open form and reflects the following: 25 1. The nature of the proposed medical procedure, results, risks, benefits and side effects, 2. Alternative medical procedures and their character, results, risks, benefits and side effects, 3. The risks and benefits, including potential harm to health or danger to life of the patient. As mentioned above the consent of patient must be voluntary. No one has the right to recruit persons by deception to participate in medical study or to make medical intervention to the body of patient without his/her consent. This is violation of human rights. The main role of informed consent is to protect patients to be treated in a wrong way and be informed about his/her health status. Informed consent is necessary for patients to participate more in their health, to get more information about it and take measures in a timely manner, and know own rights and may defend them. Philosophy of the respect of life and human dignity and the person’s rights to protection of health, in one way or another, is determining the legal system of Azerbaijan Republic. Article 41 of the Constitution of the Azerbaijan Republic protects “The Right for Protection of Health”. In this article stated that: 1. Everyone has the right for protection of his/her health and for medical care. 2. The state takes all necessary measures for development of all forms of health services based on various forms of property, guarantees sanitary - epidemiological safety, creates possibilities for various forms of medical insurance. 3. Officials concealing facts and cases dangerous for life and health of people will bear legal responsibility [3]. The philosophy of above mentioned principles is applicable and in a way reflected in other articles of the Constitution: Article 16 - The social development and state; Article 27 - The right for life; Article 37 - The right for rest; Article 38 - The right for social protection; Article 39 - The right to live in healthy environment, etc. [15] The principles of respect of life and human dignity and the person’s rights to protection of health [18] are also stated in other laws of Azerbaijan Republic. The main of them is Law of the Protection of Health of Population (June 26, 1997). The Article 24 of this Law is on Patient rights. In this article stated that patient has the rights as follows: • To choose a physician with his/her consent, treating doctor and treatment and prevention institutions, except cases of emergency medical assistance; • To be examined and treated in accordance with the requirements of sanitary - hygienic conditions; • To request inpatient council with the participation of experts from the medical institution and consultations; • To keep in a secret from surrenders the fact of applying for medical assistance, treatment, health status, the diagnosis of the disease, as well as other information obtained during the examination and treatment; • To give oral or written voluntary consent to medical intervention; • To refuse medical intervention; • To choose a person to obtain information about rights and responsibilities, and on health status and be able to give in terms of their interests this information; • To have a separate area to conduct religious ceremonies in the hospital subject to compliance with the rules [7]. If the rights of patient are violated he/she may apply to the head of treatment and prevention institution, relevant executive authority, or apply to the court in the manner prescribed by law. There are some significant legal acts regarding the rights of separate groups of patients: • Resolution of Cabinet of Ministers of Azerbaijan Republic on Rules of Medicinal Products Research, Research before clinic and clinical trials - 30.04.2010 [19] • Law on Psychiatric Care - June 12, 2001 [8] • Law on Drug Service and Control - June 29, 2001 [9] • Law on Transplantation of the Organs and/or Tissues of the Human - October 28, 1999 [10] • Law on State Care for Persons suffering from the Diabetes - December 23, 2003 [11] • Law on the Prevention of the Spread of Disease Caused by the Human Immunodeficiency Virus (AIDS) - April 16, 1996 [12] • Law on Private Medical Activity - December 30, 1999 [13] • Law on Blood and Its Components Donation - March 26, 1996 [14]. When we talk about patient rights of course we must pay special attention to the informed consent form. Every citizen has the right to obtain information acceptable to health information, including information on the survey results, the diagnosis and prognosis of the disease, treatment, and the degree of risk associated with this as well as on the results of treatment [2]. There is no single official form of informed consent and it is used in different forms in state and private hospitals of Azerbaijan. 26 Legislation of Azerbaijan Republic includes “The right of citizens to obtain information about the health status” - Article 25 of Law of the Health of Population (June 26, 1997). This Article is about informed consent and states that: “Every citizen has the right effectively to obtain information about his/her health status, including information of the outcome of the treatment, diagnosis and prognosis of the disease, treatment methods and the risks associated with it, and treatment results”. Information about the state of health of the citizens is given to his/her own, and information about the state of health of minors or persons who are considered to be disabled as defined by the law is given toheir parents or legal representatives by professionals who are directly involved to the examination and treatment. If the forecast of the disease is negative, information about this can be delivered to the patient's relatives or legal representatives, and in the careful form to the patient his/her own if he/she requires. Citizens are entitled to become familiar directly with medical documents reflecting the state of his/her health, and to get advice from other experts about them. At the request of the citizens copies of the medical records about the state of his/her health are provided [7]. The Article 26 and 27 of Law of the Health of Population (June 26, 1997) are about giving oral or written voluntary consent or refusing medical intervention. No one can be involved to participate in medical study or be forced to operation neither in public, nor in private hospitals in Azerbaijan. It is the violation of human rights and the persons who violate the rights of human (patients) are punished according to the applicable law [7]. National legislation on patients rights is applied both to public and private hospitals. So informed consent as one of patient rights concerns both medical treatment of the patient and medical research [16, 17] study on the patient in both public and private hospitals in Azerbaijan. In most cases, private and public hospitals in Azerbaijan Republic have their own forms of informed consent. These forms are often in written form. They respond to the main standards, they are understandable, simply written, but patients get so little information through these forms. Mostly, the written forms are used in severe surgeries to inform patient about the risks and benefits, and also to have evidence that the patient signed this form voluntary and gives permission to the intervention to his/her body. In both type of hospitals (public and private) the oral form of informed consent is used mostly for basic treatment or examination (measuring blood pressure, giving blood tests, ultrasound scanning, needle injections, etc.). As it was mentioned above each one may become a patient. Let’s consider the case study of one female patient of the public hospital who needed treatment of fractured hand bones after car accident. Doctors decided that surgery only way to recover. Patient was given informed consent form to sign (appendix No1). She wanted to know more about the risks and benefits of the operation but she was not given much information, doctors just tried to calm her down that everything will be in order. They told all about the risks to her parents. It was like in the past period of time, when doctors did not give any information to the persons directly, they gave information about health status or operations to the parents or closest people of the person. The informed consent form she was offered to sign was like just for preventing hospital and doctor rights rather than patient’s because not much information about diagnosis, alternative ways of treatment and other personalized details were given. In other private hospital where patient was applying for second opinion, she was re - examined by doctors who explained her everything in details what may be happened. They gave her all the information about her health and all potential risks under different alternative ways of actions. She was offered to sign the different form of informed consent (appendix No2). Patient was more satisfied by getting this information and took her own decision on surgery in this hospital. As seen from attached appendixes the forms are different. If the person does not wish to sign the informed consent form, nobody can force him/her to do that even in private hospitals. But, as seen from attachments, the form in private hospitals are more informative for the patient and represent the real personalized content of the individual case of the patient. The form used in public hospital looks like document just to prevent the doctor and institution from possible future complaints in case of negative outcomes of the treatment. Analysis of informed consent forms in other 20 public and 20 private hospitals revealed that informed consent forms are different. Forms in the private hospitals were more responding to the needs of the patients rather than in public. Taking mentioned above in account we propose suggestions to the Law on Patient Rights that is 27 under second reading now in national parliament to work out unified single form of informed consent for public and private hospitals that will reflect more detailed information about individual cases of patients containing diagnosis, proposed and alternative ways of treatment with possible complications. We consider it will protect the rights and responsibilities of patients and the rights and responsibilities of physicians in a better way than now. The study reflects current situation with formalization procedures of informed consent as one of main of patient rights and differences in forms of informed consent for public and private hospitals. In conclusion, the informed consent form is used in both type of hospitals in most situations for the surgeries with more than minimal risks. These forms help patients to be protected from wrong treatment and operations, and help physicians to prove that patient signed this form and is informed about all the risks and benefits of medical intervention to his/her body. None of medical institutions - neither public, nor private, may attract persons to surgeries, or treatment and examinations by financial or other ways and none of medical institutions may push persons to sign the informed consent forms. Appropriate laws and governmental organs will punish persons, who make such violations. We consider this is worth also to add in the form. Adoption of the Law on Patient Rights will play an important role in the protection of human rights in the health field of the country. Naturally, nothing ends with the adoption of the law, the exact opposite, it is the beginning, because the work on implementation of the Law should be developed, and there should be control and monitoring mechanisms, and there must be educational works about the Law among the population. The goal of this presentation to emphasize the objectives of research ethics training by a Fogarty International Center/NIH, funded program, in collaboration with CIS counties, particularly Azerbaijan

About the authors

F. A Rustamova

National Academy of Sciences of Azerbaijan fidan

Email: fidan.rustamova@gmail.com

PhD student, Azerbaijan unit, UNESCO Chair of Bioethics

V. G Mammadov

Baku State University

Email: vumammadov@yahoo.com

MD, JD, Professor of Forensic Medicine, Law Faculty the Azerbaijan unit, UNESCO Chair of Bioethics

K. M Munir

Harvard Medical School

Email: Kerim.Munir@childrens.harvard.edu

M.D., MPH, D.Sc., Professor

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