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Informed Consent in Graduate Education in Croatia

O Consentimento Informante em Cursos de Pós-Graduação na Croácia

Abstract:

Along with research on informed consent (since 1972), the need emerged to introduce this problem into bioethical education. Graduate education offers the possibility for scientific analysis of professional moral dilemmas with which physicians and related health care professionals are confronted when performing their professional activities. The issue especially relates to the patronizing relationship with patients, their traditional position, the realization of patients´ rights, duties of physicians and related health care professionals towards patients, and ethical matters in biomedical research. The answers to these issues, which contain the specification of informed consent, cannot be found exclusively in medicine and are a topic of social and human sciences. This article stresses the interdisciplinary approach towards researching informed consent, explains the relationship between informed consent and bioethics and philosophy, and presents the legal framework for informed consent in Croatia. The author then proceeds to define the problem of informed consent in the teaching curriculum and the simplification of objectives and tasks in learning about informed consent. Methods and examples of pedagogical and andragogical principles used to help comprise this program are offered, and methods used to achieve it are provided.

Key-words:
Bioethics; Education, Medical, Graduate; Curriculum

Resumo:

Ao lado da pesquisa sobre consentimento informado (desde 1972), surgiu a necessidade de introduzir esta questão no ensino da bioética. Os cursos de pós-graduação oferecem a possibilidade de uma análise científica dos dilemas morais enfrentados por profissionais de saúde, inclusive médicos, durante suas atividades profissionais. A questão diz respeito particularmente à eventual relação condescendente com pacientes, sua posição tradicional, o respeito pelos direitos dos pacientes, os deveres dos profissionais de saúde em relação aos pacientes e questões éticas na pesquisa biomédica. As respostas a essas questões, que incluem a especificação do consentimento informado, não se encontram exclusivamente no campo próprio da medicina, constituindo-se, assim, num tema para as ciências sociais e humanas. O artigo enfatiza a importância de uma abordagem interdisciplinar em relação à pesquisa sobre consentimento informado, ao mesmo tempo que explica a relação entre consentimento informado e bioética e filosofia e apresenta o marco jurídico para o consentimento informado na Croácia. O texto prossegue com uma definição do problema do consentimento informado no currículo de pós-graduação e a simplificação dos objetivos e tarefas no ensino desta questão. Finalmente, são oferecidos métodos e exemplos de princípios pedagógicos utilizados para ajudar a construir tal programa de ensino, junto com médicos para implementá-lo.

Palavras-chaves:
Bioética; Educação de Pós-Graduação em Medicina; Currículo

INTRODUCTION

Bioethical issues were introduced into graduate studies based on the need for universal insight into the significance of ethical analysis and decisions aimed at resolving bioethical problems with which physicians and related health care professionals in general are confronted while performing their professional activities. The contents and methods used in conducting an educational program at this level of study in the School of Medicine in Rijeka, Croatia, were conditioned by the fact that students enrolled in graduate studies had no previous exposure to various models of bioethical education. Therefore, the graduate studies curriculum was comprised of topics related to the history of medical ethics and bioethics, the basic theory and methods of ethical analysis, a range of problems linked to the term “bioethics” itself, and the normative, sociological, cultural, and religious contexts of biomedical ethics. The program enabled graduate students to obtain both information and an understanding of basic theoretical issues in medical ethics and bioethics and emphasized various ethical issues in modern medicine. The enrollment of graduate students who had acquired a basic theoretical understanding during their undergraduate training imposed changes on the curriculum. Lecturers in bioethics faced the challenge of finding areas which would embrace and enable a scientific analysis of professional moral issues with which graduate students are confronted in their medical/ethical activities. Professors had to search among a variety of topics which connect basic ethical knowledge to clinical practice to find a topic which would emphasize the analysis and evaluation of the following potential comprehensive medical and ethical issues: respect for patients' individuality, freedom of thought and decision-making, protection of patients’ rights in medical treatment and biomedical research, participation by family, guardians, or patients’ representatives in the ethical analysis and decision-making on the patients´ behalf, the relationship with children and patients with reduced decision-making capacity, consent by patients and examinees to treatment and research, and communications between health care professionals and patients. The area which encompasses all the above-mentioned issues is known to bioethics as informed consent.

Interdisciplinarity of Informed Consent

The interest demonstrated by social and human sciences in researching and analyzing informed consent has grown over the last two decades, due to the fact that it involves issues which do not pertain only to medicine itself. Bioethics has taken the leading role in analyzing the problem of informed consent with its different aspects. Philosophy plays a key role in the analysis and revision of traditional understanding and practice vis-à-vis humans and their relation to medical treatment and biomedical research. Immanuel Kant has an important place among philosophers whose thinking can foster a fundamental understanding of the relationship between health care professionals and patients. Thanks to the legal sciences, informed consent became a part of the legal norms which regulate patients' right to consent to or refuse diagnostic and therapeutic procedures. For a better understanding of the nature of informed consent in general, and especially in educating physicians and related health care professionals, the relationship between informed consent, bioethics, and philosophy should be more clearly explained, and the legal obligations of physicians and related health care professionals to inform and accept freely chosen decisions by patients and examinees should be identified.

Informed Consent and Bioethics

Informed consent is an area of modem medical activity that highlights the difference between medicine, medical ethics, and bioethics. In medicine, the term “medical ethics”, comprised of traditional ethical issues, is connected to the Hippocratic Oath. Medical ethics emerged as a syntagm in the19th century (Percival, Code of Medical Ethics, 1803). In addition to medical ethics proper, it includes the professional ethics of other health care professionals in hospitals and welfare institutions. The birth of bioethics (Potter, Bioethics: Bridge to the Future, 1971) was influenced by new and very complex ethical issues which appeared in the social and human sciences as a result of the application of modern techniques and technology in medicine. Bioethics differs from traditional medical ethics1 1 Together with issues of medical ethics, bioethics also involves moral issues related to ecology, population policies, animal protection, veterinary, social, and agricultural ethics, and ethical issues concerning food production. , which, according to the Hippocratic tradition, pertain exclusively to the physician. Bioethics includes other health care professionals who have contact with patients. The latter are considered individuals with the right to decide for themselves concerning their own health, to consent to or refuse medical treatment. Bioethics also includes the social and human sciences when solving problems in medical ethics, informed consent was born of these differences, as an American expression which is usually translated as “conscious”, “conscientious”, or “explicit consent”. The expression “conscious consent” appeared in the literature in 1957, and the problem began to be analyzed in 197211. Katz J. Informed consent: legal and ethical issues of consent in health care. New York: Encyclopedia of Bioethics, 1995. p. 1256.. Ruth Faden conducted research on informed consent in her medical dissertation, According to Faden, the definition of informed consent reads: “Informed consent is a statement given by the patient or examine with which he/she authorizes the physician or examiner to conduct the medical treatment or perform research”22. Segota I. Nova medicinska etika (bioetika). Rijeka: Medicinski fakultet, 1994. 91.. This definition emphasizes the change in the physician's patronizing role and the traditional patient's role. The main characteristic of this change is that the physician no longer makes decisions "about" or “for” patients, who cease to be unquestioning listeners and executors of the doctor’s orders. The physician is now “authorized” by patients, who become the protagonists of decision-making about their lives and health. The basic hypothesis for achieving these new roles is establishing a relationship in which patients are allowed to express whether they understand what the treatment expects of them, express their thoughts, fears, intentions, hopes, and satisfaction or dissatisfaction, and give or refuse consent to treatment and research. As follows from the definition, physicians and other health care professionals bear the responsibility for such a relationship. The definition also shows how it is possible to satisfy the demands of informed consent. The answer is patient/health care worker dialogue. In order to achieve results obtaining consent for treatment and research the dialogue should promote comprehension of patients' rights, ethical issues in biomedical research, ethical decisions, and methods for resolving ethically conflicting situations and cultural conditions in which the health care worker/patient relationship takes place. Since these are issues to which medical and health professionals cannot give exclusive answers when educating their students and as practice from countries with significant experience in bioethical education shows philosophers, ethicists, lawyers, theologians, sociologists, psychologists, and representatives of other sciences and professions dealing with the above-mentioned issues should be included in the educational process together with medical professionals. From their various scientific and professional perspectives, they can all contribute to an understanding of the above-mentioned problems and solutions. Interaction between these sciences and professions causes the relationship between health care professionals and patients and issues connected to informed consent to become social as well as medical. If we consider only one of these issues, that of health care professionals doing good for patients and examinees, then the issue contains the standpoint of what is good for patients, taking into consideration their values, their experience with good or bad treatment and research, viewpoints on the quality of their lives, their functional capabilities, and their religious and other beliefs as to what is correct. The revelation of such “components” of informed consent becomes recognizable in practice and ethical decision-making. Similarly, it becomes appreciated as a problem based on ethical, legal, philosophical, sociological, pedagogical, psychological, communicative, political, and other explanations, and not as a problem for the “natural talent” of the medical and related health care professions. The interdisciplinarity of interpretation, understanding, and seeking appropriate solutions - which can be applied in practice - introduced the problem of informed consent into the field of bioethics.

Informed Consent and Philosophy

Long before the birth of bioethics, philosophers33. Engelhardth D. Health and disease: history of the concepts. New York: Encyclopedia of Bioethics , 1995. p. 1083-1091. identified the need for changes in the traditional relations between patients and physicians and other health care professionals, in which patients are defined as objects and identified with both diseases and the data obtained through diagnostic procedures, and not as individuals with the right to decide about themselves and their health. They insisted on changing the treatment of patients through acceptance of their individuality and introduction of social, spiritual, ethical, and other human components for better comprehension of why diseases occur and of the process of healing and nursing. Immanuel Kant is most prominent among philosophers whose interpretation of ethics connects it to bioethics. Kant's thinking is current for bioethics in explaining the deontology theory, in the perception of the structure of moral conscience and nature of moral actions as well as the notion of autonomy. The problem of informed consent ascribes special importance to his idea of individuality, which is never omitted in interpreting the health care worker/patient relationship.

Since the Hippocratic age, the tradition al belief is that patients are unable to decide for their own benefit2 2 Secrecy of information, diverting attention from the disease, sometimes objecting, and at times comforting, are Hippocratic recommendations to physicians. The author of the book Code of Medical Ethics, Thomas Percival, following Hippocratic thought, advised physicians to inform patients only when absolutely necessary. Source: Katz, J. (1995), “Informed consent: Legal and Ethical Issues of Consent in Health Care”, Encyclopedia of Bioethics, New York, p. 1256. due to lack of familiarity with the medical profession and the secrets of medicine, and that the obligation towards patient well-being is sufficient to guarantee an ethical physician/patient relationship. Kant's notion of individually, which can be taken as the basis for the physician/patient relationship, stresses the need for questioning in order to make decisions for pati ents. Thus, Kant states: “Man is indeed rather unholy, but the huma nity in his character should be holy. Everything in the whole world man wants and has power over, he can also use only as an instru ment; he is only human, and with him every intelligent being has a purpose on its own”44. Kant, I. Kritika prakticnog uma, Zagreb, Kultura, 1956. p. 102.. Following this thought, Kant is even more specific in claiming that “no one (not even God) should use man as an instrument, and that he also be at the same time a purpose, therefore that humanity in our character should be holy”55. Ibidem, p. 152.. These thoughts tea ch us how to respect patients as individuals, express interest for patients, and respect their individuality. The opposite is indifference by physicians towards patients and their individuality, a cold and com manding approach, a repulsive position, a criticizing and negative evaluation of patients' positions and opinions. While Kant's approach to man emphasizes respect, emotional support, and care through a mutual relationship, the other approach follows a stereotype according to which physicians take complete control of decision-making for patients. The practical hypothesis of informed consent can be found in Kant's categorical imperative: “Perform so that the humanity in your character, and in the character of everyone else, is always taken also as a purpose, and never only as an instrument”66. Kant I. Osnove metafizike cudoredja, u: Dvije rasprave, Matica Hrvatska, 1953. p. 192.. Acting upon hat imperative means being able to tell the difference between good and evil, pain and comfort pleasure and displeasure, lies and truth, con ditions which are encountered in health care practice and are components of the bioethical analysis of informed consent. The reality of Kant's moral imperative cautions physicians and other health care professionals that their work should not be a routine and that they should always be interested and responsible researchers in the diagnostic process and medical treatment. Above all, because medical cases en tail concern for the lives of others, hope and trust that medicine and medical knowledge are doing everything possible for patients' well being, and fear of what has already happened and its possible consequences. In conditions where medical treatment and its course are defined only by medical knowledge, Kant's thoughts could be mentioned as a part of the historical relationship between medicine and philosophy Since contemporary medical treatment is under the influence of many non-medical factors representing a combination of medical, emotional, religious, philosophical, social, mutual, and indi vidual aspects, Kant's thinking is by all means current.

The Legal Framework for Informed Consent in Croatia

The duty to inform patients and their freedom to choose were promoted in the Croatian Health Care Actin the section titled "Rights and Duties of Citizens Performing Health Care”.77. Health Care Act, Zagreb, Narodne novine, br. 1/97. Under this Act, patients have the right to “accurate information on and instruction of all issues which concern their health”. They thus have the right to freely choose and consent to medical interventions3 3 In reference to the guidelines drawn up by the Ethics and Deontology Commission of the Croatian Medical Board and Croatian Medical Assembly, medical interventions are defined as intensive diagnostic and therapeutic procedures and surgery. offered to them by physicians or stomatologists, except in cases when failing to inter vene threatens the patient's life or leads to permanent damage. When patients are incapable of deciding on the medical intervention, family members, next of kin, or guardians make decisions on their behalf. Patients give written consent in cases when they refuse to participate in scientific research, surgical interventions, observation, examinations, and treatment by students as well for intervention performed solely by medical school graduates before they have passed their professional or stale board examination. The right to refuse a physical examination, treatment, or specific diagnostic or therapeutic procedu re also includes the right to change physician and stomatologist when patients undergoing medical intervention and treatment hove lost trust in the physician, or for any other reason which they are not obliged to disclose. The Croatian Ministry of Health has provided to all medical centers, hospitals, clinics, generalized and specialized hospitals, and health institutions a document for giving or refusing consent with reference to treatment and consent as confidential information within the medical documentation. This consequently regulates the legal basis on which patients have the right to know what is planned for them and have the right to consent or refuse Together with the patients' rights to ask questions, obtain information on diagnostic and thera peutic procedures, and give their consent, the legal basis for informed consent in Croatia also emphasizes physicians' commitment to in form patients on the entire medical treatment, possible risks of procedures and treatments, and available alternatives. The legally confirmed medical duties and the protection of patients’' rights when making decisions about their lives and health contribute to the approbation of patients' wishes as bearers of final decisions concerning their participation in medical interventions and biomedical research. Interpretation of the above-mentioned legal regulations establishes concrete duties for physicians and related health care professionals towards patients and ensures the protection of legally stated patient's rights. Such legal protection should thus be part of the educational program on informed consent.

Informed Consent in the Teaching Curriculum

The purpose and tasks of learning about informed consent

As in any other profession, education also achieves its meaning by defining its clear purpose and tasks. Specification of the purpose expresses what training institutions intend to achieve through the educational process, and the tasks describe how it becomes possible to achieve this purpose.88. Vukasovic A. Svrha i zadace odgoja i obrazovanja u: osnove suvremene pedagogije. Zagreb (HR): Hrvatski knjizevno-pedagoski zbor , 1999. p. 129-148. Therefore, the answer to the purpose of introducing informed consent into graduate education is that learning about informed consent allows for improvement in the quality of the relationship between health care professional and patients in the provision of health care, relations between medical research and examines in biomedical research, and the affirmation and achievement or freedom of rights for patients and examinees. Such a specified purpose can be achieved in two ways. The first involves a retinal, emotional, and willful activity field in the psychological lift of participants in education.99. Ibidem, p. 142-143. The rational field aims to introduce the role of informed consent into modern medical science and practice, explaining the reasons for changes in understanding information and consenting in contemporary medicine, as well as the consequence, which informed consent has on relations between health care professionals and patients, researchers and examinees; in addition, it explains the change in understanding the physicians traditional role as prime benefactor for patients. The emotional field cautions medical and related health care professionals and researchers that disease entails specific emotional conditions, that emotions affect the patients' decisions, and that empathy (optimism, caring, and the desire for recovery and cure) must thus be included in contact with patients. The willful activity field is recognized in the morally correct and ethically based behavior of physicians and related health care professionals in dealing with patients and examinees. Another method of focusing on the purpose of education is according to the “pedagogical tradition”1010. Ibidem. and defining material, functional, and educational tasks. In a concrete topical field, the material tasks refers to the definition of informed consent, the comprehension of its birth and historical development, recognition its importance in modern medical and health are activity, specification of its elements and functions, definition of the legal, philosophical, and theological theories which create its conceptual framework, and comprehension of the relationship between informed consent and primary and secondary bioethical principles, an interdisciplinary approach to its interpretation, and cultural aspects by which it is realized. By realizing the material task, one achieves the comprehension that each ethical decision in medicine and health care is composed of two equally important components. The first depicts the application of what is learned from medical science, and the second demands that the application of what is learned be morally correct and permitted. The functional task can be defined as the preparation of graduate students to evaluate their relationship with patients, to be capable of telling the difference between models of informed consent in practice, and the ethical analysis of their roles in creating these models. The educational task entails the sincere wish to help patients and examinees, an understanding of their problems, protection of their individuality, and avoidance of any patronizing attitude towards them. Each of these tasks can be further enhanced through more specific tasks: for example, reading literature on informed consent, stressing the altitudes of authors who have written on the subject, expressing thoughts towards these altitudes, seeking legal guidelines on issues of informed consent world wide and in Croatia, analyzing ethical norms on this matter in codes of ethics for medical and related health care professionals' associations. Defined and concretely proposed tasks play a multiple role: they can contribute to the change in the relationship between physicians and health care professionals and patients because they highlight the need to take patients' belief systems into consideration; they foster respect for patients' individuality and acceptance of their standpoints as to what is good and bad for them: they embrace the understanding of religious and other beliefs in patients’ lives and stress the comprehension of the influence of culture and civilization on the process of clinical judgment. The relationship between health care professionals and patients in realizing such defined tasks combines so-called “hard evidence”1111. Pellegrino DE, Siegler M, Singer AP. Teaching Clinical Ethics. J Clin Ethics 1990 fall; 1(3): 175-80. such as blood pressure, cholesterol levels, and positive tests for infection with so-called “soft evidence”, considering the patient a protagonist in decision-making on quality of life4 4 A touching story on quality of life and communication between physicians and the health care team and gravely ill patient was told by Jean-Dominique Bauby in his work Le scaphandre et le papillon. This work was translated in Croatia in 1997 through the Bioethics Library. , everyday activity, the joint definition by the health care worker as to the choice over accepting the proposed treatment or research procedure.

The Concept of the Educational Program

Issues related lo health, illness, life, and death are monitored by the public with special attention. Daily and weekly newspapers and radio and television create a space where one can read, char about, or watch the fate of diseased and handicapped persons, the success or failure of specific medical procedures, ethical or unethical conduct of health care professionals towards patients, the results of biomedical research, abuse of medical knowledge, use of new scientific and technological advances in medicine, the results of experiments performed on humans and animals, countries where specific diseases are being treated successfully, and safeguards for the rights of patients and examinees. Additionally, the mass media often have physicians and related health care professionals as guests who use lay language to answer questions from patients and others interested in a given disease or health condition. The information obtained further influences patients’ willingness to submit to investigation of their disease, to question the causes, and to seek methods for cure. Therefore, patients themselves, without former knowledge on informed consent, change their position towards medical treatment and biomedical research. The field of informed consent acknowledges this right to change, providing them more knowledge on the disease, its causes, duration, forms of treatment, possible sequelae, potential side affects of treatment, and research techniques. It is also a field in which the ethical principles and obligations of health care professionals towards patients and examinees are expressed and confronted. Based on the above, we can conclude that informed consent obliges participants in the diagnostic and therapeutic procedures and biomedical research lo foster an active relationship which takes patients' individuality into account and accepts their decisions.

Physicians themselves have requested help for continuing education and a program with topics to enable them to establish new relationships with patients. Results from some American clinics have confirmed this1212. Forrow L., Arnold R. Bioethics education: medicineNew York: Encyclopedia of Bioethics , 1995., showing that physicians feel insecure towards patients and express the demand for on adequate educational program for ethical problems in medicine. Supporting such a demand, some professional associations5 5 The American Committee for Internal Medicine 1983 and the American Pediatrics Committee in 1987, in their regular reports, announced references for teaching medical ethics to physicians. Source: Forrow, L., Arnold, R. Ibidem, p. 260. have recommended that the curriculum in ethics be composed such that health care professionals acquire comprehen sion and skills related to informed consent for treatment and research. Introducing this problem into graduate education enables the updating and judging of different situation in professional health care activities. Situations are those in which physicians and related health care professionals traditionally approach patients and seek information and on which they never comment or provide information, and those in which they provide reasonable explanations and instructions to patients. The first situations underscore the potential indifference of health care professionals to the patients' true conditions, creating in patients a feeling of insecurity and isolation. The latter type of situation encourages understanding of patients' wishes to receive information and data on themselves and their health conditions, where health care professionals actually acknowledge patients as protagonists in the medical/health treatment, thereby creating a feeling of security and respect. The question of quantity and comprehension of information provided to a severely ill patient gives a particularly important dimension to this problem. In severe cases, patients’ physici ans or families usually judge whether the patient is able to bear the information on their disease. The decision as to whether to speak with such patients about their disease is justified by the assessment that severe patients are emotionally and psychologically unable to accept the conditions entailed in their disease. The same reason is mentioned in relation to informed consent by psychiatric patients and children. All this contributes to the position according to which no element of informed consent, information, or consent act on their own, but are mutually connected. The basic connection is the chan ging role of patients and accepting patients as subjects who think, feel, and act as individuals capable of thinking for themselves. Informed consent is not only an instrument and technique for obtaining informa tion, but also a skill for building and developing relationships where information on conditions connected to health and disease are discove red, where diagnostic and therapeutic actions are taken, and where risks are possible in the application of advances in contemporary medi cine. This skill is acquired through education where physicians and related health care professionals analyze their relationship to patients, through forms of information exchange and evaluation which are suita ble for the planning and success of therapy, and by offering methods for creating a climate of trust between themselves and patients.

This education fosters an understanding of the importance of explaining and providing answers to patients´ questions on diagnostic procedures and planning of clinical and surgical interventions, about the experience of fear and dissatisfaction over the consequences of treatment, highlighting that rapid professional information and data do not prepare patients for consent. The process cautions that because of potential misunderstanding of medical vocabulary by patients and the “examiner” standpoint of physicians, patients remains passive and “examiners” are unable to obtain further potentially useful information to obtain consent for the proposed instructions and advice.

The above discussion leads us to the fact that a curriculum that helps educate phys1cians and related health care professionals on the problem of informed consent must emphasize the importance of changing the traditional relationship between health care professionals and patients. In accomplishing this task, the curriculum should emphasize both mutual actions by the medical and moral components in the relationship between health core professionals and patients and examinees and highlight that the decision regarding treatment and research applies not only “to” the patient but “with” the patient. This process can be implemented more successfully if it:

  • offers the results of research and studies on new methods for establishing relations between health care professionals and patients and relevant explanations of different communicati ons approaches in this relationship;

  • takes ethical, philosophical, legal, and other reasons into consideration to reduce the patronizing approach to patients and examinees and relates these reasons with actual patients in order for luck to accept or refuse medical interventions;

  • emphasizes the duty of health workers to inform patients and respects patients’ final decisions, while encouraging health care professionals to develop the decision-making capability of com petent patients;

  • explores the mutual action of judgmental components perta ining to health care professionals and patients, respectively;

  • reviews advances with informed consent in countries with a rich bioethical experience;

  • explains the medical, psychological, legal, ethical, and social elements, reasons, and borders in compulsive medical treatment;

  • identifies the importance of informed consent in each profes sion found in the gradual curriculum (board-certified physi cians, stomatologists, biochemists, pharmacists, pharmacologists, medical interns, and others); and

  • is integrated into the daily health care activities of graduate students.

Pedagogical and Andragogical Principles and Informed Consent

In order for the curriculum to connect theory to practical know ledge and participants' experience in the educational process, it must apply the corresponding pedagogical and andragogical principles. For the problem of informed consent, the following principles are important: activity and development, systematization and graduality, eco nomy, differentiability and dynamics1313. Matijevic M. Principi obrazovanja odraslih. u: Andrilovic V, Matijevic M, Pastuovic N, Pongrac S, Span M. Andragogija: Zagreb (HR), Skolska knjiga, 1985. p. 291-299., settling examples, and history and the modern age1414. Bognar L, Matijevic M. Didaktika. Zagreb (HR): Skolska knjiga, 1993. p. 130-131.. Activity and development is the exchange of cognition and experience among participants undergoing the educational process in solving a particular case and making an ethical decisi on. Systematization and gradualization is achieved by introducing into the curriculum those segments of informed consent which are closest to the health care professionals' professional experience. Each educational profile realizes the importance of informed consent in the res pective profession with the help of this principle: physicians. stomatologists, and life scientists working in their fields to obtain consent for medical treatment and research, medical engineers and biomedical researchers for the application of modern techniques and technologies, and pharmacists and pharmacologists for the application of drugs. The principle of economy informs lecturers that graduate students are employed, so that the entire curriculum must be adjusted to their living and work commitments. The source of differentiability and dynamics is the need to avoid the application of standardized methods and methods of presenting the curriculum. Setting examples emphasizes the constant modernization of the educational process and requires that the curriculum be supplemented every school year with new information and examples. Finally, the principle of history and the modern age requires that the problem of informed consent be historically “contextualized”, that the reasons for its absence from traditional medical ethics and the reasons for its emergence be explained, that its influence on contemporary ethical issues in medicine and health care be emphasized, and that the circumstances under which therapeutic interventions are possible without plaints’· consent be stated explicitly.

Informed Consent and Methods in Bioethical Education

Based on experience and references for methods of ethical education from countries with considerable experience in this area1515. Wachter MA. Medical ethics history of Europe New York, Encyclopedia of Bioethics, 1995., we believe that informed consent should be covered in graduate studies through lecture classes and in group study6 6 While most lectures of ethics and bioethics favor the idea that the number of students in a group should not exceed fifteen, the listed author stress the need to reduce that number and recommend working with groups of nine students, believing that this creates the basic guidelines for group work: greater communication among participants in the educational process, development of skills in ethical analysis, and consideration for various thoughts and ideas. 1616. Tysinger JW, Klonis L K, Sadler JZ, Wagner JM. Teaching ethics using small-group, problem based learning. J Med Ethics 1997 Oct; 23(5): 315-8.. Through lectures, gra duate students can learn about informed consent as an issue of medical ethics, the reasons for its development, the reasons why medical and related health care professionals act in harmony concerning the elements and functions of informed consent and differentiation be tween various “models of informed consent”7 7 For more on models of informed consent, see reference 17. 1717. Segota I. Informed consent Bioeticki svesci 1999; 20.. Study in small groups is an enhanced activity of graduate students based on learning from experience. The characteristics of this activity is group interaction and communication through which graduate students exchange experiences, connect theoretical understanding to practical activity, recognize appropriate and inappropriate patient treatment develop colla boration, and expand their sensitivity towards ethical problems in their profession.

The dynamics of activity in small groups contribute to methods in discussion, demonstration1818. Matijevic M. Principi obrazovanja odraslih. u: Andrilovic V, Matijevic M, Pastuovic N, Pongrac S, Span M. Andragogija: Zagreb (HR): Skolska knjiga , 1985. p. 273-289., and analysis of cases. Discussion methods are oriented towards understanding and sharing ideas, opinions, and perspectives among graduate students. The following types of discussion for the presentation of informed consent can be emphasized: “argumentation, free conversation, discussion, debate, table talk, and brainstorming”. The characteristics of argumentation, discussi on, and debate involving confronting viewpoints and argumentation among participants in the educational process, since individuals tend to adopt certain perspectives. Such types of discussion are suitable for informed consent, because they demand the ability to argument for and against a certain position. For example, concerning the problem of changing the traditional relationship with patients and exami nees, the “benefactor or autonomy model”, seeking consent for treatment and research, in fact use of drugs, application of informed consent to children and psychiatric patients, obtaining consent for “dependent categories” of examinees, signing consent forms, and refusing consent to medical interventions. The purpose of “table talk and brainstorming” is to allow graduate students' own standpoints and suggest possible ideas which help solve a specific case.

The demonstration method satisfies the need of students in the educational process to demonstrate the reality in which they take part. Thus, informed consent is a problem which can be successfully demonstrated to graduate students through “role-playing” and with the help of video and film material.

Case analyses methods enable graduate students to focus on a case related to informed consent from their own practice. By stating their case, graduate students are able to define why it relates to the field of informed consent, analyze elements of informed consent related to the case, offer methods for solving the case, explain basic reasons for reaching an ethical decision, and quote literature which helped them to acquire a theoretical background to help solve the case. “Elaboration” of a case from their own practice and discussions and analysis of medical and ethical aspects of “their” case with their colleagues enables the involvement of each graduate student, makes them aware that others also confront ethical problems, and engages them in considering an ethical approach as part of daily treatment procedures, biomedical research, and patient care. By acquiring knowledge through cases from their own practice, graduate students can see and prove that ethical thinking and conflicts are an integral component of medical practice, and confronting different ethical perspectives and values demonstrates and offers models for ethical conduct. Therefore, it can be said that graduate students themselves, by emphasizing and confronting their own ethical altitudes and offering solutions, contribute to the comprehension of informed consent.

Conclusion

The differences in respect to patients in traditional (Hippocratic) medical ethics and bioethics created informed consent. While in the former, patients are ignored and often underestimated as individuals, in the latter their individuality is appreciated and their right to consent to or refuse a proposed treatment or research protocol on the grounds of given information concerning the nature, risks, and consequences is respected. Informed consents a field of bioethics which expresses the richness, differentiability, and complexity of relations between health care professionals and patients, highlights the dignity of patients and examinees, stresses the right to decision-making auto nomy, and respects the decisions made. Informed consent contains answers to issues concerning moral decision-making and situations in which health care professionals and patients may have different values and beliefs. Informed consent also assists routine clinical activity in implementing ethical theories and moral principles. All these are reasons why the issues of healing, investigation, and care in graduate studies should seek a new understanding of medical, ethical, legal, religious, philosophical, and other components of informed consent. The information obtained thereby can help graduate students find new methods for mutual work with patients.

REFERENCES:

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    Engelhardth D. Health and disease: history of the concepts. New York: Encyclopedia of Bioethics , 1995. p. 1083-1091.
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    Kant, I. Kritika prakticnog uma, Zagreb, Kultura, 1956. p. 102.
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    Ibidem, p. 152.
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    Kant I. Osnove metafizike cudoredja, u: Dvije rasprave, Matica Hrvatska, 1953. p. 192.
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    Health Care Act, Zagreb, Narodne novine, br. 1/97.
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    Vukasovic A. Svrha i zadace odgoja i obrazovanja u: osnove suvremene pedagogije. Zagreb (HR): Hrvatski knjizevno-pedagoski zbor , 1999. p. 129-148.
  • 9
    Ibidem, p. 142-143.
  • 10
    Ibidem.
  • 11
    Pellegrino DE, Siegler M, Singer AP. Teaching Clinical Ethics. J Clin Ethics 1990 fall; 1(3): 175-80.
  • 12
    Forrow L., Arnold R. Bioethics education: medicineNew York: Encyclopedia of Bioethics , 1995.
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    Matijevic M. Principi obrazovanja odraslih. u: Andrilovic V, Matijevic M, Pastuovic N, Pongrac S, Span M. Andragogija: Zagreb (HR), Skolska knjiga, 1985. p. 291-299.
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    Bognar L, Matijevic M. Didaktika. Zagreb (HR): Skolska knjiga, 1993. p. 130-131.
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    Wachter MA. Medical ethics history of Europe New York, Encyclopedia of Bioethics, 1995.
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    Tysinger JW, Klonis L K, Sadler JZ, Wagner JM. Teaching ethics using small-group, problem based learning. J Med Ethics 1997 Oct; 23(5): 315-8.
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    Segota I. Informed consent Bioeticki svesci 1999; 20.
  • 18
    Matijevic M. Principi obrazovanja odraslih. u: Andrilovic V, Matijevic M, Pastuovic N, Pongrac S, Span M. Andragogija: Zagreb (HR): Skolska knjiga , 1985. p. 273-289.
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    Juric V. Metode razgovora u nastavi. Zagreb (HR) Pedagosko- knjizevni zbor; 1979. p. 62 i dalje.
  • 1
    Together with issues of medical ethics, bioethics also involves moral issues related to ecology, population policies, animal protection, veterinary, social, and agricultural ethics, and ethical issues concerning food production.
  • 2
    Secrecy of information, diverting attention from the disease, sometimes objecting, and at times comforting, are Hippocratic recommendations to physicians. The author of the book Code of Medical Ethics, Thomas Percival, following Hippocratic thought, advised physicians to inform patients only when absolutely necessary. Source: Katz, J. (1995), “Informed consent: Legal and Ethical Issues of Consent in Health Care”, Encyclopedia of Bioethics, New York, p. 1256.
  • 3
    In reference to the guidelines drawn up by the Ethics and Deontology Commission of the Croatian Medical Board and Croatian Medical Assembly, medical interventions are defined as intensive diagnostic and therapeutic procedures and surgery.
  • 4
    A touching story on quality of life and communication between physicians and the health care team and gravely ill patient was told by Jean-Dominique Bauby in his work Le scaphandre et le papillon. This work was translated in Croatia in 1997 through the Bioethics Library.
  • 5
    The American Committee for Internal Medicine 1983 and the American Pediatrics Committee in 1987, in their regular reports, announced references for teaching medical ethics to physicians. Source: Forrow, L., Arnold, R. Ibidem, p. 260.
  • 6
    While most lectures of ethics and bioethics favor the idea that the number of students in a group should not exceed fifteen, the listed author stress the need to reduce that number and recommend working with groups of nine students, believing that this creates the basic guidelines for group work: greater communication among participants in the educational process, development of skills in ethical analysis, and consideration for various thoughts and ideas.
  • 7
    For more on models of informed consent, see reference 1717. Segota I. Informed consent Bioeticki svesci 1999; 20..

Publication Dates

  • Publication in this collection
    25 June 2021
  • Date of issue
    Sep-Dec 2002

History

  • Received
    01 Mar 2002
  • Accepted
    18 Oct 2002
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