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2 Pharm Med 2008; 22 (5): FOCUS ON EASTERN EUROPE AND CENTRAL ASIA /08/ /$48.00/ Adis Data Information BV. All rights reserved. Developing National Systems for Research Ethics Education in Eastern Europe and Central Asia Mykola Chaschin, 1 Tatyana Mishatkina, 2,3 Marina Guryleva, 4 Svetlana Pustovit, 5,6 Feruza Zagirtdinova 7 Bakhyt Sarymsakova 8 and 1 National Scientific Center for Medical and Biotechnical Research, National Academy of Science, Kiev, Ukraine 2 National Bioethics Committee of the Republic of Belarus, Minsk, Belarus 3 International State Sakharov Environmental University, Minsk, Belarus 4 Department of Medical Ethics and Law, Kazan State Medical University, Kazan, Tatarstan, Russian Federation 5 National Medical Academy of Post-Graduate Education, Kiev, Ukraine 6 National Association on Bioethics, This Kiev, Ukraine material is 7 Tashkent Medical Academy, National University of Uzbekistan, Tashkent, Uzbekistan 8 National Scientific Maternity and Childhood Centre, Astana, Kazakhstan Abstract This article aims to provide a short overview of research ethics education in Azerbaijan, Armenia, Belarus, covers the cooperation between these countries in the field of bioethical education and the impact of the Bologna original Process on national systems for research publisher. ethics education. Special attention given to the issues of teaching bioethics in graduate and postgraduate programmes and the training of ethics committee members. Georgia, Kazakhstan, Kyrgyzstan, Moldova, the Russian Federation, Tajikistan, Uzbekistan and Ukraine. It Universal ethical Unauthorised values aimed at protecting human rights and copying in the profound social and political changes taking place in the training; therefore all medical schools should have a department of medical ethics, along with an appropriate number of trained ex- perts. dignity are playing an increasing role in the development of biology and medicine in the world today. This has been reflected post-soviet countries. A largely unique body of experience in the sphere of bioethics, and particularly in the field of developing national systems for research ethics education, has been accumu- Following the WHO recommendations, some higher education- al facilities in the CIS launched bioethics courses in philosophy, psychology, medical and other faculties. In addition, some bioethical issues were added into existing undergraduate and postgradu- ate training courses for medical professionals, biologists, social workers and veterinarians, and eventually specialized training modules and courses in bioethics were designed. lated by the Commonwealth of Independent States (CIS), which comprises Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, the Russian Federation, Tajikistan, Uzbekistan and Ukraine. Education in bioethics at Azerbaijan Medical University began in 2000 with a teaching course in biomedical ethics that had an interdisciplinary character: issues of biomedical ethics were inte- grated into the curriculum of all departments, both clinical and In October 1994 the fourth World Health Organization (WHO) conference on issues surrounding medical ethics education was held in Geneva; this conference advocated that the coaching of ethics (bioethics) should be mandatory rather than optional. Participants at the conference agreed that medical ethics should become an integral part of medical education and that its coaching should be obligatory and continuous during the entire undergraduate educational process and continue throughout postgraduate 1. Ethics Programme Developments in the Commonwealth of Independent States 1.1 Azerbaijan

3 290 Chaschin et al. nonclinical. A team was set up at the Azerbaijan Medical Univer- Courses are directed at raising awareness of the modern principles sity to develop a programme to teach methodology and practical behind bioethics and biomedical ethics, the relevant legislation issues (the programme was called Introduction of Teaching Mater- and assisting in the development of skills for coping with various ials on Biomedical Ethics into the Syllabus of Higher Educational ethical problems that may arise during professional activity. Institutes) as well as other course materials, including the first During the course, students are introduced to issues related to Azerbaijan manual on medical ethics, the Tiabaiat etikasy. various ethical problems associated with the development of new technologies in healthcare. These concerns include: 1.2 Armenia the role of ethics and law in the provision of medical help; At the Yerevan State Medical University in Armenia, a course the personal rights of the patients; in bioethics was also introduced in the year A major stimu- informed consent, competency and decision-making capacity; lus for introducing bioethics into the syllabus was the essential specific groups of patients; need to harmonize local education programmes with international genetics; standards. However, bioethics remains an elective course at the university. The programme involves theoretical and practical studhuman the ethical and legal aspects of biomedical research involving ies including a number of different tests and questionnaires designed subjects. for students to examine their own moral and psychological 1.5 Kazakhstan ethics and medical law; readiness to observe the standards and requirements of modern discipline was not previously included in the State standard of biomedical ethics and law are included in the training programme bioethics; a number of plays and films are also available for subjective and evidence-based studies of themes such as the doctor-patient relationship, the use of language by doctors and forced hospitalization. 1.3 Belarus In Belarus, the year 2000 marked the issue of one of the first ethics-related textbooks in a CIS country; Biomedical Ethics [1] introduced students studying biology and medicine to bioethics. However, the search continues for an interdisciplinary approach to help bring the currently held moral and ethical norms into line with current international medical and biological reality. This work Similarly, the state standard of education in the Kyrgyz Repub- lic does not include bioethics as a separate subject, yet the teaching of bioethics is conducted at the diploma level at Kyrgyz State Medical Academy, where the curriculum includes the theme of ethical and legal control of biomedical research. In addition, courses on basic and clinical pharmacology provide information on clinical trials and the principles of good clinical practice (GCP) to students of all faculties. must include discussions on the humane treatment of laboratory animals in biomedical research. The implementation of alternative teaching aids (e.g. computer programmes of experiments on virtu- al animals, videos, CDs, 3-dimensional models, etc.) have allowed researchers to eliminate or minimize experiments on animals. There are also ongoing programmes of bioethics education within the republic, including postgraduate training courses for doctors and teachers within medical schools, members of bioethics committees, along with others employed within the healthcare system and representatives of the media. 1.4 Georgia Tbilisi State Medical University in Georgia offers courses in bioethics at both the undergraduate (for medical students) and postgraduate (for resident doctors) level. Both courses are compulsory and constitute an integral part of the study curriculum. The development of bioethics as an interdisciplinary field in Kazakhstan has lead to the revision of the respective educational programmes at all levels. The subject of bioethics as a separate university medical education, but some questions, related to bioethics, were included in the curriculum of other courses. For example, at the Kazakhstan State Medical Academy, questions of of the Department of Public Health. 1.6 Kyrgyzstan 1.7 Moldova For the purposes of teaching bioethics in the Republic of Moldova, the Department of Philosophy of the State Medical and Pharmaceutical University was reorganized into the Department of Philosophy and Bioethics in The new department was responsible for the oversight of all questions related to the teaching of this discipline; this includes the writing of textbooks and training aids, dictionaries, development of thematic plans, curricu-

4 Developing National Systems for Research Ethics Education 291 lums and workshop projects, tests, staff training, methodical and approximately 36 hours of classwork each week. This curriculum methodological studies in the area of bioethics. The Department of stipulates that these institutes must teach history and traditions, Philosophy and Bioethics has developed an online tutorial for theory, models and rules of relationships, patients rights, and the university students, as well as several textbooks and training aids analysis of bioethical issues within experimental medicine, reproon this topic. ductive technologies, euthanasia, transplantology, medical genetics, In addition, the Department carries out ongoing research into HIV infection, ethics in psychiatry and moral issues surround- bioethics using the widest definition of the term (Potter VR, ing the distribution of healthcare resources. personal communication). To date, the Department has organized An important feature of modern biomedical education is also its and held 12 international scientific workshops; scientists and close organizational and methodical association with jurisprupractitioners from many countries and different specialities dence and medical law. The objectives of bioethics and legal (e.g. philosophers, physicians, biologists, environmentalists, engi- training are to identify, formulate and bring to students those neers, economists, agriculturists) have participated in these work- norms of morals and law that will protect their patient and, at the shops and contributed to the development of bioethics in connec- same time, not hinder innovations in medicine. The achievement of these goals is based on a complex, interdisciplinary approach to ogy and other fields of knowledge. the educational process as is required by the essence of bioethics. tion with biomedicine, philosophy, ecology, economics, technol- 1.8 Russian Federation 1.9 Tajikistan the copyright In Tajikistan, biomedical of ethics the is viewed as an interdisciplisystem of organizational and legal support or objective conditions bioethics to be taught within medical training institutions because a discipline must be integrated into the State standard of higher 1.10 Uzbekistan A number of courses have been available since the beginning of the 1990s in the Russian Federation. Separate courses on biomedi- cal ethics were available at Moscow State University within the Departments of Philosophy and Psychology and, since 1994, within the Department of Medicine. In 1994, the teaching of bioethics was introduced at the Moscow Medical Academy. Courses were then introduced in 1996 at the Kazan State Medical University (in the Republic of Tatarstan), Russian State Medical University (in Moscow) and Saint Petersburg State Pediatric Medical Academy (in St Petersburg), and in 1997 at the Moscow Medical Stomatological Institute (in Moscow). In the year 2000, bioethics became a compulsory subject at medical schools in the Russian Federation. The introduction of biomedical ethics into the humanitarian subjects associated with medical education is clear evidence of the importance now given to the humanitarian training of medical students in Russia. Despite the fact that the teaching of bioethics as a specialist subject is only available at the Russian State Medical University, a number of institutes of higher education have departments of bioethics and law in alliance with other disciplines (judicial medicine, history of medicine, philosophy, etc.). In about a third of medical educational establishments, bioethics is taught within departments that cover humanitarian and socioeconomic subjects. In other institutions, teaching and training in bioethics is more cross-departmental, involving also clinicians (clinical pharmacologists, psychiatrists, etc.). A Russia-wide core curriculum for teaching bioethics in medical training institutions was developed in 2001, involving nary field of knowledge, analysing moral problems of human attitudes to living organisms. However, there is currently no for the proper development of bioethics, and bioethics as a special- ized discipline is not included in the education system in Tajikis- tan. However, there is a growing consensus for the need for of the importance of patient-physician communication and the increasing complexity of the ethics involved with the newer biomedical technologies. To achieve this goal, biomedical ethics as education, and general and specialized courses need to be developed. In Uzbekistan, preparatory work has been undertaken for the inclusion of bioethics into the State standard of medical education. Currently, bioethics is taught at the Masters level within the Faculty of Philosophy of the Tashkent State University (specialization ethics ); attention is paid to the problems of bioethics in the programme of the Philosophy of Medicine course at the Masters level in many medical schools. There are no specific courses in bioethics or biomedical ethics currently being taught at medical schools in Uzbekistan, though an elective course is taught at the Tashkent Medical Academy. No specific state-sponsored teaching material has been pub- lished in Uzbekistan for bioethics; however, some material has

5 292 Chaschin et al. been published by individual academics with an interest in the some extent, defended using the reference numbers of other specitopic. It is pleasing to note that, even given the absence of alities such as philosophy, sociology and public health. systematic training in bioethics, the number of specialists contin- While the educational and methodical basis for bioethics in the ues to grow, as too does the quantity of the graduates. region still requires significant development, it is important to note that there is already a range of good monographs and textbooks on 1.11 Ukraine this topic in many countries within Eastern Europe and Central Many institutions of higher medical education now offer elecgaged Asia. Improved cooperation between the various institutions entive courses in bioethics in Ukraine. It is usually taught as part of a in teaching bioethics can also be observed. compulsory course in the philosophy of science and medicine, In 2005, the All-Russian educational and methodological conethics, ethics and deontology of social work and valeology. There ference Biomedical Ethics in Higher Medical Educational Faciliare no specific topics or number of hours required as part of this ties was held; this conference summarized experiences accumulat- training; these depend on the teacher and their views on bioethics ed in the field of bioethics education from various universities and schools. More recently, other post-soviet republics have also held In addition to training in bioethics at medical schools, it is also international conferences, seminars and roundtable discussions taught at universities and polytechnic institutes as part of veterinaproduced dedicated to the methods of bioethics teaching, and these too have ry and other higher education courses. numerous materials, including methodical develop- ments, manuals, dictionaries on bioethics terminology and training and the place it has within their course. programmes on the bioethical education of students at medical 2. A Need to Work Together In the post-soviet world, a different model of bioethics has developed in which bioethics is an interdisciplinary field of know- schools. Nevertheless, there is an obvious need for all CIS countries to perfect the system of training staff for teaching bioethics, providing training aids and, to some extent, standardize the train- ing programmes in higher educational establishments. ledge, analysing the moral issues surrounding human life and attitudes toward living organisms. With this model in place, the aim is now to provide guidelines that firmly establish standards and regulations for clinical research. However, it is also important 3. The Bologna Club to define mans role within this framework and make clear not only including the struggle to identify where in the healthcare curricu- the value of human life but also what constitutes life and death, and an individuals right to have control over both. In the majority of ex Soviet states, bioethics as a standalone subject is not included in the State standards for education and, hence, there is no State system of education in bioethics. Of note, many of these countries still refer to the Interdepartmental Program on Medical Ethics and Deontology, which was published in the Union of Soviet Socialist Republics (USSR) in the s, for evaluating the positives and negatives of establishing a programme in bioethics. In addition, this text is often used as an historical precursory text to the study of bioethics in the region. There is no trade called bioethics listed in the Classifier of Educational Trades or List of Scientific Specialist Trades; therefore, the targeted training of specialists, including specialists with higher qualifications (masters and doctorates) in science, is not provided in the area of bioethics. However, theses or dissertations for masters or doctorate degrees that cover bioethics issues are, to Some of the CIS countries (Azerbaijan, Armenia, Georgia, Moldova, the Russian Federation and Ukraine) have joined the Bologna Club 1 ), [2] This has raised the necessity for bioethics educators to resolve some of the outstanding issues in bioethics, lum the compulsory (rather than optional) study of bioethics should be placed to best meet the requirements of the Bologna Declaration, along with issues surrounding the writing of text- books and other materials for training both students and teachers in the discipline. The existing experiences of teaching bioethics as a subject in different countries allows us to draw the following conclusions. There is a tendency to teach bioethics as the applied biomedical ethics of a narrow professional character. Problems asso- ciated with teaching bioethics in Eastern European countries were raised at the 2005 United Nation s Educational, Scientific and Cultural Organization (UNESCO) seminar in Moscow, where it was mentioned that 70% of those who teach bioethics 1 The Bologna Process, from the Declaration of Bologna, aims to create a European Higher Education Area by 2010, in which students can choose from a wide and transparent range of high quality courses and benefit from smooth recognition procedures. The Bologna Declaration of June 1999 introduced a series of reforms to make European higher education more compatible and comparable.

6 Developing National Systems for Research Ethics Education 293 are physicians with a classical medical education. Thus, the in turn can pass this training on to the next generation of bioethics majority of bioethics teachers have not actually studied ethics students. Some work is being carried out with such an aim. In the as an independent discipline, and this lack of in-depth know- majority of CIS countries, bioethics is now being taught not only ledge must surely have an impact on their interpretation and in medical schools but also in medical institutions for postgraduate teaching of the subject. It was noted that there was a strong need training, universities and other institutes of higher education. to teach bioethics as a special interdisciplinary field, uniting In 2000 the Department of Philosophy at the National Medical features of natural science and humanitarianism. Academy for Postgraduate Studies in Ukraine was one of the first Problems of bioethics, medical deontology and clinical ethics to introduce a compulsory course in bioethics for postgraduate in medical practice can be successfully resolved only if medical students (Bioethics as Modern Medical Ethics). Bioethics has also professionals know and understand the current legislation refer- been included in some other courses offered by the Academy, ring to healthcare. Therefore it is necessary to provide guide- including: lines of medical activity according to new conditions in practi- Sociocultural, Ethical and Deontological Aspects of Physical healthcare, and teach legal knowledge to medical special- cian s Activity for clinical residents; Philosophy of Medicine for PhD students; deontology and medical ethics, along with medical and general Ethics of Biomedical Research for PhD students and PhD law. This also refers to physicians, researchers and administracandidates; tors who are responsible for decision-making in biomedicine and healthcare, as well as the general public. This is a problem cal Research for PhD students, physicians and members of for all the post-soviet states and for many more countries too. ethics committees at research institutes and institutes of higher Even when the level of education in bioethics may seem quite medical education. satisfactory, there is likely to be paternalism. Paternalism, in its turn, roots back to the authoritarian ethics in which the interests take short continuing medical education (CME) courses with of the society, State and science prevail over the interests of an credit hours. These offer the participants a variety of topical issues individual. Therefore it is necessary to form a new humanistic related to the ethics inherent in the doctor-patient relationship, ethical way of thinking, which may be achieved through bioethical education. basic principles of modern medical ethics; In general, one can come to a conclusion on the need for the creation of educational facilities for the organization, design and the rights of patients within the principles of modern medical methodological basis for teaching bioethics. During the last few ethics; years, there has been a trend towards more specialized courses and departments for the teaching of bioethics. At the same time, it has teaching students and residents. become necessary to make efforts to develop state educational There is one more programme specifically for doctoral stu- standards, which in turn have led to standardized and functional dents. This programme is focused on research ethics and covers all educational programmes that comply with scientific and practical requirements, and to coordinate the activities of university depart- In Kazakhstan, the Almaty State Post-Graduate Training ments that teach issues of legal and ethical control in medicine and Medical Institute has established the Department of Health Legis- medical practices. lation and Bioethics, which now organizes a number of different courses related to the ethical standards required in healthcare and 4. Teaching Bioethics healthcare research. In addition to undergraduate courses, several workshops have been conducted for physicians. Many important One of the key prerequisites in setting up a bioethics education topics have been discussed during these workshops, including but system is the need for quality training to provide suitably qualified not limited to: professors and other teachers to educate future students. This historical perspectives of the ethics of scientific research in requires the implementation of a postgraduate education system public health; that includes elements of both research and vocational training so international declarations and manuals on scientific research that educators are given a solid grounding in the topic so that they with human participation; ists. Medical students should have a systematic knowledge of Organization and Performance of Ethical Review of Biomedi- In Georgia, all healthcare professionals have an opportunity to including: protection of confidentiality and privacy in the process of aspects of ethical and legal regulation of biomedical research.

7 294 Chaschin et al. the role of ethical review in biomedical research; the role of SOPs in conducting ethical review; establishing ethics committees; choosing independent consultants; confidentiality agreements. Opportunities for education in the field of bioethics and GCP at an international level are restricted to separate training courses and seminars (including conferences, symposia or congresses and clin- ical research) held by science academies, nongovernmental organizations and institutes of higher medical education. Currently there is no organized system of training in GCP principles. A number of different nongovernmental organizations and as- sociations currently play an essential role in the distribution of bioethical knowledge. The efforts of a number of these organizations has meant that foreign training material has been translated, and books and manuals on teaching bioethics have been written for use in the regions universities and institutes. In addition, a large number of conferences and seminars have been organized, and thematic television and radio programmes broadcast. Organiza- tions within Belarus, Moldova and Ukraine have significantly contributed to this essential work. The success of these programmes in bioethical training is important for a number of reasons, including: 1. the integration of CIS countries into the European and world informed consent; confidentiality; ethics of clinical studies; function of ethical committees; manuals on ethical review; religion and culture in ethics. In the Russian Federation, questions of bioethics are commonly included in postgraduate specialist training courses and training in bioethics constitutes a compulsory component for candidates en- rolled in the Philosophy and History of Science course. This way postgraduate courses for clinicians and researchers include the themes of Methods of Organization and Carrying out of Clinical Research of Medications and GCP. be similarly organized. review. Such training is organized under the auspices of the Forum community; 3. encouraging interconnections and interactions among individ- has been involved in the spread of bioethical knowledge through Postgraduate education in bioethics is also well organized in Moldova and Belarus. Yet in the Central Asian states, the system- atic teaching of bioethical issues at the postgraduate level is yet to The training of ethics committee members plays a key role in bioethical education, the implementation of bioethical principles into everyday practice and the development of a system of ethical for Ethics Committees in the Confederation of Independent States (FECCIS) as well as at the initiative of ethics committees themselves. A number of medical universities and large contract re- search organizations within the region have also been involved in providing training on GCP; courses are commonly aimed at doc- tors and researchers and expanding their general knowledge in regard to the protection of the rights of biomedical research participants. 4.1 Training of Ethics Committee Members the development of training and educational processes and pro- grammes. The integration of these new ethical and legal approaches, principles and values, into the wider society are expected to impact not only on medical research, but throughout society, leading to the enhanced survival of mankind through steady and safe drug development. Since 2001, members of national ethics committees along with regional and local ethics committees have participated in training seminars on bioethics; to date, courses have been held in St Petersburg (Russian Federation), Kiev (Ukraine), Almaty (Kazakhstan), Minsk (Belarus), Chisinau (Moldova), Baku (Azerbaijan), Yerevan (Armenia) and Tashkent (Uzbekistan). Training seminars have been organized by the FECCIS and other international and national organizations. Training seminars on research ethics for committee members have also been conducted within the framework of the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) Recognition Programme. [3] Within these seminars there was training on standard operational procedures (SOPs) and human subjects protection. The training seminars covered the following issues: 2. the formation of moral mechanisms for ensuring the secure development of ethics strategy within the region, as well for further democratization and social activity; uals, society and the environment; that is, in the implementation of one of the significant principles of bioethics co-evolution. A wide array of both state and nongovernmental organizations 5. Summary We can define three levels of bioethical education in the countries of Eastern Europe and Central Asia. The first involves teaching bioethics to medical undergraduates. Such courses aim to promote the formation of a consciously ethical attitude to human

8 Developing National Systems for Research Ethics Education 295 effort is still needed to determine what is required from the 1. Mappes TA, Degrazia D, editors. Biomedical ethics. 5th ed. New York: Macgraw- life and all living organisms. Students are introduced to key and healthcare research, but also to raise the public s expectations conceptual models of bioethics and biomedical ethics, the history of the medical profession in regard to ethics. This is a challenging of their development and current state, and given an understanding task for the various nongovernmental organizations and bioethical of the main concepts and categories. At the end of the course, the associations involved, but we have high hopes for the future. aim is for students to be able to characterize: the essence and basic problems of bioethics and biomedical ethics, their principles and Acknowledgements values behind bioethics; the moral aspects of current issues in modern medicine and biomedical research; apply normative as- This article is a result of collective work of authors representing different pects of ethical knowledge in professional communication; and countries of Eastern Europe and Central Asia, based on both individual make their own moral choices and bear the responsibility. research and common meetings within the framework of the CIS. Dr Zagirtdinova is the Chairwoman of the Central Asian working group The second level involves providing bioethical knowledge to subcommittee on ethics education, Uzbekistan. qualified medical practitioners through raising their professional No sources of funding were used to assist in the preparation of this article. knowledge, postgraduate education and advanced training. Much The authors have no conflicts of interest that are directly relevant to the content of this article. different training programmes in bioethics for medical workers; recommendations for the organization of advanced training courses for members of ethics committees, and medical workers in References general, requires a significant level of coordination, not only in Hill, 2000 regard to the seminars, courses, conferences and written materials 2. The Bologna Process. Towards the European higher education area [online]. involved, but also because of the local, national and international Available from URL: logna_en.html [Accessed 2008 Aug 28] scope of the challenge. 3. Forum for Ethical Review Committees in the Asian and Western Pacific Region. The third level involves providing bioethical education for the general population the most ignored group in this equation. This [Accessed 2008 Aug 28] is the area in which the most significant amount of education is yet to be undertaken. Much work is yet to be done amongst the wider Correspondence: Dr Mykola Chaschin, National Scientific Center for community at a local, national, and trans-cis level as there is Volodymyrska str., Kyiv 30, 01601, Ukraine. great need not only to spread the ideas of ethics within healthcare biomed@nas.gov.ua SIDCER recognition programme [online]. Available from URL: Medical and Biotechnical Research, National Academy of Science, 54