In October 2003 UNESCO Commission of Serbia and Montenegro established the National Committee for Bioethics, consisting of eleven respectful members from Belgrade, Novi Sad, Nis and Podgorica . Four of them are the members of the Serbian, one of the Montenegrin Academy of Sciences and Arts, and six of them are distinguished professors at the Faculties of Science, Medicine or Philosophy.

Activities of our Bioethical Committee have been numerous and versatile, including: (1) Application of Declaration on human genetic data with a surway of situation in biomedical research in scientific and medical centers; (2) An active participation in preparations of the declaration on Universal norms in bioethics (UNESCO/Paris 2004-2005); (3) Acceptance of the initiative of UNESCO/ROSTE from Venice to proceed comparable tests in Serbia, Slovakia and Macedonia (as model-countries), on the levels of the knowledge among medical practitioners about the application and use of molecular biology and genetics in medicine (4) Improvement of national legislation in the fields of biomedical research.

Our Committee is the member of the International Bioethics Committee (IBC) and of the Intergouvernmental Bioethics Committee (IGBC) of UNESCO. In 8^th COMETH meeting in Dubrovnik (May 2005), we joined the thirty National Ethics Committees of the European Council, and accepted “Convention for the protection of human rights and dignity of the human being with regards to the application of biology and medicine” (Oviedo 1997), as well as its additional Protocols “..on the prohibition of cloning human beings” (Paris 1998), “..concerning transplantation of organs” (Strasbourg 2002), and “..concerning biomedical research” (Strasbourg 2005).

The National Committee for Bioethics has proposed that any activities with human reproductive cloning should be prohibited in our country, while allowing research into cloning of human tissues and cells for therapeutic purposes. In a few centers where artificial hybridizaton is proceeded, special rules are publically accepted to satisfy the basic ethical principles which are used in countries with a longer experience in these fields.

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Published in „Bioetics in science and medicine” (2006)

BIOETHICS AT MEDICAL FACULTIES AND IN HEALTH INSTITUTIONS OF SERBIA

Vladisav STEFANOVIC

Serbian Academy of Sciences and Arts, Belgrade

The law on health care in Serbia provided regulation of research on human beings. The main objectives of the regulation are to establish a Central Ethics Committee of Serbia and local ethics committees (at the Clinical Centers and Hospitals).

Ethical committees are composed as to be able to provide complete and adequate review of the research proposals submitted to them. Their membership include physicians, scientists and other professionals such as lawyers, ethicists, as well as lay persons qualified to represent the cultural and moral values of the community and to ensure that the rights of the research subjects will be respected. They include both men and women.

The main role of research ethics committees is to assess both the scientific and ethical aspects of submitted protocols. Ethical committees are responsible not only for approval of the protocol and its amendments but also for follow-up and monitoring of the trial after its closure. This last commitment is rarely fulfilled because of lack of time and resources assigned to the ethics committee.

An analysis of the work of research ethical committee at the University Clinical Center in Nis (Serbia) reveals that major time was devoted to the clinical investigation of drugs, treatment procedures (e.g. hemofiltration, automated peritoneal dialysis, basal/bolus therapy by an insulin preparation), new diagnostic methods, etc.

Clinical investigation of drugs was requested by foreign harmaceutical companies, as a part of international collaborative studies or, more common, as a part of drug registration procedure in Serbia. The benefits of such studies are small for the patients involved, with drug supplied only in the trial period. With a relatively good health care system and inexpensive investigation, Serbia could attract major pharmaceutical companies to seek research collaboration.

A cornerstone in health care is the duty to inform patients not only of their right to partake in decisions about their care but also of the various options for treatment. This applies particularly in clinical research, for which the Helsinki Declaration has defined patients' rights. Informed consent is of great importance both in routine care and in clinical research. Even if information is given to the patient it is not always comprehended. In some studies in Serbia about one half of the patients had misunderstood the information in certain respects.

Clinical research involving healthy volunteers is important for advancing medical knowledge but raises a variety of ethical issues, many of which stem from the fact that such studies pose risks to research participants without the prospect of medical benefits to them.

A worldwide shortage of donor organs has led to the development of national and international systems for organ procurement and allocation. Such systems promote organ donation and ensure fair distribution of available donor organs. National system in Serbia is moderately developed. Organ trafficking and paid organs do not exist in Serbia.

Research involving children or persons unable to give consent, pregnant women or healthy volunteers for clinical trials is very sensitive, and major evaluation is to be done at the central ethical committee of Serbia. The population in Serbia is getting older, and sometimes these old persons cannot understand explanation of a trial before giving informed consent. Clinical trials should not exploit the subjects who agree toparticipate in them. A trial in Serbia might be justified in a numberof ways. The research might address an important health problemin the country, or it might represent a joint effort by thecountry sponsoring or conducting the study and Serbia to address an important health problem in both countries. However,conducting a trial in Serbia because it is moreconvenient or efficient or less troublesome to do so is nevera sufficient justification.When research is to be performed in Serbia, the applicants should also describe the arrangements for: (1) sharing of benefits and allocation of intellectual property rights; (2) contribution to capacity building in Serbia (i.e. capacity to asses and use modern technologies while respecting our own choices, needs and local conditions). The supply of new drugs must be guaranteed after a trial has ended, even for patients’ lifetime if necessary.

Regulation in EU is important to Serbia in the process of accession. Our low should take into account the two directives of EU:

DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001, on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

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Published in „Bioetics in science and medicine” (2006)

GENETIC COUNSELING AS CONTEMPORARY MODEL OF

MOTHER AND CHILD HEALTH PROTECTION

Ljubomir STOJANOV, Marija GUĆ-ŠĆEKIĆ, Žarko PUZIGAĆA, Maja ĐORĐEVIĆ, Božica KECMAN

Institute for mother and child healthcare „Vukan Čupić“

The advancement of modern technology and increasing competences in the filed of inhereted and non-inhereted malformations have allowed modern appraoch towards their prevention, diagnostics and treatment. However, we are far away from our objective to solve this issue long term. This is a consequnce of still unsufficient knowledge within the medical field but also a reflection of limited knowledge of us as individuals who also tend to disregard already established facts. Although inherited diseases are relatively scarce, they jointly represent not only individual problems but also issues of public concern, the more so as the population growth rate is continuously showing a decreasing trend. It is therefore obligatory that with the further development of relevant technology and improvement of economic situation, each individual is given an access to the findings of modern medicine. Moreover, it is crucial that doctors from the primary medical protection, being the key of health protection, are involved in order to prevent birth of disabled descendant.

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Published in „Bioetics in science and medicine” (2006)

ETHICAL ASPECTS OF GENETIC COUNSELING

Aleksandar KRSTIC

Pediatric Clinic, Faculty of Medicine, Novi Sad

Moto: The ethical law protects people from people

Mahabharate

Although general ethical principles have existed since Hippocrates to the present, today, after the Human Genome Project, we have to create and learn about the new ethical codex. Current genetics is making a significant contribution to health promotion and to treating the sick. Thus we expect it not only to «add years to life, but life to years». Genetic counseling (GC), as an important part of clinical genetics, is still underdeveloped in Serbia: there are no official educational programs; GC is available only in four university institutions (Pediatric Clinic in Novi Sad, Mother and Child Institute in N. Belgrade, Pediatric Clinic in Vracar, Pediatric Clinic in Niš) in one hospital in Subotica and in several private clinics and dispensaries in Belgrade, Novi Sad, N. Banovci, Subotica and Kragujevac. Only one genetic counselor is employed in all institutions, providing diagnosis and counseling of other associates, whereas only the Mother and Child Institute in N. Belgrade has a team consisting of a pediatrician, gynecologist and a biologist/geneticist. This paper reviews the organization and work of genetic counseling. Apart from the definition and contents of bioethics applied in all segments of GC, four principles of bioethics are mentioned: act in the best interest of the client conflicts, respect and do not violate one’s integrity, and, be objective. Moreover, three ethical principles are given for the relationship between the counselor and the patient: accuracy of information, secrecy regarding the genetic burden and informed consent. The principles and regulations are applicable to 17 different conditions and situations, according to the instructions of the Japanese Society of Human Genetics from 2001. This is a review of the experiences and activities of the Genetic Counseling of the Pediatric Clinic in Novi Sad, with around 16.000 professional opinions. In the period from 1990 (foundation of prenatal cytogenetical laboratory) to 2003, amniocentesis was performed in 12.210 and cordocentesis in 1.752 pregnant women. In the same period, prenatal diagnosis was performed in 13.962 cases, and 270 (1.93%) fetuses with chromosomal abnormalities were found. After getting genetic information, all pregnant women and their families decided to terminate the pregnancy.

In our opinion, genetic counselors should receive three-year training, and it should be provided at all medical schools and hospitals which have means for diagnosing hereditary diseases. Apart from the existing one-year specialization in medical genetics, proper specialization in clinical genetics, lasting at least 4 years of theory and practice, should be considered.

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Published in „Bioetics in science and medicine” (2006)

STUDY ON AWARENESS OF GENETIC TESTING IN SERBIA & MONTENEGRO

S RADULOVIC^1*, Z MAGIC² M BRANKOVIC-MAGIC¹, R JANKOVIC¹, S.PAJEVIC, D MARINKOVIC², S DOTTORINI³

¹Institute for Oncology and Radiology of Serbia, Belgrade, Serbia & Montenegro

²National Committee of Bioethics of Serbia & Montenegro, Belgrade, Serbia & Montenegro

³UNESCO ROSTE, Venice, Italy

* Program coordinator for Serbia&Montenegro

In order to estimate current status of public and professional i.e. general practitioners’ awareness of genetic testing, pilot program Public and physician awareness of genetic testing in ethnically diverse populations (PPAGET project), created and financially supported from UNESCO Regional Bureau for Science in Europe, was carried out in Serbia&Montenegro during 2005. In the same time, the same program was performed in FYR Macedonia and Slovakia. Program was conducted throughout two specially created questionnaires. In Serbia & Montenegro, survey for lay public was performed in different parts of the country (the biggest mol Mercator S in Belgrade, 1 center from Vojvodina - Novi Sad, 1 from Central Serbia- Raca Kragujevacka, and 1 from Montenegro -Niksic. Data from physicians working in primary health care were gathered in two ways. First, conferences for general practititoners were organized in 6 centers in the different parts of Serbia & Montenegro (Health Center Vozdovac in Belgrade, Kladovo, Jagodina and Gornji Milanovac in Central Serbia, Subotica in Vojvodina and Podgorica in Montenegro). Besides that, questionaires were distributed to directors of additional Health Centers (6 from Central Serbia -Health Centers Uzice, Sabac, Leskovac, Ljig, Boljevac, Pirot, 5 from Vojvodina (Health Centers Novi Sad, Kovin, Vrsac, Sombor i Zrenjanin) ensuring reliable data about physician's awareness of genetic testing.

Results of surveys are data base for lay public (864 questionnaires) and data base for general practitioners (283 questionnaires). The results indicate that lay public is ready and willing to participate – two-thirds of participants are informed about the term “genetic testing”, but half of them do not know whether genetic tests are available for them. Knowledge about genetics is different due to the place of living (Belgrade, city from inside of Serbia or village). Concerning general practitioners, they express their opinion about lacking of adequate knowledge in medical genetics. One-third of general practitioners did not know were to refer the patient for hereditary predisposition testing. Half of physicians do not know if the genetic testing is covered by health care insurance. Even more than 50% of physicians can not guarantee to their patients that the results of their genetic tests will not be divulged to third parties. Their knowledge about hereditary diseases is influenced with the time interval after graduation. In conclusion, in order to improve the knowledge about genetic testing, it is necessary to perform more aggressive campaign for lay public throughout media and to create special educational programs for individuals and families at risk for hereditary disease. Education in medical genetics is also necessary to be performed for medical doctors to help them to recognize individuals at risk for hereditary disorder, to refer them to be tested for a hereditary predisposition appropriately, as well as to inform all their patients about progress in medical genetics.

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Published in „Bioetics in science and medicine” (2006)

RECOMMENDATIONS FOR LEGISLATION OF GENETIC TESTING IN SCIENCE AND MEDICINE

Zvonko MAGIĆ

Institute for Medical Research - Military Medical Academy, Belgrade, Serbia

Just a few years after deciphering the human genome, a range of genetic tests has been developed and the possibility of genetic testing is profoundly changing the methodologies and strategies used in medical therapy and healthcare. Application of genetic testing in research and medicine also encompasses consideration of ethical, legal and social implications. As genetic testing becomes more and more a part of everyday healthcare system, patients and professionals will have to learn to make decisions on the need for the test and also to understand its consequences. In order to help decision makers, the European Commission’s Research Directorate General invited a group of experts from various fields of interest to discus the ethical, legal and social implications of genetic testing and draw up relevant recommendations. The group take in consideration particularly Guidelines for the implementation of the Universal Declaration on the Human Genome and Human Rights which United Nations General Assembly endorsed on 16 November 1999 by 30/C Resolution 23. Welcoming the broad public interest worldwide for genetic testing, the Group recognised the importance of a number of other areas which they did not address, such as the use of genetic testing in insurance, patenting, judicial uses and forensic medicine, human gene therapy and fundamental research of genome. Concentrating on the ethical, social and legal implications of genetic testing the Group developed 25 recommendations organised in three chapters addressing: general framework; implementation of genetic testing in healthcare system; and genetic testing as a research tool. The EU, and also UN give the firm support for further steps in legislation, regulation and implementation of norms, standards and ethical codes in genetic testing procedures.

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Published in „Bioetics in science and medicine” (2006)

MOLECULAR BIOTECHNOLOGY - ETHICAL CHALLENGE OF 21^st CENTURY

Ljubiša TOPISIROVIĆ

Institute of Molecular Genetics and Genetic Engineering, Belgrade, Serbia

Modern civilization is facing many problems in the field of energetic, food production, health care, protection of environment etc. It is expected that most of these problems will be overcome by using accumulated knowledge in molecular biology that resulted in development of genetic engineering and molecular biotechnology based on it. First results of molecular biotechnology are construction of genetically modified organisms (GMO) of all kind. In domain of microorganisms, genetically modified microorganisms (GMM), were constructed which are able to perform various mineral leaching from ore that very often severally endanger environment. Thus, getting metal from ore by cheaper processes and concomitantly remediation of the environment are done in the same time. Among others, GMM are also used for production of biopharmaceuticals, bioplastics and so on.

Plants are growing elsewhere around us. They are used as food, feed as well as decoration. However, the accumulated knowledge related to mechanisms of plant functioning open new possibilities for plants utilization in the future. The main goal of molecular biotechnology is construction of new plant varieties i.e. agricultural plants, because it allows overcoming the genetic barriers existing among different species. Research is focused on the construction of new plant varieties that will give higher yield or have increased nutritional quality. For this purpose transgenic plants are constructed by implementation of foreign genes into plants. Resulting genetically modified, transgenic, plants resistant to insects, viruses, herbicides or which fruits have delayed ripening are already constructed. On the other hand, the molecular biotechnology gives a basis for construction of transgenic plants that will be used as bioreactors for production of new products such as safe, cheep and more efficient vaccines, bioplastics, etc. It is expected that transgenic plants will be important factor in development of new technologies in the recent future.

Up to the introduction of molecular biotechnology in animal husbandry, new animal races were obtained using tedious and time consuming breeding and selection. The role of molecular biotechnology in this field is to make possible construction of transgenic animals with specific economically significant traits. Conventional breeders and molecular biotechnologists alike envision that tomorrow’s transgenic animals will be more efficient at utilizing feed, will have leaner meet, will grow to marketable size sooner, and will be immune to those diseases that today decimate populations and profits. Constructions of transgenic animals are great challenge for molecular biotechnology since such animals will be used as bioreactors. Transgenic sheep, cows and goats were obtained that secrete human proteins in milk. Test showed that biologically active plasminogen activator, urokinase, alpha-1 antitripsin, and human factor IX and lactoferin could be isolated from milk of transgenic animals.

Bearing in mind potentials of molecular biotechnology it is realistic to expect that an increase of production in existing industrial processes will be attained. Besides, molecular biotechnology gives the possibility to open a new industrial era and to develop new processes for production of products that are difficult to obtain in classical way. Therefore, it is not too far to realize that modern biotechnology will be based on GMO and that it will be a basis for development of 21^st century technologies. However, mankind will be faced with many ethical problems related to implementation of GMO in routine agriculture and industry.

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Published in „Bioetics in science and medicine” (2006)

ETHICAL ISSUES AND ACHIEVEMENTS OF HUMAN GENOME PROJECT

Milena STEVANOVIC

Institute of Molecular Genetics and Genetic Engineering, Belgrade, Serbia

The Human Genome Project is having far-reaching consequencea and will define research through the coming decades. It is absolutely clear that fantastic benefits for the humankind will be fully recognized in the future years. Present and future generations of researchers have been provided with detailed DNA information that will be crucial for understanding the structure, organization and function of genes, chromosomes and genomes.

One of the key research areas within the Human Genome Project have been focused on ethical, legal, and social issues research that have been an integral aprt of this project since its initiation. In years to come passionate debates on complex and often contraversial issues related to the gene patening, genetic testing and genetic discrimination are to be expacted.

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Published in „Bioetics in science and medicine” (2006)

ETHICAL ASPECTS OF INVESTIGATION AND REULTS OF UTILIZATION IN

THE FIELD OF GENETICALLY MODIFIED PLANTS

Kosana KONSTANTINOV and Snežana MLADENOVIĆ DRINIĆ

Maize Research Institute „Zemun Polje“, Belgrade

Society has obligations to raise levels of nutrition and standards of living, to secure improvements in the efficiency, of the production and distribution of all food and agricultural products. A more equiatable , ethycally – based food and agriculture system must incorporate concern for three widelly accepted global goals: improved well being, protection of the environment and improved public health. For the milleniums, in the field of food production biotechnology has been used as the fermentation process during bread, bear or chesse production. After biological sciences development, particularly molecular biology and tissue culture, especially during last decades molecular biotechnologies, based on genetic engineering are widelly used in food production and processing. As results, new varieties of commercially grown crops with higher yield are developed, as well as decreassing time to breed new genotypes having satisfactory resistance to different pathogens, tolerance to biotic and abiotic stress conditions etc. As information technology, molecular biotechnology is a „strategic“ technology with the potential to impact many areas of contemporary society and can develope within a context of public support or public may activelly constrain and influence the course of development of new technologies. Impotant issue of molecular bioechnology impact are genetically modified organisms – GMO - , including plants. In reponse to the growing prevalence of GMO in processed foods, wide range of environmental and food safety groups have mounted an active campaign against GMO products. To mitigate conflict one of the approach to solve the problem is ethical and truthful label of GMO food, because consumers have a right to choose whether to eat genetically modified foods or not.

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Published in „Bioetics in science and medicine” (2006)

ETHICAL ASPECTS OF NATIONAL BIOSAFETY COUNCIL ISSUES

Aleksej TARASJEV¹, Oliver STOJKOVIĆ² and Jelka CRNOBRNJA-ISAILOVIĆ¹

¹Institute for biological research, ²Faculty of Medicine, Belgrade

I n this survey we covered a variety of ethical issues connected with modern biotechnology and use of genetically modified organisms (GMO). We present and discuss general ethical concerns regarding GMO that can be found in the media and general public, concerns regarding the possibility of coexistence between GMO on one side and conventional and organic agriculture on the other side, as well as common ethical issues GMO topics share with the more general subject of environmental ethics. Specific ethical issues concerning differences between labeling regulations and practices on one hand and the underlying basis of such regulations (informing the public and choice rights) on the other are also adressed. However, major emphasis is set on ethical questions connected with the work of the independent external expert advisory body – National Biosafety Council, since all authors have their own personal experience in that field.

Experts involved in the Biosafety Council share several ethical issues with members of a range of other expert bodies, as well as with scientists that serve as expert witnesses or participate in peer reviewing proccesses. Those questions involve various subjects of professional ethics such as objectivity, impartiality or integrity. Connected with them are ethical matters involved in “conflict of interest” situations. These questions are of particular interest in small and moderate size countries where we have a greater chance that the Council will receive applications from institutions affiliated with one of its members. Topics of dissenting opinions in Council recommendations, respect for other member’s expertise and opinions, decision by voting in bodies that consist of experts with various fields of expertise are also very important in the work of National Biosafety Council. Subjects of confidentiality and “whistleblowing” should also be covered in ethical considerations.

In this contribution we do not give “final solutions” for most ethical questions that arise in biosafety matters and National Biosafety Council practice, but rather present various ethical considerations in order to facilitate debate and scrutinize those issues both within the scientific community and the general public.

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Published in „Bioetics in science and medicine” (2006)

ETHICS STANDARDS IN THE SCIENTIFIC RESEARCH

Dusica PAVLOVIĆ

University of Niš, Faculty of Medicine

Since knowledge is the property of the whole mankind and since it significantly contributes to general welfare and progress, it is quite clear that science basically aims at truth. A scientist contributes to the general knowledge treasury with his scientific work, being allowed at the same time to use the knowledge of other investigators. International standards, application of scientific methods and behavioural codex for scientific and investigational work are, the necessary pre-requisites to protect science and scientific achievements from all kinds of dishonesty. Well defined rules of conduct in all phases of scientific-investigational work comprise the ethical codex of Good Scientific Practice – GSP. The basic ethical principle which should guide all scientists is scientific honesty, required in all phases of any scientific work: from the hypothesis, choice of appropriate methodology, through to analysis and interpretation of the obtained results, including their publishing. Most scientific achievements cannot be ranked by the factors of their importance and scientific impact, particularly at the moment of their being made publicly accessible. Only when the new knowledge has been associated with the existing one and the one resulting from their fusion, scientific significance becomes fully known and measurable. Therefore, almost none of the new scientific insights and knowledge cannot be said to be redundant and inapplicable. Knowledge is subject to change and its direction and reach cannot be reliably predicted. Thus, the obligation of all scientists and society in general is to create the environment which would support high ethical standards in the scientific-investigational work.

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Dušica PAVLOVIĆ

DECLARATIONS ON GENETIC DATA AND CONVENTIONS ON HUMAN RIGHTS AND BIOMEDICINE