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BIOETHICS COMMITTEES AND BIOETHICS EDUCATION IN LATVIA

BIOETHICS COMMITTEES AND BIOETHICS EDUCATION IN LATVIA. VIJA KLUŠA Department of Pharmacology, Faculty of Medicine, University of Latvia, Riga, Latvia. Turku, November 12-13, 2004. ETHICS COMMITTEES. Established Terms Aims Members Activities Requirements Problems.

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BIOETHICS COMMITTEES AND BIOETHICS EDUCATION IN LATVIA

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  1. BIOETHICS COMMITTEES AND BIOETHICS EDUCATION IN LATVIA VIJA KLUŠA Department of Pharmacology, Faculty of Medicine, University of Latvia, Riga, Latvia Turku, November 12-13, 2004

  2. ETHICS COMMITTEES • Established • Terms • Aims • Members • Activities • Requirements • Problems

  3. ETHICS COMMITTEES • CENTRAL MEDICAL ETHICS COMMITTEE • ETHICS COMMITTEE OF SCIENTISTS • ETHICS COMMITTEE ON DRUG CLINICAL TRIALS • ETHICS COMMITTEE FOR LABORATORY ANIMAL USE IN BIOMEDICAL EXPERIMENTS • LOCAL ETHICS COMMITTEES AT HOSPITALS, FACULTIES, INSTITUTES • COUNCIL FOR ETHICAL TREATMENT OF ANIMALS IN LATVIA

  4. CENTRAL MEDICAL ETHICS COMMITTEE OF LATVIA Independent national panel whose purpose is to review and coordinate all activities of biomedical research and new medical therapies where human beings, tissues or cells are used or are the object. This committee reviews scientific studies involving: • Living human beings • Human cells, organs, embryo, foetus • Genome program • New medical technologies • (Clinical trials of drugs and pharmaceutical products)

  5. CENTRALMEDICAL ETHICS COMMITTEE OF LATVIA • ESTABLISHED: in 1998 by the Republic of Latvia Cabinet of Ministers; legal basis of the Committee is a Statute of the Cabinet of Ministers of Latvia • TERM: 4 years • AIMS: Harmonisation and coordination of bioethical issues in accordance with the CE and EU documents • MEMBERS: 14, from organizations representing physicians, nurses, scientists, pharmacists, lawyers, clergy, disabled, retired Recruitment through nomination by the Ministry of Welfare, membership confirmed by the Cabinet of Ministers Cabinet of Ministers appoints a Chairman Members of Committee elect Vice-chairman The Vice-chairman executes the authorities of the Chairman in his/her absence

  6. CENTRAL MEDICAL ETHICS COMMITTEE OF LATVIA ACTIVITIES: • Harmonisation of CE and EU documents • Main topics in biomedical research: • *evaluation of scientific projects • *evaluation of devices • * recommendations for refining experimental techniques and/or procedures • Committee reviews about 25-30 applications per year. • Monthly meetings • Committee releases its views as opinionsand/or recommendations in writing form within 4 weeks

  7. CENTRAL MEDICAL ETHICS COMMITTEE OF LATVIA ACTIVITIES: EDUCATION: 1. Courses for members: * CE courses (every each year) * Courses and meetings suported by Norwegian government and the Nordic Council of Ministers 2. Lectures made by members for * undergraduate students, doctoral students, postdocs * Presentations in TV, radio, newspapers, meetings

  8. CENTRAL MEDICAL ETHICS COMMITTEE OF LATVIA • Patients’ (closest relatives, guardian or donor) written consent agreeing to involvement in the research • Information will be given to, and consent obtained from the closest relatives, guardian or donor when the study is performed in circumstances where patient is unable to consent (infants, unconscious, etc.) • Information for patients about procedure, risks, measures, advantages • Full description of procedures • CV of the principal investigator and main participants • Consent from the head of the institution where the project will be performed • Expertise from relevant professional association (if necessary) • Insurance Statement MAIN REQUIREMENTS

  9. CENTRAL MEDICAL ETHICS COMMITTEE OF LATVIA PROBLEMS: • Committee is not financially supported • No legal basis for sanctions • Difficult to follow-up on adherence to bioethical principles • No certification of committeee members • Committtee is not accreditated • No possibility to control local committees

  10. ETHICS COMMITTEE OF SCIENTISTS ESTABLISHED:in 1998 by the Latvian Academy of Sciences (LAS) and the Latvian Council of Science (LCS) TERM:5 years MEMBERS: 5, recruitment based on nomination by LAS and LCS (mostly members of the LAS) “Rotating” chairman, elected by members for 1 year term. AIMS: The main items to evaluate: * Scientific misconduct (fabrication/falsification of data); * Plagiarism, theft of intellectual property * Scientist’s unacceptable behaviour * Conflict of interest

  11. ETHICS COMMITTEE OF SCIENTISTS ACTIVITIES: • Evaluation of applications, assessment of situation, meeting with invited persons involved • Opinion is given for publication in the “Zinātnes Vēstnesis” (Science Herald) issued monthly under auspices of the Latvian Academy of Sciences, Latvian Council of Science, Latvian Union of Scientists • Organisation of open discussions at scientists meetings on ethical issues according to the SCIENTIST’S CODE OF ETHICS

  12. ETHICSCOMMITTEE OF SCIENTISTS SCIENTIST’S CODE OF ETHICS Riga, Latvia (issued 1997): 1. General principles of scientist’s ethics (principles of human kind and his professional activities); 2.          The scientist as originator; 3.          The scientist as teacher and originator of scientific “school”; 4.          The scientist as referee; 5.          The scientist as expert; 6.          The scientist as partner in scientific discussion; 7.          The scientist as promoter of science; 8.          The scientist as member of society.

  13. ETHICS COMMITTEE OF SCIENTISTS PROBLEMS: • Committee’s opinion and its publication in “Zinātnes Vēstnesis” (Science Herald) is not effective enough to change scientist’s reputation in our scientific community • Conflicts of interest are unavoidable at the present time in Latvia with its small number of active scientists (< 2000) and extremely low financing for science (0.15-0.18% from the GDP)

  14. ETHICS COMMITTEES ETHICS COMMITTEES ON DRUG CLINICAL TRIALS (since 1997) deals with an assessment of drug activities in clinical use LOCAL ETHICS COMMITTEES AT HOSPITALS, FACULTIES, INSTITUTES (since 1997/1998) COUNCIL FOR ETHICAL TREATMENT OF ANIMALS IN LATVIA: (since 2002)

  15. COUNCIL FOR ETHICAL TREATMENT OF ANIMALS IN LATVIA Founded: in 2001 Term: 2 years Aim: to analyse and evaluate situation in animal welfare in Latvia, to inform Governmental institutions about these issues, prepare recommendations; to propose documents concerning animal protection; to participate in the education of society on ethical issues Members: 10, representatives from Latvian Society of Veterinary Medicine, Riga Zoo, Ministry of Environment, Latvian Federation of Kinologists, Latvian animal protectionists, Veterinary and Food Departments of the Ministry of Agriculture, Balt-LASA, etc. Activities: in progress

  16. ETHICS COMMITTEE FOR LABORATORY ANIMAL USE IN BIOMEDICAL EXPERIMENTS ESTABLISHED: in 1994, affiliated at the Latvian Council of Science • MAIN AIMS: • to implement in Latvia the • regulations, • recommendationsand • directives • of the European Council(Directive 86/609/EEC) andEuropeanConvention ETS 123 “Protection of vertebrate animals used forexperimental and other scientific purposes”, which concern the requirementsfor thecompetence levels of experimentators and standardized breeding facilities, laboratory animals and experimental laboratories.

  17. ETHICSCOMMITTEE FOR LABORATORY ANIMAL USE IN BIOMEDICAL EXPERIMENTS Task: to evaluate scientific projects (which propose to use laboratory animals in experiments) before they receive financing from the Latvian Council of Science.

  18. ETHICS COMMITTEE FOR LABORATORY ANIMAL USE IN BIOMEDICAL EXPERIMENTS • Members (13-15) are representatives of: • Latvian Council of Science; • Laboratory animal breeders; • Laboratory animal users from different research institutions and University of Latvia; • Environmental and animal protection organisations; • Balt-LASA; • State Drug Agency; • State Veterinary Department. • Chair is elected by members for 3 years

  19. ETHICS COMMITTEE FOR LABORATORY ANIMAL USE IN BIOMEDICAL EXPERIMENTS • ACTIVITIES: • To give recommendations and consultations to the researchers or any expert (constructive discussions how to write protocols for the experimental setup and design); • To supply the scientific community with the newest information concerning current Good scientific practice. • To cooperate with animal breeding facilities and research institutions regarding any issue related to laboratory animals; • To reduce as much as possible the number of laboratory animals used, to minimize their discomfort, pain and stress (use of analgesia, anaesthesia, euthanasia); • To promote development and use of alternative methods (3Rs).

  20. 3Rs: Reduction Replacement Refinement

  21. ETHICS COMMITTEE FOR LABORATORY ANIMAL USE IN BIOMEDICAL EXPERIMENTS REQUIREMENTS: Scientists are required to present the preliminary protocol in accordance to the Good Scientific Practice (description of the procedure)

  22. EDUCATION IN BIOMEDICAL ETHICS ETHICS COMMITTEE FOR LABORATORY ANIMAL USE IN BIOMEDICAL EXPERIMENTS COMPETENCE LEVELS: Level 1 (Category A) – basic level - persons taking care of animals Level 2 (Category B) – Level 1 with at least 2 yrs experience - persons carrying out animal experiments (technicians) Level 3 (Category C) – Level 2 plus at least 3yrs experience - persons responsible for directing animal experiments Level 4 (Category D) – higher manager on specialization - laboratory animal science specialists

  23. EDUCATION: COURSES Course for Category C: • 80-hr programme (10 days) (about 40 hrs lectures + 40hrs practice) • Examination • Certificates Lecturers: outstanding specialists from different European countries (as well as the USA)

  24. EDUCATION: COURSES • ORGANIZATION OF COURSES IN LABORATORYANIMAL SCIENCE IN CENTRAL AND EASTERN EUROPEAN COUNTRIES • INTERNATIONAL COURSES: • ICLAS/FELASA Courses organized under auspices of the European Comission DG XI: • Category C, for scientists from Eastern European countries • October 16-23, 1999, Jūrmala, Latvia. • Category B, for technicians from Eastern European countries, October2002, Riga, Latvia. • NATIONAL COURSE,Category C (Balt-LASA together with the University of Latvia), 1994.

  25. EDUCATION: COURSES • PARTICIPATION IN THE NORDIC-BALTIC COURSES(Sponsored by Nordic Council of Ministers): • 1994, 1997, Tartu, Estonia • 1996, 1999, Trakai, Lithuania • 2001, St.Petersburg, Russia • 2003, Archangelsk, Russia • OTHER COURSES: • Oslo, Norway, 1993; • Utrecht, Netherlands, 1994, 1995; • Elective course in the Uppsala University, 1997

  26. EDUCATION: CONGRESSES/CONFERENCES • 1996, 2nd World Congress “Alternatives and Animal Use in Life Sciences”, Utrecht, Netherlands • 1997, Congress “Ethics in Animal Experimentation”, Brussels, Belgium • 1997, ALLEA Conference “Science: FreedomandResponsibility”, Amsterdam, Holland • 2001, UNESCO 31st Conference. Round table “Bioethics: Impact in Science”

  27. EDUCATION IN BIOMEDICAL ETHICS University of Latvia: Faculty of Medicine(undergraduate students), Faculty of Biology(masters students), Non-biomedical faculties(course C) All faculties (PhD fellowship students)

  28. EDUCATION IN BIOMEDICAL ETHICS University of Latvia: COURSE: INTRODUCTION TO BIOMEDICAL ETHICS Lectures involve information on: • ethics as a subject of science, philosophy and law; • respect for human dignity, individual freedom and social rights; • the main guidelines and documents on the involvement of human beings in research (Nuerenberg Code, Helsinki Declaration, Strasbourg Conventions etc); • assessment of risks; • new technologies in medicine;

  29. EDUCATION IN BIOMEDICAL ETHICS University of Latvia: COURSE: INTRODUCTION TO BIOMEDICAL ETHICS • human tissues, embryos; gene therapy; cloning: protection of genome data; • ethics committees; • laboratory animal use in biomedicine; models and transgenic animals design of experimental setup 3Rs biostatistics • ethics review process

  30. MODEL COURSES AND TRAINING MODULES ?Main aim:to reach a high level of competence in bioethics

  31. How to reach a high level of competence inbioethics? PROBLEMS: Few lecturersof high competence having knowledge and deep understanding of ethical matters in many disciplines related to: • medicine and healthcare • research (studies in human beings) • studies in laboratory animals • new technologies and methods • social organization and politics • environment • mass media • business work

  32. How to reach a high level of competence in bioethics? How to realize this aim? • Need for harmonized European programmes in bioethics • (Guidebooks for different competence levels ?) • 2.Education in international courses and workshops according to • elaborated programmes for different competence levels • 3. International Bioethics Chairs? • 4. PhD fellowship programmes? • 5. Invited lecturers?

  33. Anticipated results of the suggested education model: • accelerated harmonization of the development of competence and theestablishment of research positions in bioethics • increasing number of persons-professionals who may educate non-scientific community, which becomes confused when faced with the newest developments and having no understanding of scientific problems • mobilising intellectual and cultural resources for political decision-making processes in individual countries and in the world

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