BIOETHICS COMMITTEES AND BIOETHICS EDUCATION IN LATVIA

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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
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ETHICS COMMITTEES

• Established
• Terms
• Aims
• Members
• Activities
• Requirements
• Problems

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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

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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)

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CENTRAL MEDICAL 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

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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

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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
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CENTRAL MEDICAL ETHICS COMMITTEE OF LATVIA
MAIN REQUIREMENTS

• 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

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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

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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
Scientists unacceptable behaviour Conflict of
interest
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ETHICS COMMITTEE OF SCIENTISTS

• ACTIVITIES

• Evaluation of applications, assessment of
  situation, meeting with invited persons involved
• Opinion is given for publication in the Zinatnes
  Vestnesis (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
  SCIENTISTS CODE OF ETHICS

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ETHICS COMMITTEE OF SCIENTISTS  

• SCIENTISTS CODE OF ETHICS
• Riga, Latvia (issued 1997)

1.         General principles of scientists
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.
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ETHICS COMMITTEE OF SCIENTISTS
 

• PROBLEMS
• Committees opinion and its publication in
  Zinatnes Vestnesis (Science Herald) is not
  effective enough to change scientists reputation
  in our scientific community
• Conflicts of interest are unavoidable at the
  present time in Latvia with its small number of
  active scientists (lt 2000) and extremely low
  financing for science (0.15-0.18 from the GDP)

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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)

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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
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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,
• recommendations and
• directives
• of the European Council (Directive 86/609/EEC)
  and European Convention ETS 123 Protection of
  vertebrate animals used for experimental and
  other scientific purposes, which concern the
  requirements for the competence levels of
  experimentators and standardized breeding
  facilities, laboratory animals and experimental
  laboratories.

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ETHICS COMMITTEE 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.
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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

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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).

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• 3Rs

Reduction Replacement Refinement
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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)

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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 3 yrs experience - persons
responsible for directing animal
experiments Level 4 (Category D) higher manager
on specialization - laboratory animal science
specialists
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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)

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EDUCATION COURSES

• ORGANIZATION OF COURSES IN LABORATORY ANIMAL
  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, Jurmala, Latvia.
• Category B, for technicians from Eastern European
  countries, October 2002, Riga, Latvia.
• NATIONAL COURSE, Category C (Balt-LASA
  together with the University of Latvia), 1994.

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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

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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 Freedomand
  Responsibility, Amsterdam, Holland
• 2001, UNESCO 31st Conference. Round table
  Bioethics Impact in Science

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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)

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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

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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

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

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How to reach a high level of competence in
bioethics ?

• PROBLEMS
• Few lecturers of 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

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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?

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• Anticipated results of the suggested
• education model

• accelerated harmonization of the development of
  competence and the establishment 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