National and local ethics committees: CEE perspective

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National and local ethics committees CEE
perspective

• E. Gefenas, D. Jankauskaite
• Vilnius University, Department of Medical
  History and Ethics

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1.1. Do not know how to solve the problem?
Establish an ethics committee...

• When does it work?
• When does it only imitate the problem solving?
  (Ethics committees and countries in transition a
  figleaf for structural violence? R.A. Ashcroft,
  2005)
• Copying the models from other countries - Late
  twin phenomenon?
• Differences and similarities between Western
  European and CEE countries

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1.2. Institutions

• National ethics committees (NECs)
• Local ethics bodies
• Research ethics committees (RECs Regional or
  IRBs)
• Hospital ethics committees (HECs)
• Do we have a model of a good ethics committee?

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1.3. Main features

• Independent, multidisciplinary, pluralist bodies
• Affiliation
• Functions
• Availability of information

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2.1. NECs independence and affiliation

• in the NMS NECs are most often affiliated to the
  Ministry of Health (or Social Affairs)
• meaning of NECs independence if it is
• Funded by non-governmental agencies (e.g., UK)
  vs.
• affiliated to a particular Ministry or other
  governmental body

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2.2. Establishment of NECs in Europe

• First NECs established in the eighties but some
  even in the seventies!
• Majority of the NECs established in the nineties
  and in the beginning of the XXI century both in
  the new and the old EU member states
• However, different status and type of
  activities...

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2.3. Dates of establishment
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2.4. NECs - Functions

• Main functions are very similar all over Europe
• Opinions/recommendations on bioethical issues
• Facilitation of public debate
• Participation in the legislative actions
• However, review of human research projects is
  rather common in the NMS (new member states
  (members from 2004))

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2.5. NECs and ethical review of human research
projects

• Most of the biomedical research - Slovenia
• Multicenter studies Lithuania
• Specific projects e.g., human genome in Latvia
• Appeal body Poland
• Clinical drug trials and medical devices
  Croatia

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2.6. NECs - availability of information on

• Structure
• budget, secretariat, affiliation
• criterion of membership and composition
• Functions and mandate
• Publications
• Opinions, recommendations/statements, annual
  reports

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2.7. Sources of information on NECs

• Availability of information on the www
• in national language
• In English
• Other sources of information
• Fuchs M., National ethics councils. Their
  backgrounds, functions and modes of operation
  compared, 2005, Nationaler Ethikrat, Berlin
• Ahvenharju S., Halonen M., Uusitalo S., Launis
  V., Hjelt M., Comparative anglysis of opinions
  produced by NATIONAL Ethics Councils, Contract No
  RTD-C3-2004-TOR1 Final Report, 2006, Finland
• http//www.privireal.org/index.php

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2.8. Availability of information on the internet
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2.9. NECs General tendencies in NMS

• Problematic role in facilitating public
  understanding/debate on bioethical issues -
  rather few opinions/recommendations
• Additional functions taken by NECs (ethical
  review of BR)
• Limited secretariat support
• Limited openness to the international community

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2.10. NECs General tendencies in NMS

• About 1/3 of NECs do not have their websites
• very few committees have informative websites in
  English, e.g., none of the NECs (except Cyprus)
  provide English translations of their publications

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3.1. RECs

• Seems to be the most universal type of local
  ethics institutions accross Europe due to the
  international research ethics guidelines
• However, structures/systems of ethical review are
  very different even in the socio-economically
  similar societies, e.g., the Baltic states
• Difficulties to collect information about
  specific features of RECs functioning

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3.2. Diversity of RECs systems

• Lithuania 2-tier system of ethical review of
  multicenter protocols 1 National Committee plus
  two regional RECs
• Latvia - 7 RECs and the National one only takes
  specific projects (genome project)
• Estonia 2 RECs based at the universities
• Difficulties to obtain information by public on
  the functioning of RECs

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3.3. RECs Regional or Institutional

• The EFGCP Report on The Procedure for the
  Ethical Review of Protocols for Clinical Research
  Projects in Europe (Update March 2008)
• Question 16. How is the independence of members
  ensured? Answer from one of the member states
• Mainly by an appeal to their conscience. ..

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3.4. RECs Asymmetry of ethical review

• Divergence of regulations increases as we go from
  clinical drug trials to other types of
  biomedical research - to non-biomedical human
  research
• More stringent regulations for clinical drug
  trials and medical devices research because of
  the EU regulations

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3.5. RECs Physicians acting as researchers in
industry sponsored research

• One of the most important conflicts (enforced by
  a double role of a doctor) at least in CEE
• Physicians salaries are a few times smaller than
  those in Western/Northern Europe
• E.g., a newly qualified Hungarian doctor earns
  about 500 Euro which is less than a quarter of a
  similar salary in the UK (W. Underhill, 2006,
  MSNBC.com)
• It seems that the payments for researchers
• would significantly exceed the compensation for
  their clinical work (with their own patients!) or
  university initiated research
• Often these are direct payments

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3.5. RECs Other challenges

• Emphasis on procedures
• Lack of systematic training
• Coping with the conflict of interest
  particularly important in CEE

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4. Concluding questions

• Socio-cultural context significantly shapes the
  structure and functioning of ethics bodies in
  Europe
• Why does the NECs functioning is different in
  the old and new member states?
• How could the CEE RECs avoid becoming a
  figleaf for structural violence?

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NEC s in the EU countries I

• Austria - Bioethics Commission at the Ferderal
  Chancellery
• http//www.bundeskanzleramt.at/site/4070/default.
  aspx
• Belgium - Belgian Advisory Committee on bioethics
  
• https//portal.health.fgov.be/portal/page?_pageid
  56,8546420_dadportal_schemaPORTAL
• Cyprus - National Bioethics Committee
  http//www.bioethics.gov.cy/Law/cnbc/cnbc.nsf/DMLi
  ndex_en/DMLindex_en?OpenDocument
• Czech Republic 1. Central Ethics Committee of
  the Ministry of Health - no website
• 2. Bioethical Commission Associated to the
  Research and Development Council of the
  Government - http//www.vyzkum.cz/FrontClanek.aspx
  ?idsekce15908
• Denmark - The Danish Council of Ethics
• http//www.etiskraad.dk/sw293.asp
• Estonia - Estonian Council on Bioethics
• no official website, only http//eetika.ut.strukt
  uur.ee/260511
• Finland - The National Advisory Board on Health
  Care Ethics
• http//www.etene.org/
• France National Consultative Ethics Committee
  for Health and Life Sciences
• http//www.ccne-ethique.fr/?langue2
• Germany - German Ethics Council
• http//www.nat-ethikrat.de/en_index.php
• Greece National Commission on Bioethics
• http//www.bioethics.gr/index.php?category_id3

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NEC s in the EU countries II

• Italy - National Bioethics Committee
• http//www.palazzochigi.it/bioetica/eng/index.htm
  l
• Latvia - Central Medical Ethics Committee
• no website
• Lithuania - Lithuanian Bioethics Committee
• http//bioetika.sam.lt/index.php?1462798423
• Luxembourg - National Consultative Ethics
  Commission for health and life sciences
• http//www.cne.public.lu/
• Malta - Bioethics Consultative Committee
• http//www.gov.mt/frame.asp?l2urlhttp//www.sa
  hha.gov.mt/pages.aspx?page67
• Netherlands - The Health Council of Netherlands,
  Standing Committee on Medical Ethics and Health
  Law
• http//www.gr.nl/ethiek.php
• Poland 1. Medical Ethics Committee -
  http//www.nil.org.pl/xml/nil/wladze/nil_eng/supre
  me
• 2. Bioethics Appeals Commission -
  http//www.kb.mz.gov.pl/index_en.html
• Portugal - National Council of Ethics for the
  Life Sciences
• http//www.cnecv.gov.pt/cnecv/en/
• Romania National Research Ethics Council
• no website
• Slovak Republic - Ethics Committee of Ministry of
  Health