Ethical standards in biomedical research: the acquis and projects of the Council of Europe

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Ethical standards in biomedical research the
acquis and projects of the Council of Europe
Laurence Lwoff Bioethics Division Council of
Europe http//www.coe.int/bioethics 8th Global
Forum on Bioethics in Research, 27 29 June
2007, Vilnius
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Council of Europe

• Intergovernmental organisation founded in 1949,
  to achieve greater unity between its members with
  a view to defend
• Human rights
• Parliamentary democracy
• Rule of law
• 47 countries (all EU member states also CoE
  members)
• Observer status Canada, Holy See, Japan, Mexico,
  United States

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Activities of the Council of Europe in the field
of bioethics

• To find the necessary balance between scientific
  /medical progress and protection of the human
  being
• Normative activities
• defining fundamental principles ensuring this
  balance
• Cooperation activities
• helping country implementing those principles
  (e.g. meetings, publication, expertises)

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Activities of the Council of Europe in the field
of bioethics biomedical research

• Acquis
• Legal instruments
• Cooperation activities
• Projects

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Biomedical researchrelevant CoE legal instruments

• Convention on Human Rights and Biomedicine
  (Oviedo, 04.04.1997)
• Additional Protocol on Biomedical Research
  (25.01.2005)
• Recommendation on Research on Biological
  Materials of Human Origin, Rec (2006) 4
  (15.03.2006)

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European instruments but

• Normative corpus reflecting European consensus,
  but
• International dimension of research taken into
  account
• Values and derived principles have vocation to
  contribute to general consideration at
  international level

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Biomedical researchConvention on Human Rights
and Biomedicine

• Fundamental principles
• Free, informed, express, specific and documented
  consent
• Research shall be carried out freely, subject to
  provisions ensuring protection of the human
  being.
• Some specific conditions
• Approval by the competent body after independant
  examination of scientific merit, including
  independent multidisciplinary review of ethical
  acceptability

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Biomedical research Additional Protocol on
biomedical research

• Covers full range of research activities
  involving interventions on human being (including
  recruitment of research participants)
• Builds on the principles of the Convention and
  complements its provisions
• In particular
• Informed consent type of information to be
  communicated to the person
• Confidentiality
• Research in specific situations emergency
  situation, pregnant women, persons deprived of
  liberty
• Transparency publication of all results

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Biomedical research Additional Protocol on
biomedical research

• Ethical review Ethics committee (Articles 9 to
  12)
• Any research project submitted for independent
  ethical review by an ethics committee, in each
  state in which any research activity is to take
  place
• Ethics committee
• independance, no undue external influences,
  declaration of conflict of interests, appropriate
  range of expertise, professional and lay views
• information to be provided for evaluation of a
  research project (Appendix)
• Recommendation on research on biological materials

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Biomedical research Additional Protocol on
biomedical research

• Equivalent protection of all participants in
  research including in countries not bound by the
  Protocol (Article 29)
• Sponsors or researchers within jurisdiction of a
  Party to ensure that research project planned in
  a State not Party complies with the principles of
  the Protocol.

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Cooperation activities DEBRA (Demo-Droit Ethical
Review of Biomedical Research Activity)

• Objectives
• To promote ethical principles in biomedical
  research
• To foster the development of independent and
  multidisciplinary ethics committees for review of
  biomedical research projects.
• Multilateral, regional, bilateral meetings on
  biomedical research ethics, in particular ethical
  review of research projects and functioning of
  ethics committees
• Publication/Code of good practices e.g. Ethical
  Review of Biomedical Research in Europe
  Suggestions for best national practices , by
  Prof. Povl Riis
• Legal expertise

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PROJECTS

• Objective
• raising awareness on ethical principles and
  facilitating their effective implementation
• Cooperation activities
• Regional/bilateral meetings
• Comprehensive programme focusing on one country
• Developments of guide(s) intended for research
  ethics committee members, scientists, health
  professionals
• Pedagogical tool on ethics of biomedical research

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Conclusions

• Development of a whole set of legal instruments
  addressing ethical issues raised by biomedical
  research which are the only legally binding
  instruments at international level
• Definition of a framework for the protection of
  human rights and fundamental freedoms in the
  field of biomedical research
• Normative activity accompanied by cooperation
  activities in Central and Eastern European
  countries to promote ethical principles in
  biomedical research
• Current projects include
• Further development of these cooperation
  activities
• Elaboration of texts intended for health
  professionals, researchers and research ethics
  committee members.
• Pedagogical tool
• Council of Europe ready to share its experience
  in this field and to collaborate with other
  organisations and bodies