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

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Title: Ethical Questions on Human Genetics Author: lwoff Last modified by: Eugenijus Created Date: 11/25/2005 9:51:43 AM Document presentation format – PowerPoint PPT presentation

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


1
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
2
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

3
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)

4
Activities of the Council of Europe in the field
of bioethics biomedical research
  • Acquis
  • Legal instruments
  • Cooperation activities
  • Projects

5
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)

6
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

7
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

8
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

9
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

10
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.

11
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

12
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

13
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
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