Emmanuelle Rial

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  • Parler ici de Bovenberg et de Herbert
  • Rellying on national experts networks and producing various docments or tools of interest for the BBMRI community, the challenge is to build this community WP6 is a ressource
  • We will ave to share agreed principles. These principles will have to be continuously discussed and to be realistic
  • Similarities and differencies
  • Emmanuelle Rial

    1. 1. A. Cambon-Thomsen and E. Rial-Sebbag BBMRI WP6
    2. 2. <ul><li>WP leader Anne Cambon-Thomsen (INSERM, Toulouse), Assist. Emmanuelle Rial-Sebbag (INSERM) </li></ul><ul><li>Co-leaders/Participants </li></ul><ul><li>Legal pathways Institute for Bio-Law (LP), NL, Jasper Bovenberg (jurist) </li></ul><ul><li>Center for Economics and Social Aspects of Genomics, Cardiff University, (CU), UK, Ruth Chadwick (philosopher) </li></ul><ul><li>Life Science Governance Institute, (LSGI), Herbert Gottweis (political scientist) </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    3. 3. <ul><li>To design an ethical, legal and social framework for the establishment of BBMRI </li></ul><ul><ul><li>agreed, </li></ul></ul><ul><ul><li>harmonized </li></ul></ul><ul><ul><li>implementable </li></ul></ul><ul><li>To propose corresponding strategies and scenarios </li></ul><ul><ul><li>operational concept </li></ul></ul><ul><ul><li>contractual agreements. </li></ul></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    4. 4. <ul><li>D6.1 : Report on ethics related policies for biobanks and biomolecular resources in countries of BBMRI (mo 9) Inserm - CU </li></ul><ul><li>D6.2 : Design of legal WIKI+ platform (mo 8) – LP - Inserm </li></ul><ul><li>D6.3 : Launch of legal WIKI+ platform and mobilising BBMRI stakeholders (mo 14 ) - LP - Inserm </li></ul><ul><li>D6.4 : Background document on harmonization from an ethical point of view (mo 12) CU - Inserm </li></ul><ul><li>D6.5 : Background document on how BBMRI should address its social dimension (mo 17) LGSI - Inserm </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    5. 5. <ul><li>D6.1 : Report on ethics related policies for biobanks and biomolecular resources in countries of BBMRI (mo 9) Inserm - CU </li></ul><ul><li>D6.2 : Design of legal WIKI+ platform (mo 8) – LP - Inserm </li></ul><ul><li>D6.3 : Launch of legal WIKI+ platform and mobilising BBMRI stakeholders (mo 14) - LP - Inserm </li></ul><ul><li>D6.4 : Background document on harmonization from an ethical point of view (mo 12) CU - Inserm </li></ul><ul><li>D6.5 : Background document on how BBMRI should address its social dimension (mo 17) LGSI - Inserm </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    6. 6. <ul><li>D6.6 : Schema of a conceptual model of governance applicable to a pan-European infrastructure for ELSI issues (mo 20 ) Inserm-all </li></ul><ul><li>D6.7 : Uploading and validation of documents of BBMRI Members and Partners on platform (mo 20) - LP - Inserm </li></ul><ul><li>D6.8 : Strategic plan and scenarios for BBMRI interactions with various publics (mo 22 ) LSGI - Inserm </li></ul><ul><li>D6.9 : Flow chart of an operational integrated ELSI governance model (mo 27 ) Inserm-all </li></ul><ul><li>D6.10: Overall report and Recommendations for BBMRI ELSI, including educational proposals (mo 28 ) Inserm - all </li></ul><ul><li>D6.11 : Implementation and monitoring of gender issue plan (mo 28 ) - CU - LSGI </li></ul><ul><li>D6.12 : Final report (mo 29 ) Inserm - all </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    7. 7. <ul><li>D6.6 : Schema of a conceptual model of governance applicable to a pan-European infrastructure for ELSI issues (mo 20 ) Inserm-all </li></ul><ul><li>D6.7 : Uploading and validation of documents of BBMRI Members and Partners on platform (mo 20) - LP - Inserm </li></ul><ul><li>D6.8 : Strategic plan and scenarios for BBMRI interactions with various publics (mo 22) LSGI - Inserm </li></ul><ul><li>D6.9 : Flow chart of an operational integrated ELSI governance model (mo 27) Inserm-all </li></ul><ul><li>D6.10: Overall report and Recommendations for BBMRI ELSI, including educational proposals (mo 28) Inserm - all </li></ul><ul><li>D6.11 : Implementation and monitoring of gender issue plan (mo 28) - CU - LSGI </li></ul><ul><li>D6.12 : Final report (mo 29) Inserm - all </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    8. 9. <ul><li>WP 6 is a « box » of competencies (Ethics, law and social issues) </li></ul><ul><li>National experts network </li></ul><ul><li>Documents and tools (e.i. Legal WikiPlateform) </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009 BBMRI Community
    9. 10. <ul><li>Building the BBMRI Community </li></ul><ul><li>Agreed principles </li></ul><ul><li>Principles in « action » </li></ul><ul><li>Communication formalised: Flow Chart? Website ELSI Part? </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    10. 11. <ul><li>Ruth Chadwick </li></ul><ul><ul><li>  Paper: on harmonization from an ethical point of view </li></ul></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    11. 12. <ul><li>Elaboration of a table </li></ul><ul><ul><li>25 countries </li></ul></ul><ul><ul><li>National Ethics committees opinions or public policies </li></ul></ul><ul><li>Analyse </li></ul><ul><li>1 . Definitions of biobanks and their scope of application </li></ul><ul><li>2. Informed consent </li></ul><ul><li>3. Confidentiality </li></ul><ul><li>4. Exchange </li></ul><ul><li>5. Public or private sector </li></ul><ul><li>6. Further utilisations </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    12. 13. <ul><li>Establishment of common standards in each ethical focus point, and let country the liberty for the mode of exercise and actions inside of each standard </li></ul><ul><li>How : Chart ? Templates? </li></ul><ul><ul><li>Definition : All ethics bodies consider together samples and data (≠ law) </li></ul></ul><ul><ul><li>Informed consent : obligatory items and let ethics committees validate their expression </li></ul></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    13. 15. <ul><li>Ethics is contemplated as a governance tool. Opinions are built on general ethical values and their objectives are to enlighten the researcher on the ethical issues to be taken into account in biobanking research field </li></ul><ul><li>Other opinions insist on the specific procedures to be respected by researchers and edict kind of guidelines in order to give a code of conduct for professionals </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    14. 16. <ul><li>Institutionnal perspective </li></ul><ul><ul><li>External Governance </li></ul></ul><ul><ul><li>Internal Governance </li></ul></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    15. 17. BBMRI Stakeholders Forum Paris Dec. 2009 Figure 1. Interactions between some societal and biobank-specific governance mechanisms From Building a model framework for the governance of biobanks S Wallace, K Bédard and BM Knoppers, Ethics and Policymaking Core, Centre de recherche en droit public (CRDP), Université de Montréal
    16. 18. BBMRI Stakeholders Forum Paris Dec. 2009 Figure 2. External governance mechanisms
    17. 19. BBMRI Stakeholders Forum Paris Dec. 2009 Figure 3. Internal governance mechanisms
    18. 20. <ul><li>Establish a methodology </li></ul><ul><li>Elaborate a conceptual model </li></ul><ul><li>Implement through the Prototype and incentives (BRIF) </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    19. 21. <ul><li>Map the need : done </li></ul><ul><li>Integrated Governance </li></ul><ul><li>Folow up of the « norms » </li></ul><ul><li>Active public consultations </li></ul>
    20. 22. <ul><li>Make a clear approach of the different models of Biobanks to be included in BBMRI: disease-oriented, population oriented, deceased persons ? Minors ? </li></ul><ul><li>Propose common principles and specific rules </li></ul><ul><li>How to integrate the limits of the production of scientific knowledge ? </li></ul>
    21. 23. <ul><li>A governance “model-based” </li></ul><ul><li>Concept of “person” </li></ul><ul><ul><li>Strong linkage with the persons (clinical BB) </li></ul></ul><ul><ul><li>Below the “person” </li></ul></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    22. 24. <ul><li>TUMOR BANKS </li></ul><ul><li>BODY ELEMENTS REMOVED FROM LIFELESS BODIES (embryo, fetus, corpse). </li></ul><ul><li>Clinical-based biobanks </li></ul><ul><li>Samples initially removed for clinical applications and re-qualified for research uses: re-qualification of the legal framework applying to the uses of the samples, from patients’ rights to “donors’ rights” </li></ul><ul><li>Biobanks unlinked to the legal concept of person </li></ul><ul><ul><li>Beyond the “person”: population-based study. Issues: collective interest, discriminations, circulation of samples and associated data. </li></ul></ul>BBMRI Stakeholders Forum Paris Dec. 2009
    23. 25. <ul><li>Improve communication </li></ul><ul><li>Take into acccount the proposals in the internal governance of BBMRI </li></ul><ul><li>Participate in elaborating an aggreed policy based on agreed principles </li></ul><ul><li>Make effective the participation of patients in the design of the infrastructure </li></ul>BBMRI Stakeholders Forum Paris Dec. 2009

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