Emmanuelle Rial

A. Cambon-Thomsen and E. Rial-SebbagBBMRI WP6

WP leader Anne Cambon-Thomsen (INSERM, Toulouse), Assist. Emmanuelle Rial-Sebbag (INSERM)

Co-leaders/Participants 1.Legal pathways Institute for Bio-Law (LP),

NL, Jasper Bovenberg (jurist)2.Center for Economics and Social Aspects of

Genomics, Cardiff University, (CU), UK, Ruth Chadwick (philosopher)

3.Life Science Governance Institute, (LSGI), Herbert Gottweis (political scientist)

BBMRI Stakeholders Forum Paris Dec. 2009 2

To design an ethical, legal and social framework for the establishment of BBMRI◦ agreed, ◦ harmonized ◦ implementable

To propose corresponding strategies and scenarios ◦ operational concept ◦ contractual agreements.

3BBMRI Stakeholders Forum Paris

Dec. 2009

D6.1: Report on ethics related policies for biobanks and biomolecular resources in countries of BBMRI (mo 9) Inserm - CU

D6.2: Design of legal WIKI+ platform (mo 8) – LP - Inserm

D6.3: Launch of legal WIKI+ platform and mobilising BBMRI stakeholders (mo 14) - LP - Inserm

D6.4: Background document on harmonization from an ethical point of view (mo 12) CU - Inserm

D6.5: Background document on how BBMRI should address its social dimension (mo 17) LGSI - Inserm


Dec. 2009

D6.6: Schema of a conceptual model of governance applicable to a pan-European infrastructure for ELSI issues (mo 20) Inserm-all

D6.7: Uploading and validation of documents of BBMRI Members and Partners on platform (mo 20) - LP - Inserm

D6.8: Strategic plan and scenarios for BBMRI interactions with various publics (mo 22) LSGI - Inserm

D6.9: Flow chart of an operational integrated ELSI governance model (mo 27) Inserm-all

D6.10: Overall report and Recommendations for BBMRI ELSI, including educational proposals (mo 28) Inserm - all

D6.11: Implementation and monitoring of gender issue plan (mo 28) - CU - LSGI

D6.12: Final report (mo 29) Inserm - all


Dec. 2009

WP 6 is a « box » of competencies (Ethics, law and social issues)

National experts network

Documents and tools (e.i. Legal WikiPlateform)


BBMRI Community

Building the BBMRI Community

Agreed principles

Principles in « action »

Communication formalised: Flow Chart? Website ELSI Part?


Ruth Chadwick◦ Paper: on harmonization from an ethical point of view


Dec. 2009

Elaboration of a table◦25 countries◦National Ethics committees opinions or public policies

Analyse1. Definitions of biobanks and their scope of application 2. Informed consent3. Confidentiality4. Exchange5. Public or private sector6. Further utilisations


Dec. 2009

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

How : Chart? Templates? ◦ Definition : All ethics bodies consider together

samples and data (≠ law)◦ Informed consent : obligatory items and let ethics

committees validate their expression


Dec. 2009

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

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


Institutionnal perspective

◦External Governance

◦Internal Governance


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 biobanksS Wallace, K Bédard and BM Knoppers, Ethics and Policymaking Core, Centre de recherche en droit public (CRDP), Université de Montréal

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Figure 2. External governance mechanisms

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Figure 3. Internal governance mechanisms

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Establish a methodology

Elaborate a conceptual model

Implement through the Prototype and incentives (BRIF)


Map the need : done

Integrated Governance

Folow up of the « norms »

Active public consultations

Make a clear approach of the different models of Biobanks to be included in BBMRI: disease-oriented, population oriented, deceased persons ? Minors ?

Propose common principles and specific rules

How to integrate the limits of the production of scientific knowledge ?

A governance “model-based”Concept of “person”◦Strong linkage with the persons (clinical BB)

◦Below the “person”


TUMOR BANKSBODY ELEMENTS REMOVED FROM LIFELESS BODIES (embryo, fetus, corpse).

Clinical-based biobanksSamples 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”

Biobanks unlinked to the legal concept of

personBeyond the “person”: population-based study. Issues: collective interest, discriminations, circulation of samples and associated data.


Improve communication

Take into acccount the proposals in the internal governance of BBMRI

Participate in elaborating an aggreed policy based on agreed principles

Make effective the participation of patients in the design of the infrastructure


Emmanuelle Rial

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