jasper bovenberg

BBMRI:Ethical, Social and Legal Issues

Antoni van Leeuwenhoek (Delft, The Netherlands, 1632-1723)

Antoni van Leeuwenhoek Founding Father of BBMRI

• Autodidact scientist• Invented his own

microscopes• Investigated his own

samples:– blood, – hair– sperm

• Imaging..

He made images of his own samples:

Annotation, Shipping, Sharing Samples and Data

• He annotated his samples

• He shipped his annotated samples from the Netherlands to the Royal Society in Londen

• He shared his findings with European Scientists

BBMRI

• Royal Society stored his annotated samples

• His samples can still be analyzed today

• He started a European Biobanking and Biomolecular Resources Research Infrastructure

Ethical Legal and Social issues?

• No Ethical, Legal or Social Issues

• No Consultations, No Focus Groups, No Guidelines, No Stakeholder Forums,

• So why have ELSI today?• AvL provided answer

Van Leeuwenhoek on ELSI

• “… the world, being wicked and stupid enough, could use the knowledge of Natural History to bring ruin upon herself, and more and more could disrupt in dissoluteness.

September 11, 2009

Why ELSI for BBMRI?• Fear of abuse by ‘wicked and stupid world’• Society needs biobanks because biobanks can contribute greatly to

the health of the European population. But biobanks also need society:

– in the form of generalized support for biobank projects;– financial resources;– cooperation of patients and healthy individuals– trust generated towards biobanks (Cambon-Thomsen, 2004).

• In democratic societies, science, and even more so “big science” (such as BBMRI), cannot succeed without strong social and political support, social understanding and the resulting social legitimacy (Gottweis, 2005a).

September 11, 2009

Remit of BBMRIRemit of BBMRI

To develop an infrastructure which is “properly embedded into European ethical, legal and

societal frameworks”

FP7, Grant Agreement Nr. 212111

WP 6WP 6

• WP leader: A. Cambon-Thomsen, E. Rial- WP leader: A. Cambon-Thomsen, E. Rial- Sebbag, InsermSebbag, Inserm

• Ethical Issues and Gender (Ruth Ethical Issues and Gender (Ruth Chadwick)Chadwick)

• Social Issues (Herbert Gottweis)Social Issues (Herbert Gottweis)• Legal Issues (Jasper Bovenberg)Legal Issues (Jasper Bovenberg)


September 11, 2009

Ethical IssuesEthical Issues

• “Can ethics be harmonized?”

• How should ‘harmonisation’ in ethics be interpreted?

• How does it differ from ‘standardisation’?

• To what extent is ethics in this area dependent on social context?

• What are the acceptable margins of deviation from standards in relation to BBMRI?

• What are the challenges in making BBMRI congruent with ‘European values’?

• To what extent are ethical traditions in tension with new developments in this area?


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• Harmonisation – consistent, universal, global system of concepts and/or principles; is this possible and/or desirable in ethics?

• Standardisation – less burdensome – standards often established without requiring full-blown harmonisation.

• Standardisation alone, whilst practical, is not sufficient – the ongoing process of harmonisation must continue.


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• Necessary Conditions model: Philosophical approach; identifies cross-cultural ethical features; produces abstract, descriptive principles. Success is limited - prone to cultural bias.

• Human Rights model: Political/legal approach; functional but minimal. Abstract nature fails to account for multitude of perspectives; more akin to standardisation.

• Cultural Dialogue approach: Requires comprehensive, continual, inter-cultural discussion; aims to discover parallel norms and produce a concrete, thick, global ethic.


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Main areas of focus for the BBMRI:• Opportunity to consent – common standard helps ensure equality of

concern for each voice.• Access and feedback – of less concern? Differing standards may be

acceptable?• Privacy – complex area; maintenance of dialogue essential.• For both BBMRI and Ethics: Harmonisation is ongoing process driven by

the interplay of many different voices, including those less often heard, in relation to the ‘text’ of the standards in question. Results must be fit for purpose: dialogue must be focused upon problem at hand.


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Social Issues

Post-Modern Patchwork of Publics

We need to carefully study the contemporary patchwork of publics by using appropriate research tools, in particular focus groups, panels, and other qualitative methods

And integrate quantitative and qualitative approaches

The few existing focus group and panel group studies indicate a much more nuanced public perception of biobank topics

Important implications for science communication

Focus Groups(A, NL)

Eurobarometer

European attitudes towards Biobanks

Social IssuesEmerging Themes From Austrian-Dutch Focus Group Research

(Life Science Governance Institute, Vienna, Centre for Society and Genomics, Nijmegen and Athena Institute, Free University, Amsterdam)

Knowledge Gap: Broad Lack of Knowledge and Understanding of Biobanks Absence of Context Awareness Information – Attitude link: Positive Correlation Pessimistic View of Data/Information Handling by Medical Researchers:

Patient Rights Awareness Partially Bioethics Myth Non-Patients Often Uneasy About Medical Research Anonymity More Important than Consent Issues: Consent More an Issue for

Scientists and Bioethicists than for Lay Publics Diversity of Publics Crucial Opposition Towards Broad Consent Forms Collaboration Between Biobanks Seen as “Obvious” Thing to Do European Collaboration Seen In Positive Light Call for Regulations, European Regulations for European Projects Biobank (Science) Communication: Unresolved Issue

YoutubeTwitter involved

Facebook

Wikipedia

BBMRI Website

Links Advertisements

BlogsTwitter

Some Ideas for Communicating AND Interacting with European Publics

Legal IssuesLegal Issues

• Consent, Data Protection, Feedback, Access, IP etc.• Issues complicated by broad approach of BBMRI:

• Population biobanks; AND• Clinical biobanks; AND• Biological resources

• Issues complicated by cross border dimension of BBMRI:• Can you ship samples from Belgium to Greece?• Can you transmit data from Finland to Spain?


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• Current situation in EU is legal patch-work• Top down EU harmonisation problematic and time

consuming• Alternative solution to build on existing expertise• Develop legal platform using WIKI to unearth existing

legal documents


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WIKI provides BBMRI with practical tool to:• Upload time-tested documents and templates;• Discuss, review and amend;• Edit, validate and update; Benefit from ‘wisdom of

participants and stakeholders’• Engage stakeholders, including participants;


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What you can do for BBMRI: • Go www.legalpathways.eu.e-dot.nl

• Create an account• Try and Use Templates

• Contribute Your Own Expertise/Document• [email protected]


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http://www.legalpathways.eu.e-dot.nl/

Next stepsNext steps• Work on gender issues has started (R Chadwick)

• Next steps:

– Open WIKI+ legal platform; + hSERN (www.hsern.eu)

– Analyse ELSI part of BBMRI questionnaires

– Set up ELSI part of prototype

– Analyse Eurobarometer (biobank part, delayed to 2010 )

– Publish new contributions in addition to those available• so far several chapters/ articles written on secondary uses, exchanges, harmonisation

• to write: overview based on D6.1 = ethical framework of biobanks in European countries

– Incentives (working group with GEN2PHEN on bioresource impact measurement that

should use the prototype as pilot study)


September 11, 2009

jasper bovenberg

Technology