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The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
The European perspective on ethics in biobanking and genetics
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The European perspective on ethics in biobanking and genetics

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  • 1. An empirical survey on biobanking in human genetics in six EU countries A. Cambon-Thomsen and the EUROGENBANK consortium* co-ordinated by JC Galloux2
        • 1. Inserm U 558, Toulouse, France
        • 2. University Paris 2 and University of Versailles Saint Quentin, France
    • * Lisboa, P: P Lobato de Faria, Central Lancashire, UK : R Chadwick , ZADI - Bonn, D:F Begemann, CPRO-DLO – Wageningen, NL: B Visser , Siena, I: CM Mazzoni, Nordic Gene Bank – Alnarp, S: E Thörn, BRG - Paris, F: A Sontot and Inra - Grenoble, F: M Trommetter, Lünenburg, D: J Simon , Torino: A Piazza, Helsinki, FI: A Sajantila, INIA – Lisboa / EAN - Oeiras, P: E Bettencourt, Barcelona : J Bertranpetit
    • BIOTECH EU Contract  : N° BIO4-CT98-0570
        • Contact : cambon@cict.fr
    The European perspective on ethics in biobanking & genetics
  • 2. New results New questions
    • Acquired results
    • Genetic component of a disease elucidated
    • Genetic component of common diseases
    • Population genetics new tools
    • New polymorphisms
    • Genetic material and DNA collections
    • Problems posed
    • Which prediction? Why? How to use it?
    • Place of genetics in health programmes?
    • Ethical and organisational aspects
    • Which markers to choose?
    • Ethical aspects and how to manage them?
  • 3. Basic remarks
    • History of genetics
    • Genetic diversity
      • Its study opens on the past and on the future
    • Characteristics of (human) genome
      • Common human patrimonium (cf UNESCO declaration)
      • Unique characteristics of the individual
    • Component of the human body which can be considered at the same time as the most private and the most shared one
  • 4. Genetic material and genetic information
    • Part of the human body
    • Information about the person
    • Information about the family
    • Information about a group of individuals (population)
    • All rules and recommendations tend to pull in one of these two directions :
      • Part of a person
      • Information about a person or a group
  • 5. Context of the survey
    • Biobanks have existed for long but their use in genetic studies evolves and increases
    • Several levels of considerations in biobanking :
      • technical issues
      • ethics and legal issues
      • economical and strategic issues
      • institutional and political issues
    • Lots of work available on ethics, principles, recommendations
    • Less data on practices, actual situations in Europe: A European EU funded project with an empirical survey : EUROGENBANK 1999 - 200;1Co-ordinator : JC Galloux
  • 6. General Ethical principles
    • Respect of human dignity, beneficence, non-maleficence, justice:
      • Autonomy
      • Privacy
      • Physical and individual integrity
      • Human body inalienable and unavailable
      • Equality
      • Freedom
  • 7. Translation of ethical basic principles into actions
    • Ethical principles for protection of individuals participating to research and collections :
      • Informed consent (not that simple!)
      • Non commercial use of human body elements…….
      • Confidentiality and protection of private life
      • Limitation of genetic testing to medical use or research with ethical committee agreement
    • Some countries have specific bioethics laws
  • 8. International texts and guidelines
        • Nuremberg Code (1947).
        • Helsinki declaration (1964, 2000).
        • Directives from WHO . (Manille, 1981).
        • Recommendations HUGO (1996, 1998, 2000).
        • Convention of Council of Europe ( Oviedo, 1997).
        • UNESCO declaration ( december 1997).
        • Recommendations ESHG (2001) .
        • Current US texts (BAC) in USA ….
  • 9. Useful references of web sites
    • Council of Europe :
      • www.coe.fr/cm/ta/rec/1990/90/3.html
      • www.coe.fr/fr/txtjur/164fr.htm
    • Other international texts or access to texts:
      • ASHG : www.faseb.org/genetics/ashg/policy/pol-25.htm
      • UNESCO : www.unesco.org/ibc/fr/genome/projet/index.html
      • WHO 1998 : www.who.int/ncd/hgn/hgnethic.htm
      • HUGO : www.gene.ucl.ac.uk/hugo/conduct.htm “ “ “ “ /sampling.html
      • HGDP : ww.stanford.edu/group/morrinst/hgdp/protocol/html
      • National Bioethics Advisory Commission : www.nih.gov/index.html : “The use of human biological materials in research : Ethical issues and policy guidance”
      • OECD report on Biological Resource Centers http://www.oecd.org/
      • ESHG : www.eshg.org (EuroGapp)
      • Canadian site Humgen : h ttp://www.humgen.umontreal.ca
      • Guidelines, model consent at : www.rmga.qc.ca
  • 10. Specific points related to genetics in population (1)
      • Access to healthy population, not always in relation with medical purposes or in a medical research context
      • Search for large sample size at population level
      • Individual informed consent versus group consent
      • Work at international level, with various regulatory texts in the various countries
      • Different cultural contexts
      • Kind of results to be returned
  • 11. Specific points related to genetics in population (2)
      • Sample and data banks
      • Exchanges between research groups of samples and data
      • Interest of industrial groups in collected population samples
      • Work done over years on the same samples not always known precisely at the time of sampling.
  • 12. Samples and data
    • Biological samples (different kinds)
    • Information attached to the sample a priori (personal, medical)
    • Information attached to the sample a posteriori (Ex : resulting from a lab test)
    • Information non attached to the individual samples (Frequencies of markers in a population…)
    • Progressive non planned collection
    • Planned organized collection +/- open
  • 13. Different practical situations (1) Source of samples /data
    • Use of existing samples /data :
      • obtained in situations of health care
      • obtained in situations of “donation” (blood, sperm…)
      • obtained in the context of a research project
    • Constitution of a new collection of samples and data
  • 14. Different practical situations (2) Characteristics of samples/data
    • Degree of possible identification of persons through samples
      • Identifying
      • Traceable or identifiable or coded
      • Anonymised
      • Anonymous
    • Type of persons concerned
      • families or non related individuals
      • major or minor or other situations
      • healthy or disease affected
  • 15. Criteria of informed consent content (French Huriet-Sérusclat Law, 20/12/1988 ). ( Other laws or proposals)
    • Written information given
    • Aim of the research
    • Methodology
    • Duration of research
    • Risks
    • Constraints
    • Ethical committee
    • Right to participate or not
    • Right to resign at any time
    • Prior consent (88,94)
    • Protection of privacy (78, 94)
    • Duration of conservation
    • Return of results
    • Exchanges, access
    • Extension or future research
    • Commercial issues
    • Benefit sharing policy
  • 16. General difficulties
    • Consent for genetic studies has specific features which should be taken into account at an international level (guidelines, model consent at : www.rmga.qc.ca)
    • There is no international consensus about how to manage and organise collections of human material for genetic studies (it starts : reports and recommendations at : www.eshg.org)
  • 17. Aims of the survey
    • The aims of the European Research Project EUROGENBANK for its human biobanking empirical part were :
      • 1) to acquire information on the organisational and economical aspects, in a variety of biobanks
      • 2) to make a typology of the different situations actually encountered in several European countries
      • 3) to investigate the way ethical implications were dealt with in various contexts.
  • 18. Methodology (1)
    • The steps were :
    • 1) to make a general overview in each of the countries involved
        • on scientific, organisational and economical issues
        • on existing ethical and legal regulatory texts
    • 2) to investigate through an empirical survey a number of banks meeting certain criteria
        • through questionnaires
        • through interviews
    • 3) to make a comparison allowing a typology integrating various aspects
  • 19. Methodology (2)
    • Use general overviews to establish criteria for choosing targets for empirical survey
    • Design of questionnaire and interview structure
    • Data capture and definition of variables
    • Statistical analysis and analysis of contents
    • Report by country
    • Comparison : common trends, specific features
    • Typology
    • Recommendations
  • 20. Sampling of structures involved in human genetic biobanking performed for EUROGENBANK in 6 EU countries
    • Data obtained through :
    • a general overview in 9 EU countries
    • an empirical survey in 6 EU countries
    • (UK, France, Germany, Netherlands, Portugal, Spain)
    • Total: 147 structures with human biobanking activity explored by questionnaire and interviews
    Public or private non for profit Private for profit
  • 21. Questionnaire structure and items
    • 60 questions in 10 sections 200 variables
      • Information on institution
      • Description of collections
      • Mode of acquisition of collections
      • Work done on samples and its cost
      • Characteristics of storage
      • Exchanges and distribution
      • Dissemination of information
      • Computerisation and data management
      • Difficulties encountered
      • Present and future organisation
  • 22. Genetic material banking is an activity concerning all kinds of research or health care organisations
  • 23. Uses of collections by country and order of importance How to read? 46 for France means that among the returned questionnaires the use of collections for diagnosis has been evoked 46 times
  • 24. Ways of funding Biobanking
  • 25. Ethical issues and points of tension underlined
    • rights of persons (autonomy, confidentiality, protection of private life)
    • correct information prior consent and old banks
    • non commercial use of human body parts
    • maximum quality of sample conservation & management
    • optimal and transparent use of samples / data for quick progress of knowledge
    • rights of researchers
    • developments over the years unclear
    • development of commercial products samples
    • easy access to them without complications
    • rights of priority of primary researchers and companies interests 
  • 26. Major trends and common features
    • Almost all interviewed structures belong to the public sector or private for non-profit sector
    • Public structures of research or/and healthcare have a key role for banking activity
    • Banking activity is increasing in all the countries because few samples are discarded and genetic activity is growing
    • The size of collections is variable, with often lot of small collections and few very large ones
    • Purposes of collections are often research or research and healthcare ; mostly diseases motivate the constitution of collections
    • Samples are usually provided free of charges as gift or exchanges
    • Very diverse level of precision in consent forms (+++1990)
  • 27. Major trends and common features
    • Specific budget is rarely allocated to biobanking activity
    • Costs of storage are not often evaluated ; they are small compared to sample manipulation
    • Good practice guidelines are generally followed and quality controls performed but quality procedures are not always clearly explained
    • Associated data are often computerised ; mostly identity information is linked and samples are identified or traceable
    • Biobankers are generally against centralisation of samples but favourable to a centralisation of biobank data
    • A European legal and ethical harmonisation could facilitate the growing international collaborations in genetic banking ; but questions remains about its feasibility.
  • 28. Typology issued from the survey: Six main types of human biobanks
  • 29. Proposals drawn from results of Eurogenbank project (1)
    • Official recognition and identification of biobanking activity
    • Financial sustainability
    • Guidelines for quality of collections
    • Need of education to biobanking
    • Simplification and harmonisation of administrative procedures
    • Harmonisation of import/export rules within EU
    • Harmonisation of framework for consent forms, further use, gene ownership
    • Develop a European view on benefit sharing (HUGO’s considerations)
  • 30. Proposals drawn from results of Eurogenbank project (2)
    • Clarify who (or which body) is the interlocutor for biobanking at the EU commission level
    • Support to organisation of aspects of biobanking by actors at national or European level
    • Only back up at “central” level (duplication)
    • Organisation of platforms of exchanges
    • Start projects about the organisation of a centralisation of data about samples not of samples themselves (databases interconnected)
  • 31. Discussion
    • Biobanking is a lively, growing and strategic activity in Europe, practised in numerous sites for a long time
    • Its rather loose organisation, when at small scale, is not adapted to forthcoming large scale projects
    • Professional biobankers are appearing
    • Budget identification and sustainability goes parallel with less flexibility
    • Challenge to face in building up standards:
      • to work out an optimal organisation in respect of ethical principles,
      • to allow the continuation and use of the large variety of biobanks that have proven to be very useful for many years.
  • 32. Conclusions
    • Genetic material collections and population studies are one of the aspects of human genetics generating issues of general relevance in human genetics
    • Relations between different aspects of human genetics
    • Symbolic dimension of human genetics in society
    • Increased accuracy of issues and difficulties at the international scale
    • Importance of communication and debate
    • Question of education of « the public » to genetics but also of education of future geneticists to ethical issues management

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