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The European perspective on ethics in biobanking and genetics

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12-13/09/2002 A. Cambon- ESF Workshop Biobanks, Uppsala. 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 : [email protected] An empirical survey on biobanking in human genetics in six EU countries The European perspective on ethics in biobanking & genetics
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Page 1: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

A. Cambon-Thomsenand 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 : [email protected]

An empirical survey on biobanking in human genetics in six EU countries

The European perspective on ethics in biobanking & genetics

Page 2: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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?

Page 3: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 4: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 5: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 6: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

General Ethical principles

• Respect of human dignity, beneficence, non-maleficence, justice: – Autonomy– Privacy– Physical and individual integrity – Human body inalienable and unavailable – Equality– Freedom

Page 7: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 8: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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 ….

Page 9: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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 : http://www.humgen.umontreal.ca– Guidelines, model consent at : www.rmga.qc.ca

Page 10: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 11: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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.

Page 12: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 13: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 14: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 15: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 16: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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)

Page 17: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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.

Page 18: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 19: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 20: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 21: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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

Page 22: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

Status France Germany Netherlands Portugal Spain United Kingdom

Laboratories withinhospitals or healthinstitutes (public or

private non-for profit)

52.1% 80 % yes 9% 76.1% 58%

Research anduniversity laboratories

10.5 % 20 % yes 82 % 16.7% 17 %

Firms (biotech orpharmaceutical

companies)

13.4 % 0% 0% 0% 0% 0%

Centres for studiesand conservation of

eggs and sperm

7.5% 0% 0% 0% 0% 0%

Blood banks 3% 0% 0% 0% 0% 8%

Patient association 4.5% 0% 0% 0% 0% 0%

Forensic institutions 4.5 % 0% 0% 9% 7.2% 17%

Others 4.5 % 0% 0% 0% 0% 0%

Total Number 67 10 5 11 42 12

Genetic material banking is an activity concerning all kinds of research or health care organisations

Page 23: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

Purpose France Germany Netherlands Portugal Spain UnitedKingdom

Total

Diagnosis 46 yes yes 7 32 5 >90Familial studies 32 yes yes 9 3 6 >50Polymorphism

characterisation29 yes yes 4 8 5 >46

Epidemiologicalstudies

25 yes yes 6 4 4 >39

Functional studies 29 yes yes 3 0 3 >35Clinical follow-up 26 yes yes 4 0 3 >33Genetic mapping 17 yes yes 3 2 5 >27

Elaboration ofsubstances of

industrial interest

9 ND ND 1 0 1 11

Drug development 8 ND ND 1 0 1 10Pharmacogenomics 8 ND ND 0 0 2 10

Gene therapy 8 ND ND 0 1 0 9Other 0 ND ND 0 0 1 1

How to read? 46 for France means that among the returned questionnaires the use of collections for diagnosis has been evoked 46 times

Uses of collections by country and order of importance

Page 24: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

Fundingsources(number of banks percountry)

France Germany Netherlands Portugal Spain United Kingdom Total

Global budget ofthe organisation

56 9 5 9 38 5 122

Funding byco-operativeagreement

10 9 0 1 5 1 26

Grants 27 9 0 0 1 3 40Sales 6 0 0 0 0 0 6Unanswered 0 0 0 0 0 4 4Total (doubleentries allowed)

99 27 5 10 44 13 198

Ways of funding Biobanking

Page 25: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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 

Page 26: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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)

Page 27: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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.

Page 28: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

Type 1:Smallpubliccollections

Type 2:Largepubliccollections

Type 3:Databases

Type 4:Privatecollections

Type 5:Privatenon forprofit

Type 6:Established bystatus1

Status ofinstitute

Public

Private fornon-profitPrivate forprofit

Size ofcollections

Small

MediumLarge

Age ofcollections

< 5 years

Between 5and 10 years> 10 years

Purposes ofcollections

Health

ResearchHealth andresearchForensicOthers

Openness YesNo

Specificbudget

Yes

NoCost Bad known

Well knownPricing Fee for

serviceGift andexchangeNoexchange

Legend Mostfrequent

Lessfrequent

1 For instance : forensic institute, blood transfusion centre, centre of studies and conservation of sperm…

Typology issued from the survey:

Six main types of human biobanks

Page 29: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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)

Page 30: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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)

Page 31: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

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.

Page 32: The European perspective on ethics in biobanking and genetics

12-13/09/2002 A. Cambon-Thomsen ESF Workshop Biobanks, Uppsala.

ConclusionsConclusions

• 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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