Societal issues: ethics, law and public dialogue

Cancer genetics CEPH’ Paris-

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Cancer in the context of Biobanks .

Societal issues: ethics, law and public dialogue

Anne Cambon-Thomsen,

Directrice de recherche au CNRS

Inserm U 558, « Epidémiologie et analyses en santé publique», Toulouse, France

Ancien Membre du CCNE,

membre GEE (Groupe européen d’éthique)

Cambon-Thomsen, Nat Rev Genet, 2004, 5, 866-873.Rial-Sebbag, Médecine/Sciences, 2006, vol 22.. 8-14


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Equipe: “Génomique, santé, société”Inserm U 558:Epidémiologie et analyses en santé publiqueFaculté de médecine, 37 allées Jules Guesde, Toulouse

A multidisciplinary team on Genomics, health and society


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http://genopole-toulouse.prd.fr/


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Present experiences allow this platform to address the following objectives

• Bring support to members of genomic research community using platform facilities to better identify and address the societal issues in their activities (cycles of thematic seminars, educational sessions, documentation etc.)

• Organize the response to demands of interactions from various publics

• Assist institutional partners in their genomics societal impact analyses (“follow up” and reports on specific subjects)

• Bring an adequate support for the axes “Genetics, science and society” aspects of EU and other international projects

Contact : Anne Cambon – Thomsen, [email protected]://genopole-toulouse.prd.fr/layout.php?page=home2&id=186&lang=fr


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Biobanks: Questions of “sources”, of evolving uses, of societal views on an activity...

• What are the issues?• What are the rules?• Who sets the rules?• How to proceed in practice?


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Context and Definition (s)

“Biobanks” : the biological samples themselves, plus the related databases, allowing a certain level of accessibility, availability and exchange for scientific studies.

Uses of samples and/or uses of data.Medical (diagnostic, follow up, therapeutic), research, development and quality control.Limits not always clear between the different uses.


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Donors Scientist(s)

Actors and their context

Medical Applications

Commercial Interests Ethical principles

Legal regulation

Patients associationsMediaRECs (IRBs)


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The variety of biobanks

The issues extend beyond genetic testing

The context of their constitution/use is variable

They constitute key tools for research and development in genetic testing

Large biobanks are developing, but many smaller exist and are useful.


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What’s at stake?

“…the rapid pace of change has produced two powerful, but conflicting, social reactions. On the one hand, there is very strong public support for breakthroughs promising better medical diagnosis and treatments…; on the other, there are anxieties about increased loss of privacy and the potential for genetic discrimination, as well as about the capacity to regulate genetic science in the public interest.”

Essentially Yours: The Protection of Human Genetic Information in Australia, Australian Law Reform Commission, 2003.

Biobanks are not only for genetic uses but genetic and genomics are developed more and more and can always appear even with samples not collected initially with this aim.


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Ethical issues and points of tension underlined

Rights of persons / groups

Correct information prior consent / old banks

Non commercial use of human body parts

Quality of sample conservation/ management

Optimal & transparent use of samples & data

Development of research

Developments over the years unclear

Commercial biobanks

Easy access to them without complications Rights of priority of researchers / companies


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The status: Persons, Samples and Data

Part of the human bodyInformation about the personInformation 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

• New concept: sample considered as «information carrier » (CDBI)

• When does a sample become a product?• When does a sample become data?


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Ethical framework in France

• Besides the legal rules there are – guidelines of good practices (

http://www.oriamnet.com/Databiotec/databiotec_content.htm : Chart)

And– opinions of the National French Advisory Bioethics

Committee (http://www.ccne-ethique.fr/english/start.htm

• Opinions 25 (1991), 60 (1999), 77 (2003)


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French National Bioethics Committee views on biobanking, 2003

• Complexity of the legal framework in France that (over)regulates in practice biobanking activities in different contexts and does not give so far a clear unified status to collections (this has been taken into account in the revision of bioethics laws)

• Absence of status of the professional biobankers• Difficulty and the limits of the repeated informed

consent in the case of long term use• Necessity of a somewhat extended consent, but with

extensive information on the foreseen activities• Consequent need of stronger security and protection

of individual information


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• Suitability of a contact body for people to follow and get information on what is being done, over time

• Balance to be found between the rights of researchers who have set up collections, on their future use and the openess for optimal exploitation : may vary according to situations but must be clarified

• Notion that, besides the individual rights, there appears a new form of solidarity between groups and between generations, based on the volunteer sharing of samples and information for a “common good” ; this opens to large population biobanks


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• necessary clarification of the public and/or private frame of biobanking and the corresponding guidelines, the present situation being too “foggy”

• necessity for the public power to handle the question of regulation of biobanks in order to make possible to tackle with clarity the legal, economical and international exchange policies instead of the present “jungle”

• the CCNE insists on the importance to fix some limits on the envisaged activities, even with a larger consent

– no “blank consent” that looses its meaning


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• it reminds of the non commercialisation and non availability of elements of the human body

• thus, no “proprietary” right of persons • absolute frontier between scientific/medical use and

judiciary/police use• it affirms the necessity and responsibility of the

public institutions to regulate this activity in a realistic way and to set up regulating bodies able to organise the control of this activity, especially in the context of large national biobanks

• large biobanks needs to be democratically discussed


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Specific questions

• Is there a unified ethical framework in Europe?

• Is large scale population biobanking modifying the picture for all biobanks?

• Is ethics promoting or preventing sharing of bioresources and data?


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The report + 25 Recommendations of the EC Expert Group on the Ethical, Legal and Social Implications of

Genetic TestingConference on Human genetic testing:

what implications? Brussels, May 6-7, 2004

http://europa.eu.int/comm/research/conferences/2004/genetic/index_en.html

Comment at: http://www.ircm.qc.ca/bioethique/obsgenetique/


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R3: genetic exceptionalismR20: Existing and new “biobanks”.

R 21: Collections of human biological material and associated data and their

useR23: Informed consent

R24: Samples from the deceasedR25: Consent for children and

vulnerable individuals


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Recommendations

•Guidelines across the EU to ensure proper use of samples•Member states ensure a competent review committee to be consulted before research •Inventory of existing biobanks and their characteristics•Implement a system to monitor and evaluate their usage•EU following closely activities along this side in Member States and the global context•Contact with OECD “Biological Resource Centres” task force•EU take initiative in co-ordination with other ongoing activities regarding regulatory issues related to collections of human biological material and associated data and their use in research


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What sort of regulations?

• Specific law?• Existing laws + clarification for their application

to biobanks specificities?• Recommendations?

• All models exist• Leave a part to projects themselves with

appropriate supervisionReview in Cambon-Thomsen et al.

http://www.humgen.umontreal.ca/int/GE.cfm


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Practical application of an ethical framework

“Informed” consent : more or less largeExternal committeeData protectionRules of accessRelevance of the degree of identification of the individual sample donor/ right to withdraw


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Different practical situations (1)Source of samples /data

• Use of existing samples /data: Be careful!– obtained in situations of health care (tissues, sera,

cells…)– obtained in situations of “donation” (blood,

sperm…)– obtained in the context of a research project

• Constitution of a new collection of samples and data: Think ahead!


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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– Adult or minor or

other situations– Healthy or disease

affected person

Scientific validity +(?) Re-consent + CommitteeScientific validity + CommitteeScientific validity +/- Committee


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Semantic Interoperability

Knoppers BM, Saginur M. The Babel of genetic data terminology. Nat Biotechnol 2005;23(8):925-7


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DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (2004/23/EC)

Scope: Setting standards for quality and safety for donation,

procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human application

All types of cells/tissues are covered, incl. HSC, cord blood, bone marrow, foetal cell/tissues, embryonic stem cells

Excluded: in vitro research, tissues, organs and cells used for transplantation and for direct autologous grafts, blood and blood products (directives 2001/83/EC, 2000/70/EC, Council Recommendation 98/463/EC, 2002/98/EC))

http://europa.eu.int/comm/health/ph_threats/human_substance/legal_tissues_cells_en.htm


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European Ethical Guidelines

European CommissionResearch Directorate-General

Survey on opinions from National Ethics Committees or similar bodies,

Public debates and national legislation in relation to human biobanks

Directorate E-Life Sciences:Biotechnology, agriculture and food research

Edited by Line Matthiessen [email protected]

Last revision October 2004


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Ongoing debates on:

Informed consent (ind., group, enlarged…..)

Right to receive feed-back information

Conditions for opting-out/withdraw

Use of anonymised specimens

Protection of personal data (is DNA “data”?)

Selling and buying tissues


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International collaboration

“…The full benefits for which the subjects gave their samples will be realized through maximizing collaborative high quality research. Therefore there is an ethical imperative to promote access and exchange of information.”

Data Storage and DNA Banking for Biomedical Research: Technical, Social and Ethical Issues, ESHG, 2001, art. 17.


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International harmonization

“…the changing conditions of genetic research call for the establishment of an international instrument that would enable States to agree on ethical principles, which they would then have to transpose into their legislation.”

Report of the Secretary-General on information and comments received from Governments and relevant international organizations and functional commissions pursuant to Council resolution 2001/39 (11)


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National ethics committees, European group of ethics (EGE), Council of Europe (CDBI), UNESCO

Int Bioethics Committee (IBC), WHO

• Several national ethics committees have or are currently preparing an opinion related to biobanking (France 2003, N° 77; Germany 2004, Switzerland, 2005)

• EGE : – opinion 11 in 1998 on tissue banking; – opinion 19 in 2004 on Cord blood banking

• CDBI of Council of Europe : recommendations about Human sample use in research (2005)

• The IBC (UNESCO): adopted in Oct 2003, an International Declaration on Human Genetic Databases (including samples)

• WHO : working on a set of recommendations (brain storming 2006)


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International initiatives towards harmonization

• BRC (biological resource centre, OECD)• European FP6 Concerted Action: POPULATION

BIOBANK (18 partners, Coordination : Public Health Institute, Oslo) From March 2006 (C Stoltenberg)

• P3G : Public population project in genomics (Canada, BM Knoppers)


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Specific questions

• Is there a unified ethical framework in Europe?

• Is large scale population biobanking modifying the picture?

• Is ethics promoting or preventing sharing of bioresources and data?


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In the context of genomics… large population biobanks : “biobank-omics”

• Scale is changing (Ex: Iceland, Estonia, Sweden, UK…)

– Size– Time– Uses– Throughput

• Are we facing “biobank-omics?”• Has this change in scale and scope impact on

ethical issues and their handling?

Ref: CAMBON-THOMSEN A et al. 2003, Comparative & functional genomics, 4 : 628-634 L’Observatoire de la génétique, 2003, N°10 http://www.ircm.qc.ca/bioethique/obsgenetique


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The UK Biobank Project

Aims to recruit 500 000 individuals aged 45-69 on a voluntary basis trough general practitioners throughout UK

Physical assessment, personal history, lifestyle questionnaire, blood sample

Details on illness, cause of death obtained through NHS medical records; long-term follow-up; National database

Run by Medical Research Council and Wellcome Trust +Budget : € 100 M


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Organs, cells, DNA

transplantregeneration

products DNA-sequences

€

Towards Biobank-omics

Donors´ interests & viewsPopulation geneticsGenetic epidemiologyGenes involved in disease processPharmacogeneticsPharmacogenomics


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When working at population level: Public consultation

“Respecting the principles of reciprocity and accountability requires that research on a given population be based upon open dialogue between the population and the research team(s). A guiding mechanism for population genetic research is prior and ongoing public consultation.”

Statement of Principles on the Ethical Conduct of Human Genetic Research Involving Populations, RMGA, Jan 2003, art. 1.


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Ethical dimensions are challenged by « biobank-omics »

• The scale of studies pushes towards– less individualism and new solidarity, balanced with

more protection of data

Besides the individual rights, there appears a new form of solidarity between groups and between generations, based on the volunteer sharing of samples and information, for a

“common good”

– large biobanks: precious national resource… for whom?– more democratic debate and management


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InformationCooperationIntegrity

Donors Scientists

Actors and their context

Medical Applications

Commercial Interests

Population debate, information bodies

Ethical principles

Legal regulation


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The tendencies

• Large consent, double coded• Possibility of follow up of what is being done with

samples, data• Withdrawal (limits, samples, data)• More sophisticated data security technical tool• Empowerment of research ethics committee• Specification of what will be done “after death”• Information, communication (cancer : area of

considerable interest from the public)


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In conclusion• Human genetics/genomics and cancer : biobanks obliged fields!• Ethical issues in biobanking do matter for international activities,

although ethics remain a national competency• Ethics is different from legal obligations• A number of web resources available for national/international texts • Informed consent is not a magical tool and should be considered as a

factor of dialogue, not only a legal or formal obligation• Importance to follow up with the changes of social attitudes in

considering issues and the appearance of new regulations• Responsibility of researchers and their organisations

– For clarifying the issues /transparency– For education– For position/recommendation– For keeping relevant authorities aware– For stimulation of debate and dialogue


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Thanks for your attention!


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Useful references of web sites• Council of Europe : Convention d’Oviedo

http://www.coe.int/T/E/Legal_Affairs/Legal_co-operation/Bioethics/Texts_and_documents/1Treaties_COE.asp#TopOfPage

• Other international texts or access to texts:– http://europa.eu.int/comm/research/science-society/ethics/

legislation_en.html– ASHG : www.faseb.org/genetics/ashg/policy/pol-25.htm– UNESCO : www.unesco.org/ibc/fr/genome/projet/index.html– WHO : http://www.who.int/genomics/elsi/resources/en/– 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 and population genetics declaration of principles at:

www.rmga.qc.ca (Réseau de médecine génétique appliquée)


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1. Assessing the impact of biobanks CAMBON-THOMSEN A, Nat Genet, 2003, 34, (1): 25 - 262. An empirical survey on biobanking of human genetic material and data in six EU

countries. HIRTZLIN I. et al., Eur J Hum Genet, 2003, 11:475-488 3. Biobanks for genomics and genomics for biobanks. CAMBON-THOMSEN A., DUCOURNAU P.,

GOURRAUD P.A., PONTILLE D. 2003, Comparative and functional genomics, 4 : 628-634

4. The social and ethical issues of post-genomic biobanks. CAMBON-THOMSEN A., Nature Reviews Genetics, 2004, 5, 866-873

5. DNA donor's viewpoint on the consent device. DUCOURNAU P., New Genetics and Society, (accepted 2004)

6. DUGUET AM, THOMAS A RIAL E, DUCHIER J, CAMBON-THOMSEN A., Rev. Médecine légale & droit médical, 2000, 43, N°7.8, 637-641

7. CAMBON-THOMSEN A., Rev. Haut Comité de la Santé Publique, 2001, 34, 55-61 8. DUBREUIL C., DUCHIER J., CAMBON-THOMSEN A. Rev. Prat, 2001, 51, 469-4729. CAMBON-THOMSEN A., Rev. Epidemiol. Santé Publique. 2003, 51: 99.10. CAMBON-THOMSEN A,. RIAL-SEBBAG E., Rev. Epidemiol. Santé Publique. 2003, 51 : 101-110.11. RIAL-SEBBAG E., Rev. Epidemiol. Santé Publique. 2003, 51: 111-120 .12. CAMBON-THOMSEN A. RIAL-SEBBAG E. DUCHIER J., Rev. Epidemiol. Santé Pub. 2003, 51: 121-26. 13. CAMBON-THOMSEN A L’Observatoire de la génétique, 2003, N°Avril 2003, 2004 Mars, Août ,

Novembre 2004 http://www.ircm.qc.ca/bioethique/obsgenetique/14. CAMBON-THOMSEN A Les cahiers du Comité Consultatif National d’Ethique, 2004, 38: 39-42 et

2004, N° de Nov. 200415. DUCOURNAU P. Sciences Sociales et Santé, in press 2005

Publications by members of A. Cambon-Thomsen team on informed consent & biobanks ethical/legal/social issues (2000 – 2004)

Societal issues: ethics, law and public dialogue

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