Societal issues: ethics, law and public dialogue

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

Equipe: “Génomique, santé, société” Inserm U 558: Epidémiologie et analyses en santé publique Faculté de médecine, 37 allées Jules Guesde, Toulouse A multidisciplinary team on Genomics, health and society

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

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_address]
http://genopole-toulouse.prd.fr/layout.php?page=home2&id=186&lang=fr

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?

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.

Actors and their context Donors Scientist(s) Medical Applications Commercial Interests Ethical principles Legal regulation Patients associations Media RECs (IRBs)

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.

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.

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

The status: Persons, Samples and Data
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
New concept: sample considered as «information carrier » (CDBI)
When does a sample become a product?
When does a sample become data?

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)

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

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

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

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

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?

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

R3: genetic exceptionalism R20: Existing and new “biobanks”. R 21: Collections of human biological material and associated data and their use R23: Informed consent R24: Samples from the deceased R25: Consent for children and vulnerable individuals

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

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 supervision
Review in Cambon-Thomsen et al. http://www.humgen.umontreal.ca/int/GE.cfm

Practical application of an ethical framework “ Informed” consent : more or less large External committee Data protection Rules of access Relevance of the degree of identification of the individual sample donor/ right to withdraw

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!

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 + Committee Scientific validity + Committee Scientific validity +/- Committee

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

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

European Ethical Guidelines European Commission Research 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 Line-Gertrud.Matthiessen-Guyader@cec.eu.int Last revision October 2004

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

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.

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)

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)

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)

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?

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

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

Towards Biobank-omics Organs, cells, DNA transplant regeneration products DNA-sequences € Donors´ interests & views Population genetics Genetic epidemiology Genes involved in disease process Pharmacogenetics Pharmacogenomics

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 .

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

Actors and their context Information Cooperation Integrity Donors Scientists Medical Applications Commercial Interests Population debate, information bodies Ethical principles Legal regulation

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)

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

Thanks for your attention!

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)

Assessing the impact of biobanks CAMBON-THOMSEN A, Nat Genet , 2003, 34, (1): 25 - 26
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
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
The social and ethical issues of post-genomic biobanks . CAMBON-THOMSEN A., Nature Reviews Genetics, 2004 , 5, 866-873
DNA donor's viewpoint on the consent device. DUCOURNAU P., New Genetics and Society , (accepted 2004)
DUGUET AM, THOMAS A RIAL E, DUCHIER J, CAMBON-THOMSEN A., Rev. Médecine légale & droit médical , 2000, 43, N°7.8, 637-641
CAMBON-THOMSEN A., Rev. Haut Comité de la Santé Publique , 2001, 34, 55-61
DUBREUIL C., DUCHIER J., CAMBON-THOMSEN A. Rev. Prat , 2001, 51, 469-472
CAMBON-THOMSEN A., Rev. Epidemiol. Santé Publique . 2003, 51: 99.
CAMBON-THOMSEN A,. RIAL-SEBBAG E ., Rev. Epidemiol. Santé Publique . 2003, 51 : 101-110.
RIAL-SEBBAG E ., Rev. Epidemiol. Santé Publique . 2003, 51: 111-120 .
CAMBON-THOMSEN A. RIAL-SEBBAG E. DUCHIER J., Rev. Epidemiol. Santé Pub . 2003, 51: 121-26.
CAMBON-THOMSEN A L’Observatoire de la génétique , 2003, N°Avril 2003, 2004 Mars, Août , Novembre 2004 http://www.ircm.qc.ca/bioethique/obsgenetique/
CAMBON-THOMSEN A Les cahiers du Comité Consultatif National d’Ethique , 2004, 38: 39-42 et 2004, N° de Nov. 2004
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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