The European perspective on ethics in biobanking and genetics

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

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?

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

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

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

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

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

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 ….

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

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

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.

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

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

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

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

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)

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.

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

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

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

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

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

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

Ways of funding Biobanking

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

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)

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.

Typology issued from the survey: Six main types of human biobanks

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)

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)

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.

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

The European perspective on ethics in biobanking and genetics

by Pammy98 on Jul 26, 2010

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The European perspective on ethics in biobanking and genetics — Presentation Transcript