Biobank

Consent and confidentiality in population genetics and epidemiological research: Ethical aspects of biobanking in an international context Is ethics promoting or preventing sharing? Bartha Maria Knopppers Anne Cambon-Thomsen August 21, 2004 GenomEUtwin ethics educational meeting, Oslo

A.I Informed Consent: The Framework Legal and Socio- Ethical Context With the assistance of Madelaine Saginur

Guiding principles
Human dignity
Human rights and fundamental freedoms
Autonomy
Privacy
Non-discrimination and non-stigmatization

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.

Universal Declaration on the Human Genome and Human Rights, UNESCO, 1997.
Need to address ethical issues of genetics (preamble)
Genome – common heritage of humanity (art. 1)
Respect individuals’ uniqueness and diversity (art. 2)
Non-commodification of the human genome (art. 4)
Benefit-sharing (art. 12)
Freedom of research (art. 12)
Solidarity (art. 17)
International co-operation (arts. 18, 19)
The Universal Declaration is a starting point; it is now up to the States to put the Declaration into practice…

International texts and guidelines
Nuremberg Code (1947).
Helsinki Declaration (1964 - 2002).
Directives from WHO . (Manille, 1981-).
Statements HUGO (1996 -).
UNESCO Declaration ( December 1997 - ).
Convention of Council of Europe (Oviedo, 1997).
Recommendations ESHG ( 2001 -) .
US texts (NBAC) in USA ( 1999 )
Declaration of principles for research in genetics and in population genetics ( Quebec, 2000 - 2002 )
French and German National ethics committees working in 2003-04 on a statement on biobanks

A.I Informed Consent: The Framework Examples from Europe

European Diversity Large Small Coffee Bread White Dark

Wine Beer Irreducible Differences

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 February 2002, revised October 2002, present revision under way, will be web accessible

The 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

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

Analysis of practices through consent forms used in genetic research in France
Obtaining a sample of consent forms and the attached information sheet used in genetic research ( 151 included in the study used before 1998)
Analysis of their content according to three views:
law
research
person being a research subject
Comments and proposals
From de la Dorie, 1998 and Cambon-Thomsen & de la Dorie, 1999

Results : the 9 criteria of the French law on protection of biomedical research participants

Conclusion
Consents :
Often do not completely fulfill the law requirements
Some issues are poorly addressed: outcome of sample, feed back of results, opinion of a minor, exchanges, non profit or for profit use
Law requirements must not hide true ethical issues and do not prevent debates on sensitive issues
There is an heterogeneity between research ethics committees even within one country
When becoming objects of research human beings remain free subjects.

A.I Informed Consent: The Framework Examples from North America

Historical position
No individual, specific consent  no research
Yes individual, specific consent  yes research
Not accounted for:
- relevance of genetic data beyond the individual
- effect on the family/community
- public consultation? (a)
- long-term relevance of genetic data
- waiver of consent? (b)
- broad/blanket consent? (c)
- re-consent? (d)

Tri-Council Policy Statement – Ethical Conduct for Research Involving Humans , Canada, 1998
Broadening possibilities of consent
- provision of a number of options on consent form:
a) use of the material only in the present study;
b) use restricted to the condition; or
c) other clearly specified uses
- specifying arrangements to maintain contact with the subject regarding future uses

(a) Public consultation
Needed to
Achieve transparency
Ensure acceptance of the project
Address public’s concerns
Not consent per se ; however, strong opposition could jeopardize project
Before and during commencement of the project

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. 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 .

Public consultation
research on identifiable community  community consultation
minimize harm for the community.
substantial opposition within the community  investigators should not conduct the study.
support of community  still obtain individual consent in the usual manner
E-2.079 Safeguards in the Use of DNA Databanks in Genomic Research, American Medical Association, June 2002, art. (2).

(b) Waiver of consent
Consent requirements can be waived if:
the research involves no more than minimal risk to the subjects,
the waiver will not adversely affect the rights and welfare of the subjects,
the research could not practicably be carried out without the waiver, and
whenever appropriate, the subjects will be provided with additional pertinent information after participation
NBAC (1999) p.66; See also: AMA (2003); TCPS (1998)

Relationship between level of identifiability of data and waiver
In NBAC’s judgment, where the research uses identified or coded samples from previously collected specimens, such uses usually are not justified without the source’s consent, because the risks to sources and others may be more than minimal. However, the use of unidentified or unlinked samples for research could be justified in some cases if other appropriate protections were in place, despite the lack of informed consent.”
NBAC (1999) p.71

(c) Broad/blanket consent
“ When human biological materials are collected, whether in a research or clinical setting, it is appropriate to ask subjects for their consent to future use of their samples, even when such uses are at the time unknown.”
NBAC (1999) p.63

(d) Re-consent
Consent is a continuing process and must be reconfirmed for instance in the case of significant changes to the research protocol, to the conditions of banking…
RMGA (2003) art. 3.

Core elements of informed consent
Written information
Aim of the research
Methodology
Duration of research
Risks/benefits
Constraints
Ethical committee
Right to participate or not
Right to withdraw
Prior consent
Protection of privacy
Duration of conservation
Return of results
Transfer, access
Extension or future research
Commercial issues
Benefit sharing

Analysis of consent forms: Results

Towards convergence?
Items of relevance
Clarification of how those items are addressed in a given cultural context
Work at multidisciplinary level to construct information packages and consent forms
But, do not overestimate the written document: interaction is important
Consent as a process not a procedure
Take advantage of current technology

A.II Informed Consent: The Process Communication by Researchers/Clinicians: What, to whom, when?

A.II Informed Consent: The Process
Right to know
Right not to know
General vs. specific results
If researcher does not know wishes of subject
Danger of providing information
Issues specifically applicable to biological relatives

Return of results: A balancing act
Right to know
Duty to warn this is the secret to make the bullets line up. You will soon be written in white. How sneaky!
Biological relatives: data potentially of medical interest to them
Right not to know
Danger of providing information that is very preliminary/ without counselling/ where no treatment available
Biological relatives: privacy of donor of genetic sample

(a) Right to know
“ No one should be denied access to his own genetic data…”
UNESCO (2003) art. 13.
“ Personally identifiable information … should be subject to adequate subject access rights”
WHO (2003) rec. 18.
“… after the completion of the study, subjects will be informed of the finding of the research in general, and individual subjects will be informed of any finding that relates to their particular health status”
CIOMS (2002) Guideline 5(7).

Right not to know
“… the person concerned has the right to decide whether or not to be informed of the results”
UNESCO (2003) art. 10.
“ Adequate account must be taken of the privacy interest that individuals have in not knowing information about themselves.”
WHO (2003) rec. 16.

(b) General vs. specific results
General:
Results should be made public
It is reasonable to expect that researchers should communicate with the population and the relevant governmental authorities regarding results that are pertinent to the improvement of health and/or the prevention of disease
RMGA (2003) 6.

(c) General vs. specific results
Specific:
“ Should the participant wish to be recontacted to obtain the results, he should remain in contact with the researcher in charge (i.e. updating of coordinates)”
Results should be communicated to the participant when:
they are scientifically valid,
They have significant implications for the health of the participant, and
prevention or treatment is available
RMGA (2000) II.4, IV.3

(d) If researcher does not know wishes of subject
“… in circumstances where there is no evidence of what an individual would want to know, it is not possible to [ask] them if they would wish to know, for to do so is to indicate that there is, indeed, something to know, and thereby any possible harm will have been caused.”
WHO (2003) section 5.3.

“ Before any unsolicited approach is made, the following factors must be considered:
The availability of a cure or therapy;
The severity of the condition and the likelihood of onset;
The nature of the genetic disease;
continued…

The genetic nature of the disease, i.e. – that it might have significant implications for blood relatives;
The nature of any genetic testing that will be required;
The question of how the individual might be affected if subjected to unwarranted information, and whether the individual has expressed any views on receiving information of this kind.”
WHO (2003) rec. 16

(e) Danger of providing information…
outside of clinical setting
not evaluated in context of the full medical record
not evaluated in context of knowledge of medication or other treatment
the significance of the observations might not be clear
research staff not be in a position to interpret the implications.
information but not interpretation, counseling or support.
“ For these reasons, UK Biobank will in general not provide health information to participants”
UK Biobank Ethics and Governance Framework, Version 1.0, 2003

Danger of providing information…
“… Researchers should exercise caution in the communication and interpretation of their results due to the complexity of genetic information and its personal, familial, and social impact.”
RMGA (2003) art. 6

(f) Return of results to biological relatives - International
immediate and clear benefit to individuals
avert or minimize significant harm to the relevant individuals
WHO (2003) s.4.3.
VS
Investigators should not disclose results of diagnostic genetic tests to relatives of subjects without the subjects’ consent
CIOMS (2002) commentary on guideline 18.

Return of results to biological relatives - National
Conditions for disclosure to biological relatives: Canada
non-disclosure could lead to serious and foreseeable harm
The risk of harm can be avoided through prevention or can be controlled through scientifically proven treatment
RMGA (2000) III.3
United States
The finding are scientifically valid and confirmed
The findings have significant implications for the subject’s health concerns, and
A course of action to ameliorate or treat these concerns is readily available
NBAC (1999) rec. 14

Return of results to biological relatives - National
Conditions for disclosure to biological relatives, continued:
France
Medical practitioner has an obligation to inform the patient of a) the importance to disclose relevant information to family members if a cure or preventive treatment exists, b) that it is the patient’s responsibility to inform his/her relatives Article L1131-1 last paragraph (new)
Projet de Loi relatif à la bioéthique (adopté en deuxième lecture par l’Assemblée Nationale), n°215, session ordinaire de 2002-2003, 10 décembre 2003

Conclusion
More explicit balancing of rights and of advantages and disadvantages taking place both at the international and the national level
Distinction more clearly drawn between refusal of access to third parties such as insurers or employers (to come) and the legitimate needs (in prescribed circumstances) for communication to biological relatives
Still significant variation in approaches taken, both at international and at national levels

A.II Informed Consent: The Process Points of view of participants/families/ ethics committees

Ethics as appearing in publications about genetics Work of Soumia Essaket, Health Ethics Diploma, Toulouse, 2004
Aim: Are ethical issues and their management mentioned in publications about human genetics research in relation with the legal framework?
Methods: a corpus of 168 articles on human genetics in populations (with French participation) analysed for mention or not of
Informed consent
Ethics committee approval
Acknowledgements and thanks for participants help
In 2 periods (73 articles, 1987 – 91 = before practical implementation of the French law on protection of persons in biomedical research and 95 articles published in year 2000 = after

Overview on reporting elements of management related to ethical issues in publications (Essaket, 2004, unpublished) 168 94 74 Total 95 30 65 Period after that law 73 64 9 Period before application of law on protection of persons in biomedical research Total Mention absent Mention present

Informed consent as seen by research participants (based on Ducournau, accepted in New Genetics and Society, 2004)
Aim : a typology of attitudes towards informed consent
Method : a qualitative analysis based on 50 interviews of participants in a research case/control study in genetic epidemiology of cardiovascular diseases involving a biobank
Results :
a gradient of various attitudes from support and trust to negative perception and distrust
Influence of previous experiences of relations with the medical world

Critical appreciation of consent by participants are distributed at the margins of a continuum of logic of action Non-criticising comments. Procedure as "a ritual of trust" "Hybrid" attitude made of (1) attention paid to the individual conditions of participation and (2)collaboration in favour of a cause. Criticisms Procedure is felt as in contradiction with the recognition of the generous participation act Gift attitude towards medical progress, collectivity . Criticisms. Procedure felt as an obstacle to the construction of trust Strategic conduct, coupled with a mistrust toward medical profession or medical institutions Adapted from Ducournau, 2004

Conclusion on informed consent
It is indispensible
Who or what does it protect?
It has to be as « prospective » as possible in terms of long term research: giving options is a good option!
It is an evolving process
It is not a magical tool
Its limits must be recognised
Its main feature is that it plays its role when it is an instrument of dialogue

B.I Use(s) of Biobank Materials Typology of biobanks

General Context
Biobanks have existed for long but their use (in genetic studies) evolves and increases
Several levels of considerations in biobanking
technical issues (70s)
ethics and legal issues (80s)
economical and strategic issues (90s)
institutional and political issues (2000...)
Lots of work available on ethics, principles, recommendations
Less data on practices, actual situations in Europe

Persons, 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…)
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 »

Actors and their context Information Cooperation Integrity Donors Scientist(s) Medical Applications Commercial Interests Ethical principles Legal regulation

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

Different practical situations 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!

The variety of biobanks in Europe Some information from an EU funded project : Eurogenbank
The aims 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.
Consortium of 15 teams in 9 countries
BIOTECH EU Contract : N° BIO4-CT98-0570
Hirtzlin et al. Eur J Hum Genet, 2003, 11:475-488

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
Work done on samples and its cost
Characteristics of storage
Ownership, exchanges and distribution
Dissemination of information
Computerisation and data management
Difficulties encountered
Present and future organisation

Some features
Key role of public structures of research or/and healthcare
Biobanking activity is increasing in all the countries
The size of collections is variable , with often lot of small collections and few very large ones
Specific budget is rarely allocated to biobanking activity in non dedicated structures
Very diverse level of precision in consent forms (+++1990)
A European legal and ethical harmonisation could facilitate the growing international collaborations in biobanking; but questions remains about its feasibility.

Typology issued from the survey: Six main types of human biobanks
Relevant criteria:
Public – Private status of institution
Size of collection
Age of collection and date of start
Purposes
Level of openess
Specific budget identified
Costs and tariffs

Current situation
Biobanking is an ancient but lively, growing and strategic activity in Europe
Its rather loose organisation, when at small scale, is not adapted to forthcoming large scale projects
Professional “biobankers” are appearing : need education
Budget identification and sustainability are important and 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.

Specific points related to genetics in population using collections of samples and data
Access to healthy population, not always in relation with medical purposes or in a medical research context : do not harm is not enough …
Search for large sample size at population level
Heterogeneity of consent/assent : Individual informed, enlarged consent, opt out, group consent…
Work that will be done over years on the same samples not always known precisely at the time of sampling
Work at international level , with various regulatory texts in the various countries; Different cultural contexts , values and views
Kind of results to be returned (general, individual, how)
Sample and data banks ownership
Transfer of samples and data between research groups (level of protection, control on use?)
Interest of industrial groups in collected population samples and benefit sharing

A Problem: population genetics done in Europe
Indian ethical bodies and research council are complaining that genetic research has been conducted in Europe on Indian - possibly illiterate tribal- population, possibly without asking for proper informed consent and also with no benefit for Indian researchers or Indian population (benefit sharing)
EU funds used as well as NIH. This is the first case in which the EU is blamed. More cases are known until now of US origin.
Criticisms are :
No Indian institution or scientists are mentioned
No mention is made of the necessary research clearances.

A controversial case; not unique?
The Genetic Heritage of the Earliest Settlers Persists Both in Indian Tribal and Caste Populations T. Kivisild et al.
Institutions of authors in Estonia, UK, Germany, Russia, Kuweit, Stanford
Am. J. Hum. Genet. 72:313–332, 2003
“ After informed consent was obtained, 180 blood samples were collected from healthy and maternally unrelated volunteers belonging to Chenchu and Koya tribes from Andhra Pradesh,….. »

B.I Use(s) of Biobank Materials Confidentiality/ Access/ Secondary Uses

Different practical situations 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
Adults or minors or other situations
healthy or disease affected

Use(s) of Biobank Materials
(a) Confidentiality
advantages of anonymity
disadvantages of anonymity
recommendations
(b) Access
(c) Secondary Uses
waiver of consent
blanket consent
Conclusion

(a) Confidentiality: Level of identifiability of data
Advantages of anonymity:
Secures absolute confidentiality
Eliminates harms associated with secondary uses of information

Confidentiality: Level of identifiability of data
Disadvantages of anonymity:
Sample cannot be linked to the subject’s medical record, greatly reducing its value over time
If research uncovers information from which the subject would benefit, it will not be possible to convey it to the subject or his/her physician
If the subject withdraws from the study, it is not possible to destroy the sample

Confidentiality
Use the most secure level of identifiability of data which allows the research to take place.
UNESCO (2003) art. 14(e)
WMA (2002) art. 24
CE (2002) art. 9
AMA (2002) art. 4
RMGA (2003) rec. 4

Confidentiality
“ Using either the identified information model or the permanent anonymization model for controlling the flow of information to the researcher is problematic and would require special justification. The choice between double-coding and single coding is perhaps somewhat less clear-cut.”
Consortium on Pharmacogenetics (2002) Research, F.

(b) Access
Generally: no disclosure to third parties without subject’s consent
UNESCO (2003) art. 14(b)
Barriers to access by third parties (insurers, employers, educational institutions) can be achieved in two ways:
Directly – proscribed (e.g. WHO (2003) s.6.1)
Indirectly – limiting purpose (CE (1997) art. 12)

(c) Secondary uses: Waiver of consent
WHO (2003) rec. 10
Allows for the use of left-over samples when anonymized and provided no future identification is possible of the sample’s source
HUGO, CIOMS, UNESCO
Allow for the use of stored samples and data in coded form provided certain conditions are met:
Continued…

Secondary uses: Waiver of consent
Conditions:
HUGO (1998): For samples leftover from routine medical care
General notification of such a policy
Patient has not objected
CIOMS (2002):
Minimal risk
Secondary use expected to yield significant benefits
Secondary use could not realistically or reasonably take place were consent requirements to be imposed
UNESCO (2003):
Consent cannot be obtained
In accordance with national law
Proper ethical oversight

Secondary uses: Blanket consent
Participants should be informed of the possibility of future uses of data, beyond the limits of the present consent, and should be provided with an opportunity to withhold consent to such uses
WHO (2003) rec. 6(8).
Informed consent may include blanket consent
HUGO (2002) rec. 4(a).
A reasonable policy is to secure a degree of flexibility by allowing the subject to consent to a range of related studies over time
Consortium on Pharmacogenetics (2002) Research, B.

Conclusion
Trends:
(1) allowing for the possibility of deviating from the traditional principle of explicit re-consent for future use of samples collected for a specific research purpose as long as the privacy/confidentiality of the research sample is ensured;
automatic anonymization of samples as the expedient solution to the ethical and legal quandaries is being re-examined and coding is emerging as the preferred option in many situations;
Continued…

Conclusion
(3) wholesale prohibition of general/blanket consent to future unspecified uses of both research samples and left-over samples from medical care without a specific consent is increasingly nuanced; and growing recognition of the ethical validity of broad or general consent to genetic research or banking especially for longitudinal studies.

B.II Future of Biobanks International Directions

Future of Biobanks – International Directions
Introduction
(a) Benefit-Sharing
(b) Databases
(c) International Collaboration
(d) International Harmonization

Universal Declaration on the Human Genome and Human Rights, UNESCO, 1997.
Genome – common heritage of humanity
Respect individuals’ uniqueness and diversity
Non-commodification of the human genome
Benefit-sharing
Freedom of research
Solidarity
International co-operation

(a) Benefit-sharing
All humanity share in, and have access to, the benefits of genetic research.
Benefits not be limited to those individuals who participated in such research.
Prior discussion with groups or communities on the issue of benefit-sharing
Even in the absence of profits, immediate health benefits as determined by community needs could be provided.
At a minimum, all research participants should receive information about general research outcomes.
Profit-making entities dedicate a percentage of their annual net profit to healthcare infrastructure and/or to humanitarian efforts
HUGO Ethics Committee, Statement on Benefit-Sharing, 2000.

Benefit-sharing
“ In all circumstances, the provision of research materials, including DNA samples, should be on the undertaking that some kind of benefit will ultimately be returned, either to the individual from who [sic] the materials were taken, or to the general class of person to which that individual belongs.”
Genetic Databases: Assessing the benefits and the impact on human & patient rights, WHO, 2003, rec. 19.

Benefit-sharing
“… benefits resulting from the use of human genetic data … should be shared with society as a whole and the international community.”
International Declaration on Human Genetic Data, UNESCO, 2003, art. 19(a).

(b) Human genomic databases
Human genomic databases are global public goods.
Statement on Human Genetic Databases, HUGO Ethics Committee, December 2002, rec. 1.

(c) 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 collaboration
foster international medical and scientific cooperation and ensure fair access
foster the international dissemination of scientific knowledge and scientific and cultural cooperation
establish cooperative relationships
International Declaration on Human Genetic Data, UNESCO, 2003, art. 18.
See also: European Commission, The 25 Recommendations on the ethical, legal and social implications of genetic testing, 2004, rec. 21.

International collaboration
Recommendation: That
The European Commission promotes opportunities for dialogue between stakeholders to support exchange of experience throughout Europe on issues of sample and data use for research, at the individual, family and population level.
The European Commission funds multidisciplinary research into the ethical, legal and social issues related to informed consent procedures for human genetic research and other relevant areas essential for any evolving research in genetics.
The 25 recommendations on the ethical, legal and social implications of genetic testing, European Commission, 2003, rec. 23.

(d) 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)

International harmonization
“ This report endorses the universalisability of human rights, and it is considered that its recommendations equally enjoy this quality.”
“… whether funding comes from a public, private or voluntary source, all research should be subject to the same ethical scrutiny.”
Genetic Databases: Assessing the benefits and the impact on human & patient rights, WHO, 2003 ss. 2.3, 7.2.

“ The challenge to international research ethics is to apply universal ethical principles to biomedical research in a multicultural world with a multiplicity of health-care systems and considerable variation in standards of health care.”
International Ethical Guidelines for Biomedical Research involving Human Subjects, CIOMS, 2002, Introduction.

P3G Objectives:
Connect the leading public population genomics projects
Provide necessary coordination, harmonization and standardization so the combined results be used for the advancement of science around the world
Develop common understanding of the socio-ethical and legal issues
Foster a deeper understanding of the relative contribution of genetic and non-genetic determinants to health and disease
Transfer this knowledge to the international community so as to optimize benefits for public health
http://www.p3gconsortium.org/

B.II Future of Biobanks Modelling and Current Directions

Policy statements of E S H G Public & Professional Policy Committee (PPPC)
ESHG. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective.
Background document and recommendations of the Eur Soc Hum Genet. 2001
http://www.eshg.org/PPPC.htm
Eur J Hum Genet, 2003, 11, 906-908
Eurogapp EU project (Co-ordinator : S Aymé)

OECD task force
OECD. Biological Resource Centres: Underpinning the Future of Life. Sciences and Biotechnology ;
OECD Code 932001041E1. 2001.
http://oecdpublications.gfi-nb.com/cgi-bin/OECDBookShop.storefront/EN/product/932001041E1
A working group is preparing rules that have the ambition to become international standards (all domains + specific by domain)

Definition OECD 1999 Tokyo workshop on BRC, 1999 Biological Ressources Centres
« Biological Ressources Centres are an essential part of the infrastructure underpinning biotechnology. They consist of service providers and repositories of the living cells, genomes of organisms, and information related to heredity and the functions of biological systems. BRC contains collections of culturable organisms (e.g. micro-organisms, plant, animal and human cells), replicable parts of these (e.g. genomes, plasmids, viruses, cDNAs), viable but not yet culturable organisms, cells and tissues, as well as databases containing molecular, physiological and structural information relevant to these collections and related bioinformatics »

A specific professional society for biorepositories
ISBER: International Society for Biological and Environmental Repositories http://www.isber.org
Meeting for first time in Europe this year (Perugia, Italy, October 17 – 20, 2004)

National ethics committees, European group of ethics (EGE), Council of Europe (CDBI), UNESCO Int Bioethics Committee (IBC)
Several national ethics committees have or are currently preparing an opinion related to biobanking (France 2003, N° 77, http://www.ccne-ethique.fr/english/start.htm; Germany 2004, http://www.ethikrat.org/stellungnahmen/stellungnahmen.html)
EGE : opinion 11 in 1998 on tissue banking; opinion 19 in 2004 on Cord blood banking http://europa.eu.int/comm/european_group_ethics/index_en.htm
CDBI of Council of Europe preparing in 2004 an additional protocol to the Convention on Human rights and biomedicine about Human sample use in research http://www.coe.int/T/E/Legal_affairs/Legal_co-operation/Bioethics/
The IBC (UNESCO) has adopted in Oct 2003, an International Declaration on Human Genetic Databases (including samples)
http://portal.unesco.org/shs/en/ev.php@URL_ID=1882&URL_DO=DO_TOPIC&URL_SECTION=201.html

Assessing the use of biobanks CAMBON-THOMSEN A, Nat Genet , 2003, 34, (1): 25 - 26
BIF : Biobank Impact Factor. Why?
Need of long term recognition
Need of sharing resources outside specialised circles
Need of connecting the use of biobanks with the results and impact of research
Need to find and justify resources for biobanking
Presently no quantitative parameter
How?
Standardise way of citation of biobanks used, in publication
Tracking by ISI
Choose parameters very carefully
Over time BIF would become a more rational measure of the impact than « reputation »

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 ; Nature Reviews Genetics , 2004 (in press)

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

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

Biobank

by Pammy98 on Jul 26, 2010

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Biobank — Presentation Transcript