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Title: Consent and confidentiality in population genetics and epidemiological research: Ethical aspects of


1
Consent and confidentiality in population
genetics and epidemiological research Ethical
aspects of biobanking in an international
contextIs ethics promoting or preventing
sharing?Bartha Maria KnopppersAnne
Cambon-Thomsen
August 21, 2004
GenomEUtwin ethics educational meeting, Oslo
2
A.I Informed Consent The Framework
  • Legal and Socio- Ethical Context
  • With the assistance of Madelaine Saginur

3
Guiding principles
  • Human dignity
  • Human rights and fundamental freedoms
  • Autonomy
  • Privacy
  • Non-discrimination and non-stigmatization

4
Whats 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.

5
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

6
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

7
A.I Informed Consent The Framework
  • Examples from Europe

8
European Diversity
9
Irreducible Differences
Beer
Wine
10
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_at_cec.e
u.int February 2002, revised October 2002,
present revision under way, will be web
accessible
11
The 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/200
4/genetic/index_en.html 
12
R20 Existing and new biobanks.R 21
Collections of human biological material and
associated data and their useR23 Informed
consentR24 Samples from the deceasedR25
Consent for children and vulnerable individuals

13
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
14
Results the 9 criteria of the French law on
protection of biomedical research participants
15
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.

16
A.I Informed Consent The Framework
  • Examples from North America

17
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)

18
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

19
(a) Public consultation
  • Needed to
  • Achieve transparency
  • Ensure acceptance of the project
  • Address publics concerns
  • Not consent per se however, strong opposition
    could jeopardize project
  • Before and during commencement of the project

20
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.

21
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).

22
(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)

23
Relationship between level of identifiability of
data and waiver
  • In NBACs judgment, where the research uses
    identified or coded samples from previously
    collected specimens, such uses usually are not
    justified without the sources 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

24
(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

25
(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.

26
Core elements of informed consent
  • Prior consent
  • Protection of privacy
  • Duration of conservation
  • Return of results
  • Transfer, access
  • Extension or future research
  • Commercial issues
  • Benefit sharing
  • Written information
  • Aim of the research
  • Methodology
  • Duration of research
  • Risks/benefits
  • Constraints
  • Ethical committee
  • Right to participate or not
  • Right to withdraw

27
Analysis of consent forms Results
28
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

29
A.II Informed Consent The Process
  • Communication by Researchers/Clinicians What, to
    whom, when?

30
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

31
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

32
(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).

33
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.

34
(b) General vs. specificresults
  • 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.

35
(c) General vs. specificresults
  • 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

36
(d) If researcher does notknow 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.

37
If researcher does notknow wishes of subject
  • 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

38
If researcher does notknow wishes of subject
  • 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

39
(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

40
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

41
(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.

42
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 subjects health concerns, and
  • A course of action to ameliorate or treat these
    concerns is readily available
  • NBAC (1999) rec. 14

43
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
    patients responsibility to inform his/her
    relatives Article L1131-1 last paragraph (new)
  • Projet de Loi relatif à la bioéthique (adopté en
    deuxième lecture par lAssemblée Nationale),
    n215, session ordinaire de 2002-2003, 10
    décembre 2003

44
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

45
A.II Informed Consent The Process
  • Points of view of participants/families/
  • ethics committees

46
Ethics as appearing in publications about
geneticsWork 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

47
Overview on reporting elements of management
related to ethical issues in publications
(Essaket, 2004, unpublished)
48
(No Transcript)
49
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

50
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
51
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

52
B.I Use(s) of Biobank Materials
  • Typology of biobanks

53
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

54
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

55
Actors and their context
Commercial Interests
Ethical principles Legal regulation
Scientist(s)
Donors
Medical Applications
Information Cooperation Integrity
56
Ethical issues and points of tension underlined
Development of research Developments over the
years unclear Commercial biobanks Easy access
to them without complications Rights of
priority of researchers / companies
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
57
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!

58
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, 11475-488
59
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
60
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

61
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.

62
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

63
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.

64
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

65
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.

66
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. 72313332, 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,.. 

67
B.I Use(s) of Biobank Materials
  • Confidentiality/ Access/ Secondary Uses

68
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

69
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

70
(a) Confidentiality Level of identifiability of
data
  • Advantages of anonymity
  • Secures absolute confidentiality
  • Eliminates harms associated with secondary uses
    of information

71
Confidentiality Level of identifiability of data
  • Disadvantages of anonymity
  • Sample cannot be linked to the subjects 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

72
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

73
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.

74
(b) Access
  • Generally no disclosure to third parties without
    subjects 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)

75
(c) Secondary uses Waiverof consent
  • WHO (2003) rec. 10
  • Allows for the use of left-over samples when
    anonymized and provided no future identification
    is possible of the samples source
  • HUGO, CIOMS, UNESCO
  • Allow for the use of stored samples and data in
    coded form provided certain conditions are met
  • Continued

76
Secondary uses Waiverof 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

77
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.

78
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

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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.

80
B.II Future of Biobanks
  • International Directions

81
Future of Biobanks International Directions
  • Introduction
  • (a) Benefit-Sharing
  • (b) Databases
  • (c) International Collaboration
  • (d) International Harmonization

82
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

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(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.

84
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.

85
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).

86
(b) Human genomic databases
  • Human genomic databases are global public goods.
  • Statement on Human Genetic Databases, HUGO Ethics
    Committee, December 2002, rec. 1.

87
(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.

88
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.

89
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.

90
(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)

91
Internationalharmonization
  • 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.

92
International harmonization
  • 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.

93
International harmonization
  • 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/

94
B.II Future of Biobanks
  • Modelling and Current Directions

95
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)
96
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/OECDB
    ookShop.storefront/EN/product/932001041E1
  • A working group is preparing rules that have the
    ambition to become international standards (all
    domains specific by domain)

97
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 

98
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)

99
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/stellungnahm
    en/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/in
    dex_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/Lega
    l_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_at_URL_ID188
    2URL_DODO_TOPICURL_SECTION201.html

100
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 

101
In the context of genomics large population
biobanks biobank-omics
Ref CAMBON-THOMSEN A et al. 2003, Comparative
functional genomics, 4  628-634 LObservatoire
de la génétique, 2003, N10 http//www.ircm.qc.ca/
bioethique/obsgenetique Nature Reviews
Genetics, 2004 (in press)
  • 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?

102
Towards Biobank-omics
Donors interest views
Population genetics Genetic epidemiology Genes
involved in diseases process Pharmacogenetics Phar
macogenomics
Organs, cells, DNA
transplant
products
regeneration
DNA-sequences

103
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

104
Actors and their context
Commercial Interests
Ethical principles Legal regulation
Population debate, information bodies
Scientists
Donors
Medical Applications
Information Cooperation Integrity
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