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Ethical aspects of biobanks and progress status of the Genome Project in Latvia

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Title: Ethical aspects of biobanks and progress status of the Genome Project in Latvia


1
Ethical aspects of biobanks and progress status
of the Genome Project in Latvia
  • Valdis Pirags
  • Seminar for the Research Ethics Committees of the
    Baltic countries
  • Skolas iela 3, Riga
  • May 9-10, 2008

2
Background
  • Biomedical research utilising stored human
    biological materials is a powerful tool to
    improve human health and healthcare systems
  • The primary intention of research undertaken on
    human biological materials is to advance
    knowledge so that patients in general may benefit

Recommendation on research on human biological
materials, Council of Europe, 2005
3
Controversy biomedical research vs medical
practice
In biomedical research the primary intention is
to advance knowledge so that patients in general
may benefit
In medical practice the sole intention is to
benefit the individual patient
Knowledge of general benefit may emerge from the
clinical experience gained
An individual research participant may or may not
benefit directly
Convention on Human Rights and Biomedicine, on
Biomedical Research, draft additional Protocol,
2003
4
Ethical problem
  • How to make knowledge of general benefit gained
    from the biomedical research useful for every
    individual patient?

Solution
Population based health and genome databases
Risks
Social or psychological risks to the gene donors
5
1.Introduction to the population based Genome
Projects
6
Development and transformation of the Latvian
Genome Project
  1. Initiative group for the human genome research in
    Latvia created (1999). First proposal of the
    Latvian Genome Project submitted to the
    government
  2. Collaboration programme Genetic Studies of
    Latvian Population, Application for Diagnosis and
    Prevention of Human Pathology funded by the
    Latvian Council of Science (since 2001)
  3. Pilot project Genome Database of the Latvian
    Population funded directly by the government
    (2003)
  4. National Research Programme Study of the main
    pathologies threatening the life expectancy and
    quality of the Latvian population supervised by
    the Ministry of Education and Science (2006-2009)

7
Collaboration project funded by the Latvian
Science Council Latvijas populacijas genofonda
izpete saistiba ar cilveka patologiju
  • Research on genetic factors regulating metabolism
    and homeostasis (Janis Klovinš)
  • Molecular Genetics of the Coronary Heart Disease
    (Normunds Licis)
  • The role of pharmacogenetics in treatment of
    oncologic diseases (Aija Line)
  • The influence of genetic factors on development
    of hereditary breast and ovary cancer (Laima
    Tihomirova)
  • Molecular genetic charasteristics of the Latvian
    population (Viesturs Baumanis)
  • Diagnostics of mutations influencing the
    pathogenesis of monogenic diseases (Inta
    Vasiljeva)
  • Elaboration of molecular genetic methods and
    their use in genetic research Services of the
    Latvian Genome Centre (Elmars Grens)

8
Genome Database of the Latvian Population the
main project
  • November 1, 2006. The Cabinet of Ministers
    authorized the Latvian Biomedical Research and
    Study Centre to create the Genome Database of the
    Latvian Population.
  • March 22, 2007. The Central Medical Ethics
    Committee approved the protocols and documents
    used by the Genome Database of the Latvian
    Population
  • September 20, 2007. The Latvian Genome Centre
    started to collect the samples and data in
    collaboration with the general practitioners and
    largest hospitals

9
Latvian Genome Database Recruitment Update 5,732
(May 2008)
10
National Research Programme in Medicine
(2006-2009)
  • Multidisciplinary research consortium on the main
    pathologies threatening the life expectancy and
    the quality of life of the Latvian Population
  • The recruitment target for the years 2008-2009 is
    4,000 randomly selected and carefully phenotyped
    individuals from all parts of Latvia

11
Proposed population biobank projects in Europe
2000-2006
Goals 1.Understand the interaction between
genes, environment, lifestyle and
disease 2.Create the engine for the transfer of
this knowledge to health care systems
DeCODE Genetics in Iceland
EGP in Estonia
LGP in Latvia
UK Biobank in UK
12
Promoting Harmonisation of Epidemiological
Biobanks in Europe (PHOEBE) 6FP (2007-8)
The Norwegian Institute of Public Health
(coordinator)
National Public Health Institute, Finland
Karolinska Institutet, Sweden
Aim a collaborative research network that will
identify and explore key issues that will help to
ensure that Europe makes best use of its rich
array of population-based biobanks and
longitudinal cohort studies
McGill University, Canada
UK Biobank
University of Tartu, Estonia
University of Leicester, UK
Charles University, Czech Rep.
University of Bristol, UK
Imperial College of Science, Technology and
Medicine, UK
INSERM U558, France
13
Genome banks and networks in Europe (2008)
  • Public Health Genomics (PHGEN) http//www.phgen.nr
    w.de/typo3/index.php
  • The German National Genome Research
    Network http//www.ngfn.de/englisch/index.htm
  • UK Biobank http//www.ukbiobank.ac.uk/
  • Molecular Phenotyping to Accelerate Genomic
    Epidemiology MolPAGE http//molpage.org/pubs.asp
  • European Network of Genomic and Genetic
    Epidemiology (ENGAGE) http//www.euengage.org/scie
    nce.html
  • Biobanks for health in Norway http//www.fhi.no/ew
    ay/default0.asp?e0pid225
  • Genome Database of the Latvian Population
  • http//biomed.lu.lv/gene/
  • Estonian Genome Project Foundation http//www.geen
    ivaramu.ee/index.php?langengshowmain
  • GenomeEUtwin http//www.genomeutwin.org/
  • Public Population Projects in Genomics
    (P3G) http//www.p3gconsortium.org/
  • P3G Observatory http//www.p3gobservatory.org

14
Public Population Projects in Genomics (P3G)
Members are international, national or regional
not-for-profit organizations that are conducting,
or will be conducting a large population genomics
project such as a biobank or a large-scale cohort
study (Ngt10 000 samples)
  • ALSPAC (UK) CARTaGENE (Canada) Centre for
    Integrated Genomic Medical Research (United
    Kingdom) Danubian Biobank Foundation
    (Germany) Estonian Genome Project
    (Estonia) Generation Scotland (UK) GenomEUtwin
    (Finland) INMEGEN (Mexico) INSERM (France) King
    Saud bin Abdulaziz, University for Health
    Sciences (Saudi Arabia) KORA-gen
    (Germany) LifeGene (Sweden)
  • LifeLines Cohort (Netherlands) National Cancer
    Institute (USA) National Heart, Lung and Blood
    Institute (USA) Norwegian Institute of Public
    Health (Norway) NUgene Project (USA) Ontario
    Cohort Consortium (Canada) Singapore Tissue
    Network (Singapore) Taiwan Biobank Institute of
    Biomedical Sciences, Academia Sinica (Taiwan) UK
    BioBank (UK) Western Australian Genome Health
    Project (Australia)

15
UK Biobank Recruitment Update 114,217 (9pm
Thursday 8 May 2008)
  • UK Biobank is a major UK medical research
    initiative, and a registered charity in its own
    right, with the aim of improving the prevention,
    diagnosis and treatment of a wide range of
    serious and life-threatening illnesses
    including
  • cancer,
  • heart diseases,
  • diabetes,
  • arthritis
  • forms of dementia
  • UK Biobank is now recruiting 500,000 people aged
    40-69 from across the country to take part in
    this project
  • UK Biobank Ethics and Governance Council

16
Estonian Genome Project Recruitment Update
18,141 (May 2008)
17
Legislation specific to Biobanks
  • Act on Biobanks , Iceland/Government, Ministry of
    Health and Social Security (Iceland, 2000).
  • Government regulation on a Health Sector Database
    , Iceland/Government - Ministry of Health and
    Social Security (Iceland, 2000).
  • Human Genes Research Act , Estonia/Government
    (Estonia, 2000).
  • Human Genome Research Law , Latvia/Government
    (Latvia, 2002).
  • Act Relating to Biobanks , Norway/Government
    (Norway, 2003).
  • Biobanks in Medical Care Act , Sweden/Government
    (Sweden, 2003).
  • Human Tissue Act 2004 , United Kingdom/Government
    (United Kingdom, 2004).

18
Selected guidelines and reports
  • Australian Law Reform Commission (2003)
    Essentially Yours The Protection of Human
    Genetic Information in Australia - contains 144
    recommandations of the commission
  • WHO's European Partnership on Patients' Rights
    and Citizens' Empowerment (2004) Genetic
    databases assessing the benefits and the impact
    on human and patient rights - the ethical,
    social and legal issues that surround the
    creation and operation of databases containing
    human genetic material
  • Fonds de la recherche en santé du Québec (2006)
    Governance Framework for Data Banks and Biobanks
    Used for Health Research the final report by
    the Advisory Group on the collection, processing,
    utilization, storage and management of data banks
    and biobanks for health research purposes
  • the Bioethics Advisory Committee, Singapore
    (2007) Personal Information in Biomedical
    Research - a report discussing the need to use
    personal information in biomedical research and
    makes recommendations aimed at establishing
    principles for data protection and confidentiality

19
Comparison of Latvian and Estonian Genome projects
Latvian Genome Project Estonian Genome Project
Main aim To create a national system of genomic and health information storage and data processing To establish a Gene Bank, that contains health and genetic data on the people of Estonia
Legal basis The Human Genes Research Act passed by parliament in June 2002, amended in June 2003 The Human Genes Research Act passed by parliament in December 2000
Owner-ship The genome database is operated by the state scientific institution authorized by the government and controlled by the Council of Genome Database The gene bank belongs to the Estonian Genome Project Foundation
20
Initial comparison of Latvian and Estonian Genome
projects 2006
Latvian Genome Project (similarities to the UK Biobank) Estonian Genome Project (similarities to the DeCODE Genetics)
Funding The establishment of the genome database is funded by the government The establishment of the Gene Bank is funded by investors and funds
Profit Main processor of the genome database may not have profit from utilization of coded tissue samples, DNA descriptions and health descriptions Founders of the Gene Bank may have profit from scientific and applied discoveries
Coding and decoding Coding is performed by the main processor under supervision of the State Data Inspection. Decoding is performed by the State Population Genome Register Coding and decoding can be performed by the EGPF only under supervision of the Data Protection Inspectorate
21
2. Ethical aspects of population biobanks -
what is the best way of data protection? -
ownership of biological materials and data
22
Long tradition of data collection Latvian
Folklore Repository has more than 1 500 000
entries, circa 400 000 folk songs, including 4
000 naughty dainas
23
More than 5 000 DNA samples and associated data
(including potentially sensitive data) are filed
in the Latvian Genome Data Base in 2008
24
Contains diagnosis completed according to the
International Classification of Diseases.
Information is based on documentation in medical
records
25
Contains 45 questions including information on
ethnicity, life stile, family, anthropometry,
disease status (more detailed on cancer,
cardiovascular and endocrine diseases)
26
No. 34,343 received from R.Berzinš living
in Džukste
Identified data in the Latvian Folklore
Repository
27
Identifiability of biological materials and
associated data
  • Biological materials and associated data should
    be anonymised as far as appropriate to the
    research activities concerned.
  • Identifiable materials and data should not be
    utilised if there are less intrusive means to
    reach similar results.
  • Where there are identifiers, it is necessary to
    have a well-developed framework of protections to
    ensure that the risks to sources of human
    biological materials and data are minimised.
  • However, it must be kept in mind that in some
    cases, unlinked anonymisation might not be
    appropriate in the interests of the persons
    concerned or for scientific reasons.

Recommendation on research on human biological
materials, Council of Europe, 2005
28
Identifiability of biological materials and
associated data
  • Any use of biological materials and associated
    data in an identified, coded, or linked
    anonymised form should be justified by the
    researcher
  • Ethics committees should ask researchers
    proposing to use unlinked anonymised biological
    materials to justify this choice in terms of the
    inevitable consequence that it means that there
    will be no possibility of giving health-related
    feedback resulting from the research to persons
    concerned

Recommendation on research on human biological
materials, Council of Europe, 2005
29
Organisation for Economic Cooperation and
Development
DRAFT GUIDELINES FOR HUMAN BIOBANKS AND GENETIC
RESEARCH DATABASES 2008
30
The aim of the Guidelines
  • to provide guidance on the establishment,
    governance, management and use of Human Biobanks
    and Genetic Research Databases (HBGRDs) used for
    purposes of genetic research.

31
1. HBGRDs Generally
  • The objective of a HBGRD should be to foster
    research within legal norms and ethical
    principles.
  • ...
  • The HBGRD should consider and minimise risks to
    individuals, their families and potentially
    identifiable populations or groups whose
    specimens and data are included in the HBGRD and
    used for research.

32
2. Establishment of HBGRDs
  • The purpose(s), both current and future, of the
    HBGRD should be clearly formulated, and
    communicated as early and as widely as possible,
    especially to potential participants and
    potential users.
  • In the establishment of the HBGRD, the initiators
    should carry out consultations with stakeholders
    and the general public.
  • The HBGRD should develop a business plan,
    including a financial model, that it intends to
    adopt over its lifespan in order to ensure its
    sustainability.
  • The HBGRD should be explicit and transparent
    about the nature and source of its
    financing/funding.

33
3. Governance, Management, and Oversight
  • The HBGRD should be governed by the principles of
    transparency and accountability.
  • The initiators of the HBGRD should clearly
    formulate the governance structure and management
    responsibilities applicable to the HBGRD and
    should make available information to
    participants, stakeholders and the general
    public.
  • The governance structure should ensure that the
    rights and well-being of the participant prevail
    over the research interests of the initiators and
    users of the HBGRD.
  • Within its governance structure, the HBGRD should
    have a mechanism to review applications for
    access to the human biological materials and/or
    data

34
4. Terms of Participation
  • HBGRDs should obtain prior, free and informed
    consent from each participant. Where applicable,
    HBGRDs should provide for obtaining consent or
    authorisation from the appropriate substitute
    decision-maker.
  • HBGRDs should give careful consideration to any
    special issues related to the participation of
    vulnerable populations or groups, including
    children, individuals with impaired
    decision-making capacity, and prisoners.
  • During the informed consent process, HBGRDs
    should provide potential participants with
    sufficient information on the nature,
    implications, foreseeable risks and benefits of
    their participation, so that they can
    realistically assess the implications of their
    participation and can make an informed decision
    on whether to participate. This information
    should be presented so as to not constitute an
    improper inducement to participate in the
    research.

35
4. Terms of Participation
  • HBGRDs should have a clearly articulated policy
    on the nature of the feedback that will be
    provided to participants, taking into account any
    domestic legal requirements. This policy should
    cover the feedback of individual-level results,
    if any, as well as aggregate results arising from
    research carried out using human biological
    materials and/or data from the HBGRD.
  • Participants should be provided with the
    opportunity to decide on whether or not to
    receive feedback of individual-level results
    arising from research.
  • As a general rule, non-validated results from
    scientific research using a HBGRDs human
    biological materials and data should not be
    reported back to the participants and this should
    be explained to participants during the consent
    process.
  • Where a HBGRD has offered and the participant has
    elected to receive feedback of individual-level
    results, and depending on the nature of the
    feedback, it may be appropriate for a trained
    professional to provide this feedback to
    participants or for counselling to be available
    to participants.
  • HBGRDs should have a clearly articulated policy
    on whether participants will be re-contacted
    during the course of the HBGRDs existence, the
    situations for which re-contact will be
    permitted, and the conditions that will govern
    re-contact.

36
5. Contents of HBGRDs
  • HBGRDs should have a clearly articulated policy
    and should communicate to potential participants
    which human biological materials and data will be
    collected from them or from other sources, stored
    and used for research purposes.
  • HBGRDs should have a clearly articulated policy
    on whether data will be accessed from health or
    other records, independently assembled, and
    whether or not these data will be linked with or
    stored in the HBGRD. Such a policy should also
    address the issue of secondary use of health and
    other records, especially when combined with
    other data. Where HBGRDs intend to access data
    from health or other records, it should ensure
    that participants are duly informed and that
    their informed consent for accessing such records
    is obtained.

37
6. Protection of Human Biological Materials and
Data
  • HBGRDs should be established, managed and
    governed in such a way as to prevent any
    inappropriate or unauthorised uses of
    participants human biological materials and
    data.
  • HBGRDs should establish policies and procedures
    for the protection of the human biological
    materials and data, especially those potentially
    permitting, whether directly or indirectly, the
    identification of the participant.
  • The HBGRD should ensure that the data and
    information contained within its databases should
    be protected in accordance with applicable
    domestic law, especially in regard to the
    protection of privacy.

38
7. Access
  • HBGRDs should develop clear policies and
    procedures for accessing human biological
    materials and data in their databases, which
    should be based on objective and clearly
    articulated criteria.
  • Access and use of human biological material and
    data should be consistent with the terms of
    participation and should respect the privacy of
    the participant and confidentiality of the human
    biological materials and data.
  • HBGRDs should provide participants with explicit
    information on whether or not their human
    biological materials and data, in whole or in
    part, will be made accessible to third parties
    for non-research purposes.
  • The HBGRD should not make accessible or disclose
    participants human biological materials or data
    obtained for health research purposes to third
    parties for non-research purposes, including to
    insurance providers, employers, or to law
    enforcement agencies, except where required by
    law. The informed consent document should be
    transparent and explicit about any legal
    requirements to share human biological materials
    or data with third parties.
  • Unless strictly necessary, researchers should be
    provided access only to human biological
    materials, data or information that is coded such
    that the participant cannot be identified and
    researchers should be required to not attempt to
    re-identify participants. Such exceptional
    conditions should be clearly disclosed to
    research participants during the informed consent
    process.

39
7. Access
  • 7.F HBGRDs should have a clearly articulated
    policy on whether researchers using its
    database(s) will be allowed to contact
    participants directly.
  • 7.G Given the potentially finite nature of human
    biological materials, HBGRDs should formulate
    criteria for prioritising applications for access
    to the human biological materials.
  • 7.H The terms of access for researchers to the
    whole or a part of the database(s) of an HBGRD
    should be set out in an access agreement.
  • 7.I Where a HBGRD intends to provide access to
    the specimens and samples collected from
    participants, they should develop a material
    transfer agreement or other agreement appropriate
    for that purpose.
  • 7.J HBGRDs should only transfer specimens and
    data when there are adequate standards in place
    regarding privacy of the participant and
    confidentiality of the data, safety and good
    laboratory methods and in accordance with
    applicable law and regulations.

40
8. Qualification, Education and Training
  • The HBGRD should ensure that all of its personnel
    are knowledgeable about its goals and mission.
  • The managing person(s) of the HBGRD should be
    qualified by training and experience to carry out
    its mandate.
  • The managing person of the HBGRD should ensure
    that personnel have the appropriate professional
    qualifications that meet recognised standards,
    underpinned by experience, education and training
    and are assigned responsibilities commensurate
    with their capabilities.
  • The managing person(s) of the HBGRD should
    develop and implement employee training
    programmes.

41
9. Custodianship, Benefit-sharing and
Intellectual Property
  • HBGRDs should have a clearly articulated policy
    on whether participants retain any rights in the
    human biological materials and data, and the
    nature of these rights.
  • Where the HBGRD intends to retain rights to the
    participants human biological materials and/or
    data, it should have a clearly articulated
    policy, which should be explicitly indicated to
    the participant and should be included in the
    consent document(s). Such policy should be
    consistent with applicable law, and regulatory
    and ethical best practices.
  • Benefits arising from research using the HBGRDs
    resources should be shared as broadly as
    possible. Benefits may be shared in different
    ways including the sharing of information,
    licensing, or transferring of technology or
    materials.

42
10. Demise of the HBGRD and Disposal of Materials
and Data
  • The HBGRD should plan for an unforeseen demise,
    such as the end of its funding.
  • The initiators of a HBGRD should consider a
    possible end date for this endeavour.
  • In accordance with applicable law, a HBGRD should
    have a detailed policy setting out the manner in
    which the human biological materials and data
    that it holds will be dealt with in the event of
    its demise.
  • Once a HBGRD is no longer required or is no
    longer of scientific value, the human biological
    materials and data should be disposed of in an
    appropriate way, consistent with the principles
    of consent and privacy.
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