Governing Biobanks: Challenges and Perspectives

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Governing Biobanks Challenges and Perspectives

• Chih-Hsing Ho, PhD
• Centre for Medical Ethics and Law
• The University of Hong Kong
• chihho_at_hku.hk

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Organic Bank Account

• To safeguard peoples most valuable assets.
  Rather than depositing money in a personal bank
  account, it is a repository for people to put in
  their biomaterials - blood, tissue samples and
  DNA - in order to earn medical interest some
  later day in the form of new knowledge and
  therapies for diseases.
• (TIME, March 2009)

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What does this organic bank look like in
reality.?
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What does the term biobank refer to?
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Different Names?

• genetic databases?
• biosample repositories?
• tissue banks?
• Collections of human biological materials
  (samples) information linkage (data)

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OECD Guidelines on Human Biobanks and Genetic
Research Databases (2009)

• structured resources that can be used for the
  purpose of genetic research, and which include
• (a) human biological materials and/or
  information generated from their analysis and
• (b) extensive associated information

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Different Types of Biobanks

• Taking into consideration the biobanks nature,
  purpose and scope
• Sampling Disease-oriented vs. Population-based
  biobanks
• Business models commercial vs. non-commercial
  biobanks
• Funding public vs. private biobanks
• Scale large vs. small (regional) biobanks

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Types of Samples Data Stored(source Biobanks
in Europe, European Commission IPTS, 2010)

• Types of Materials Stored

• Types of Data Collected and Stored

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Biobank Composition and Purpose(source Biobanks
in Europe, European Commission IPTS, 2010)

• Ownership

• Research Models

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Common Features of Biobanks

• Have an ongoing and open-ended nature, namely
  involving unspecified research in the future that
  challenges the traditional practice of informed
  consent.
• The banked samples and data need to remain
  potentially re-identifiable
• Have a common good focus, more concerned with the
  public benefit future generations than with the
  individual benefit of participants themselves.

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Why do we need biobanks?
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We need larger sample sizes to support in depth
sequencing of large cohorts
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Comprehensive biobanking is gradually maturing..
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The way of sample handling (and storage) has
improved significantly over the last few decades

• Before (1970s)

• Now (2009)

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We need biobanks..

• To Provide larger sample sizes, accurate DNA
  concentration and better DNA quality for genomics
  research
• Genomics studies often require sample aggregation
  from multiple biobanks
• Biobanks now emerging as powerful tools in
  post-genome translational research

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Purposes Application

• To find out the causes of diseases, namely to
  find out the interaction between genetic factors
  underlying common complex diseases (such as
  asthma, diabetes, and heart disease), which are
  caused by a combination of genetic variants and
  environment factors rather than by individual
  genes.
• Translate biomedical research into diagnostic and
  therapeutic applications through pharmacogenomics
  to achieve personalised medicine and improve
  public health.

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Driving Forces the Completion of the Human
Genome Project (HGP)
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From Genetics to Genomics

• The information coming from the HGP makes
  possible the study of human genome, namely the
  entirety of human hereditary information.
• The focus of genomics was no longer on single
  genes or its disorders but on interactions of
  those genes with each other and with the
  environment as well.

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The Low-cost sequencing..

• 1,000 Genome is not a question whether it
  is possible, but when it will be realized. It is
  unimaginable only 4 years ago.
• (Nature, 2007)

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Personalised Medicine

• In a handful of years, your doctor may be
  able to run a computer analysis of your personal
  genome to get a detailed profile of your health
  prospects.
• (Newsweek 15 Oct 2007)

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GWA Studies

• A new method for scientists to strategically
  search genetic makers that involves rapidly
  scanning SNPs across the complete set of human
  genomes to find genetic variations associated
  with a particular disease.
• SNPs- single nucleotide polymorphisms- the most
  common type of genetic variation in individual
  bases that can be used as makers to locate and
  identify genes in DNA sequences.

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What does it mean if a human genome sequence
costs less than 1,000?
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Personalised Medicine

• Reactive medical treatment

• Proactive medical treatment

• Clinical diagnosis and treatment was based on
  patients symptoms and their medical and family
  history.
• Medication in clinics started only after the
  symptoms appeared.

• The idea of customisation of medical treatment in
  healthcare
• All medical decisions and treatment, including
  preventive and therapeutic care being tailored to
  adapt to each individuals particular genetic
  makeup.

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The changing landscape of post-genome science
means

• Biobanks and collections becoming bigger
• Biobanking becoming a specialist and centralised
  infrastructure (core facility)
• Better quality samples and automated tracking
• Collaborative biobank networks for international
  sharing and harmonisation

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Biobanking as a Global Phenomenon

• - Europe (Iceland, the UK, Sweden, Norway,
  Estonia, Germany, Spain, Italy),
• - The United States and Canada
• - East Asia Taiwan Biobank, China Gene Bank,
  China Guangzhou Cohort, Biobank Japan
• - South East Asia Singapore Bio-Bank
  (established in 2002, closed in June 2011 (cost
  around USD 1 million a year to process about
  10,000 samples)

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Biobank Networking International Infrastructure
for Harmonisation

• P3G Public Population Project in Genomics, an
  international consortium aims to build a network
  for sharing and harmonization of governance
  framework for the population genomics community
  across the globe.
• BBMRI a pan-European Biobanking and Bimolecular
  Resources Research Infrastructure covers 30
  countries, including 280 associated
  organizations, most of which are biobank of
  various types. Aims to provide a sustainable
  legal framework to benefit European research in
  life sciences.

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BBMRI Infrastructure
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International framework supporting networking
among independent population-based biobanks
(Source Biobanks in Europe Prospects for
Harmonisation and Networking, 2010)
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P3G Sample and Data Access Policies (Core
elements)

• Conditions of Use
• Compliance with original consents and applicable
  laws and institutional policies
• Access granted for a limited time period (e.g.,
  6 months or a year), after which the
  recipient must reapply
• Primary data must not be patented
• Informing the resource of issues related to
  data integrity as applicable

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Biobank Dilemmas

• Privacy, Confidentiality (Data Security) vs. Data
  Sharing
• Broad Consent vs. Specific Consent
• Networking vs. Harmonisation
• Feedback vs. Right not to know
• Access policies and procedures

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Legal and Regulation Challenges

• Self-governance (IRB/EGC) or Legislations
  (Biobank Act)
• Variation in applicable laws and regulations in
  different regions and countries
• Lack of transparent access policies and
  procedures
• How to set up a suitable governance framework
  responsible stewardship maintaining public trust
  of biobanks

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Why are biobanks controversial? (social
challenges)

• Genetic exceptionalism Stigmitisation
• Privacy and Surveillance
• Fears of privatisation and commercialisation
  (commercial companies owning the genetic
  heritage of a population)

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Different Layers of Consent(Source Hansson et
al)

• Blanket Consent
• Consent to Biomedical Research
• Consent to Research on Specific Disease
• Consent to a Specific Study

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Consent and Privacy

• Individual consent? Group consent?
• How to define groups?
• Who can represent the groups to give consent?
• Confidentiality anonymous coding
  double-coding?
• Privacy autonomy to decide how to use genetic
  information

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Property and Commodification

• Human tissue gifts or commodities
• Human tissue and genetic information have been
  transformed into useful resources of biovalue.
• A gift model implies a tendency to avoid the
  recognition of participants as stakeholders and
  the rearrangement of entitlements for a share of
  profits

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An upstream ethics

• Strong provisions on consent privacy, but
  weak provisions on access ownership.
• The consent mechanism may satisfy the general
  expectation of good ethics at the expense of
  substantive deliberation of the rearrangement of
  rights and benefits related to biobanks.
• Confidentiality narrow view of privacy

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Public Engagement in Biobanks

• A crucial challenge is the question of how to
  link biobanks with the general public and
  society.
• Treating patients and participants as biobank
  stakeholders rather than only donors (gift
  givers).
• The perception of biobanks in society as key
  resource for the advancement of heath care in the
  welfare state.
• Trust and transparency gaining legitimacy for
  biobanks

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Future Direction of Biobanking

• Provide a baseline for operating standards on
  which to build as the state of the science
  evolves (National Cancer Institute, USA)
• Network development for sample and data sharing
  (P3G, BBMRI)
• Harmonise policies and procedures for biobanks
• Public engagement is considered the key to
  achieve good outcomes in biobank governance
• Redistribution of benefits and power in Biobanks

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Thank you for your attention!