WMA-HDB-Seoul_CHA

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WMA Expert meeting
on Health Databases and Biobanks
Ethical Considerations on Biobanks
Young Joo Cha, MD, PhD
Chung-Ang University College of Medicine
Toward the University of World from Chung-Ang of Korea
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Process in Biobanking
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Biomaterial
Cells
Tissues
Blood
DNA/RNA
Wastes
Information
Collection
○ Independent Collection for
Biobanking vs Banking
Leftover or Surplus
Specimens after Diagnostic
or Clinical Procedures
○ Sample Archiving for
1. Project-based
2. Disease-specific
3. Population-based
Ethical
Issues
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• Past research focused on drugs,
biological products and devices
• Recent research uses stored biological
specimens with genetic tests, which are
stored at biobank
• There must be caution to protect the
confidentiality, privacy and safety of the
subjects
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Different Issues from
Traditional Research
WMA Declaration
on Ethical Considerations
regarding Health Databases & Biobanks
○ Biobank research gives rise to new
ethical challenges
― Samples collected with sensitive
personal information, especially genetic
― Technical Development in Genetic
Testing
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• What kind of consent is needed/In what
case, consent can be waived?
• How to protect the confidentiality and
whether or not disclose the data to
subjects
• Assessment of the risk of the test to the
subject
– What is the risk to a subject and what
is the minimal risk to waive consent?
Main Controversies
Related to Biobank
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Prospective Retrospective
Anonymous
Anonymized
Level of
consent form
What to do
securely
anonymize?
Identifiable
Identified
Cannot be
used without
IRB permission
Reconsent
needed
4 Kinds of Specimen
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Level of Anonymity
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○ Anonymous
○ Anonymized
○ Identifiable
○ Identified
Pseudoanonymization
WMA Declaration
11. The collection, storage and/or reuse of
data and biological material from
individuals capable of giving informed
consent must be voluntary in accordance
with the Declaration of Helsinki. If the data
and biological material are collected for a
given research project, the specific, free
and informed consent of the participants
must be obtained.
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Informed Consent
1. Voluntary consent
2. Well-informed and understand the
purpose of research with its expected
benefits and risks, before obtaining
consents
3. Withdrawal of consents
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The details of future research could not be
known at the time when the consent is
obtained for banking biomaterial
Blanket Consent
Consent to biomedical research
Consent to research on
specific disease (eg,
cancer research)
Consent to a
specific study
SpecificityAutonomy
Level of Consent Procedures
Less restriction on the types of consent allowed
implies increased respect for autonomy.
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Broad Consent
1. Research must be of great
importance.
2. A maximum protection of privacy
must be guaranteed to participants.
3. They must be allowed anytime to
withdraw the consent.
4. Every future research should be
approved by an ethical review board.
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Re-Contact & Re-Consent
○ To get additional or new consent for
every future research question or
technology can be very impractical,
time consuming, expensive, and
even confusing (or harassing or
worrying) to the participants.
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Broad consent has an
advantage
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WMA Declaration
12. If the data and biological material are stored in a Health
Database or a Biobank for multiple and indefinite uses, it is
only ethically acceptable for the individuals to give consent if
they have been adequately informed about:
a. the purpose of the Health Database or Biobank,
b. the nature of the data or material to be collected,
c. the rules of access to the Health Database or Biobank,
d. the governance arrangements,
e. the means that will be used to protect the confidentiality of their
information,
f. the procedure regarding incidental findings,
g. the potential decision to anonymise data, and in case of irreversible
anonymization, the fact that the individual will not be able to know what is
done with their data and biological material, nor will they have the option
of withdrawing their consent.
h. their fundamental rights and safeguards established in this Declaration,
and
i. when applicable, intellectual property issues and the transfer of data to
third countries.
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○ If they are fully anonymized
○ For large collections of human
samples collected for diagnostic or
clinical purposes
― “Leftover or Surplus” Specimens
○ Must be approved by an Ethical
Review Board (ERB)
Waiver of Consent
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Genetic Testing
• Risk for family pressure; family
involuntarily involved to genetic testing
• Privacy of the family revealed
• Giving access to test result; debated/
autonomy centered view vs beneficence
centered view
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Autonomy vs Beneficence
• Autonomy centered view; volunteers
should be given test results and they can
do whatever they wish with information
• Beneficence centered view; volunteers
should be given results only when the
data are validated and clinical utility is
established
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UK Biobank Consent Form (part 1)
I have read and understand the Information Leaflet, and
have had the opportunity to ask questions.
I understand that my participation is voluntary and that
I am free to withdraw at any time without giving any
reason.
I understand that I may be re-contacted by UK Biobank
(e.g. to answer some more questions and/or attend
another assessment visit), but this is optional.
I give permission for access to my medical and other
health-related records, and for long-term storage and
use of this and other information about me, for health-
related research purposes (even after my incapacity or
death).
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UK Biobank Consent Form (part 2)
I give permission for long-term storage and use of my
blood and urine samples for health-related research
purposes (even after my incapacity or death), and
relinquish all rights to these samples which I am
donating to UK Biobank.
I understand that none of my results will be given to me
(except for some measurements during this visit) and
that I will not benefit financially from taking part (e.g. if
research leads to commercial development of a new
treatment)
I agree to take part in UK Biobank.
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• There happens special need in ethical
consideration for biobank.
• WMA declaration is timely in meeting
new needs
• There remains many areas that should
be clearly defined such as level of
consent, re-consent, retrospective data,
and access to the data by the subject
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Conclusions