WMA-HDB-Seoul_SNAEDAL

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Health Databases and Biobanks
A WMA expert meeting in Seoul
30.-31. January 2016
Jon Snaedal
Chair of the WG
Historical perspectives
The WMA has been concerned about health
data for decades.
As early as 1973 in a “Resolution on Medical
Secrecy” addressing Computers and Confidentiality
in Medicine (27th GA in Munich):
GA in Venice in 1983, short statement
GA in Washington 2002, extensive declaration
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GA in Washington DC in 2002
Adoption of a Declaration:
The WMA Declaration on Ethical Consideration regarding Health
Databases:
• Strong association to the Declaration of Helsinki (DoH).
• Central ethical principles:
– Access of information by patients
– Confidentiality
– Consent
– De-identified data
2002 -2012
• The 2002 Declaration became a solid base for
the WMA to use but otherwise, the document
was not prominent outside the Association.
• During the next decade there was much
debate on the DoH with new, minor revision in
2008 followed by an in depth revision process
starting in 2011, ending in a new policy in
2013.
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The 2013 revision on the DoH
• During the revision, an extensive external
consultation was used.
• The new (and current) version was adopted in
2013 containing a revised paragraph on health
data.
• The work on a renewed policy on Health Data
had then already begun
Par 32 in DoH
For medical research using identifiable human material or data,
such as research on material or data contained in biobanks or
similar repositories, physicians must seek informed consent for
its collection, storage and/or reuse. There may be exceptional
situations where consent would be impossible or impracticable
to obtain for such research. In such situations the research may
be done only after consideration and approval of a research
ethics committee.
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Revision process on the Health Data
• Started in 2012 at the Council meeting in Bali and
a WG was established
• At GA in Fortaleza 2013, the scope was increased
to cover data and material in Biobanks as well
• At GA in Durban 2014, it was decided to have an
open consultation with a subsequent expert
meeting in Copenhagen
• At GA in Moscow 2015, the open consultation
had ended, a decision of a new expert meeting in
Seoul
Types of databases
• Not single records, even if in electronic form
• Not a collection of records in a hospital/health
institution even if kept in a central way
• Data collected for research
• Data collected for quality assurance
• Data collected for epidemiology (cancer registries
etc.)
• Data from several sources/databases
• Clouding
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The importance of Databases
• Hardly any research is conducted without the
use of electronic database
• The use has shifted from gathering
information for a specific purpose to data that
are collected for different purposes
• Extremely large databases are increasingly
established
Some general issues
• For the WMA, the Health Data and Biobank
policy must be in line with the DoH, not only
by referring to it, but also in content.
• The policy must be accepted by members
from all regions of the world
• There is a wish that the policy will have
influence beyond the member societies
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Identification of data and material
Different concepts, to some extent overlapping:
• Identifiable
• Non-identifiable
• Anonymisation
• Pseudo-anonymisation
An issue to solve:
The problem of inherently identifiable data and
material (specific cases, genetics)
Some ethical principles
• The issues of privacy, self determination and
confidentiality are not very controversial
• The right of individuals to decide over their
data is however debated:
– For data to be included (some legal aspects)
– To receive information on which data are included
– To correct data
– To withdraw data from a database
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Consent issues
• Informed consent for specific purposes
• Legal requirements for data collection (not
requiring consent)
• Consent for further/later use:
– For the same disorder
– For related disorders etc.
– For any use
Research Ethics Committees (REC)
Central players for securing good ethical conduct
The role of REC increases if the consent practice
decreases.
Problem:
Worldwide, the construction and quality of REC
differs
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Governance
• Purpose and content
• Consent and time limitation, privacy and
autonomy
• Who will have access?
• Responsible person(s)
• How to handle enquiries and complaints
• Security measures
Biobanks
• Biobanks contain data and material
• Same central ethical issues as by databases
• Same security issues
Specific aspects:
• Handling of material
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Security
• Security breaches have become a major issue,
exemplified by infamous hacking
• The value of health data is greater than most
health professionals realize
• By linking databases, there might be an
increased risk of breaches