Crawley-Copenhagen-WMA-Health-Databases-_-Biobanks-Francis-P-Crawley-15-09-15_2_0

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Health Databases & Biobanks
Promoting & Protecting Public Health
through Custodianship
The WMA Copenhagen Meeting on
Health Databases and Biobanks
Copenhagen, Denmark
15-16 September 2015
Francis P. Crawley
Clinical Practice Alliance – Europe
fpc@gcpalliance.org
Health Databases & Biobanks
The Purpose
to promote
public health & individual health
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Three Key Concepts
• Health is our greatest good. Promoting
health is a first responsibility of
governments and our best investment.
• ‘My health is (y)our health; (y)our health is
my health.’
• Health is a shared interest and a shared
responsibility.
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The Core Value
‘It is the duty of the physician to promote and
safeguard the health, well-being and rights of
patients, including those who are involved in
medical research. The physician’s knowledge
and conscience are dedicated to the fulfilment of
this duty.’
Paragraph 4, Declaration of Helsinki, 2013
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Considerations Regarding the WMA Draft
Declaration on Ethical Considerations
Regarding Health Databases and Biobanks (2015-03-18)
• Distinguish between human persons &
communities and materials & data derived
from human persons
• Achieve a renewed concept of consent
! participatory consent
• Custodianship should be the principle
framework for health databases & biobanks
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Custodianship
• Health data may not be considered as other kinds of
data; health data is a public good (res publica)
• Health data, healthcare practice, health sciences,
health knowledge may not be owned
• Replace ‘ownership’ with ‘custodianship’
• Health (data) custodianship = ‘the responsible
reception, organization, protection, and sharing of
health data, information, and knowledge’
‘the good health custodian’ = ‘the good health librarian’6
The Need for Public Authorities
• The collection, storage, and use of health
databases & biobanks should be overseen,
regulated, and evaluated by public (health)
authorities
• Current (research) ethics committees should
maintain a focus on research on human
persons
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