29e Confrence internationale des commissaires à la protection de la ...

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Oct 23, 2013 (3 years and 10 months ago)

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29e Confrence internationale des
commissaires àla protection de la
vieprive
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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29e Confrence internationale des
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Pr Bartha Maria Knoppers
Canada Research Chair in Law and Medicine
Genetics and Society Project
Universityof Montreal
Privacy & Population Genomics
A Simulated Marriage?
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
NCENCE
Wordwide, there are over 120 population-based
biobankseach with >10,000 participants
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Large population-based studies around the world
Principal Outcomes
% of studies
General focus
55 %
Cardiovascular diseases
20 %
Cancer
15 %
Other (diabetes, dementia, etc.)
10 %
29e Confrence internationale des
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CE Recommendation Rec(2006)4 of the Committee of Ministers to member
states on research on biological materials of human origin, March 2006
Article 17
A population biobankis a collection of biological materials that has the
following characteristics:
Council of Europe

The collection has a population basis;

It is established, or has been converted, to supply biological materials or
data derived therefrom
f
or multiple future research projects;

It contains biological materials and
associated personal data, which may
include or be linked to genealogical,
medical and lifestyle data
a
nd which
maybe regularly updated;

It receives and supplies materials in an organised
m
anner.
29e Confrence internationale des
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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LowranceWW. Access to collections of data and materials for health research. Medical
Research Council and WellcomeTrust, 2006, p.36
“Few issue clusters are identifiedby researchersas
sourgentlyneedingresolutionas thosesurrounding
confidentialityand anonymisation. Theyare not
unique to data sharing activities, but theyare central
to them.”
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Knoppers BM, Saginur M. The Babel of genetic data terminology. Nature Biotechnology. 2005; 23(8):925-7
29e Confrence internationale des
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Identifiability“Reasonable/Practicable”
Council of Europe
Recommendation No. R (97) 5
on the Protection of Medical Data (Feb. 13, 1997)
“An individual shall not be regarded as identifiable if
identification requires an unreasonable amount of
time and manpower.”
29e Confrence internationale des
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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29e Confrence internationale des
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Protection of Genetic Data
Four Major Different Normative Approaches
to Genetic Information
Personal Information Approach-Genetic information in its definition of personal
information.
Sensitive Information Approach–Prohibits the processing for sensitive data
unless law requires it, for public health purposes, or explicit consent is obtained.
Health or Medical Information Approach–Covered expressly or impliedly by the
definitions of health or medical information.
Genetic Information Approach–Accords special status to genetic information and
defines what constitutes genetic information and distinguishes it from other types of
data, general personal information and health information.
29e Confrence internationale des
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Protection of Genetic Data
as Sensitive Information
E.C. (Independent Expert Group)
Ethical, Legal and Social Aspects of Genetic Testing: Research, Development and
Clinical Applications(2004)
“Geneticdata of importance in a clinicaland/or family
contextshouldreceivethe samelevelof protection
as othercomparablysensitive medicaldata.”
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Protection of Genetic Data as Personal
“PIPEDAdoes not use the term ‘genetic information’
in the definition, it is clear that the comprehensive
definition of personal health information includes
protection for an individual's genetic information.”
Source: Matthew Taylor “Human Rights Issues Related to Genetic Information and Privacy”in A Brave New
World: Where Biotechnology and Human Rights Intersect(2005)
29e Confrence internationale des
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Public Population Project in Genomics
A consortium dedicated to fostering international collaboration
between researchers and projects in the field of population
genomics
www.p3gconsortium.org
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Major goals of P3G
•boost sample sizes to several million subjects
•allow powerful gene-environment studies of most common
diseases within 10 years instead of 15-25 years.
•address needs for replication
•allow comparisons of genetic effects in different environments
•sharing the large costs across nations
•enhance the exchange of information
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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P3G Charter Members
* FoundingCharter Members
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Paul Burton, UK BioBankTechnical Report 2005
How long does it take to reach 10,000 cases
in a cohort with 500,000 cases?
Breast cancer (F)17 yrs
Colorectal cancer
Prostate cancer (M)
Lung cancer
Stroke
MI and coronary death
Diabetes mellitus
COPD
Hip fracture
Alzheimer’s disease
Parkinson’s disease23 yrs
22 yrs
22 yrs
34 yrs
18 yrs
8 yrs
6 yrs
13 yrs
21 yrs
18 yrs
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Genomics and Biochemical Investigations
KnowledgeCuration and Information Technology
Ethics, Governanceand Public Engagement
Epidemiologyand Biostatistics
P3G Workinggroups
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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P3G
Observatory
DESIGN OF
STUDI
ES
ETHICS AND
GOVERNANCE
IT AND
COMPUTER
SCIENCE
STATISTICS
CONTEMPORARY
BIOBANKING
INFORMATION
COLLECTION/
PROCESSING
KNOWLEDGE
TRANSFER
Consensus
d
efinition
of terms in th
e field o
f

biobanking
Reference Tools for
Power Calculation
Referen
c
e proced
ures for
sample collection,
management and storage
Guiding Princip
l
es,
Legislation, and
Background Papers on
Population Genomics
Genoty
ping data anal
y
s
is
Public Databases
Tag SNP Selection Programs
Genotypes Analysis Software
Referen
c
e to
ols for
statistical analy
s
is
Referen
c
e to
ols for
preparation of
publications
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Characteristicsof the genericdata set
Comprehensive enough to ensure the realization of valid research
Small enough to encourage buy-in.
NOTa prescriptive list of allthe variables to be collected by a biobank
100 data items (essential and extended) and 100 optional items
15-25 % of the data items covered in a specific biobank
Approach in genetics: consent, confidentiality, access,
commercialization, and governance
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Aliquot: A portion of a sample of biological
material that has been divided into
separated parts.
Anonymization:Theirreversible removal
of personal identifiers from data or
samples, such that no specific individual
can be identified.
Audit: A documented review of procedures
in order to evaluate adherence to written
standards operating practices (SOPs) or
laws and regulations (adapted from ISBER
Best Practices, 2005).
Biobank/biorepository: An organized
collection of human biological material and
associated information stored for one or
more research purposes
Examples
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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P3G Charter of Fundamental Principles
PROMOTION OF THE COMMON GOOD-P3G will optimise the benefits of
collaborative research publicly-funded research for the benefit of all.
RESPONSIBILITY-Protection of the interests of all affected stakeholders
including families, groups, populations, researchers and research sponsors is the
highest priority. Every effort will be made to respond to the concerns of
stakeholders in a timely and appropriate manner.
MUTUAL RESPECT-The development and sustainability of P3G is based on
responsibility, collaboration, co-operation, trust and mutual respect for others,
which includes recognition of cultural diversity and the scientific specificity of the
projects involved
ACCOUNTABILITY-All standards, processes and procedures will be
transparent and clear, developed on the basis of consensus, and aim to create
best practice in the networking of population genomics resources.
PROPORTIONALITY-All research materials (such as data and sample) must be
protected to the highest standards of privacy and propriety, while at the same time
allowing and promoting the free exchange of ideas, data sharing and openness
for the benefit of all.
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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CARTaGENE project
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Samplesand Data Access Policy
Objectives of the project
General Principles
Samplesand Data Access Committee
Samplesand Data Access
Limitson the Use of CARTaGENE
Privacy Concerns
Access to Information for Participants
MaterialTransfer Agreement
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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HUGO EthicsCommittee
Recognizing
The potentialglobal good arisingfromgeneticresearch;
The scientificand clinicaluses of genomicdatabases;
The potentialfor conflictsbetweenthe free flow of information thatis
crucial to researchadvancesand the legitimaterightsto return from
researchexpenditure;
The potentialriskof misusinggeneticdata;
The needto rapidlyplace primarygenomicsequencesin the public
domain.
Statementon HumanGenomicDatabases, 2002
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Recommendations
Humangenomicdatabasesare global public goods.
Knowledgeusefulto humanhealthbelongsto humanity.
Humangenomicdatabasesare a public resource.
All humansshouldsharein and have accessto the benefitsof databases[…]
HUGO EthicsCommittee(continued)
Statementon HumanGenomicDatabases, 2002
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INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFEREINTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERE
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Privacy & Population Genomics
A Real Marriage?
«acceptingbenefitfrompastmedicalresearch,
inherentin the utilisation of medicalservices,
carries someexpectation of a willingnessto
participatein researchfor the commongood»
BioethicsAdvisoryCommittee, PersonalInformation in BiomedicalResearch
, Singapore, 2007