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A Win:Win for Data Access:Balancing Public Good with
Privacy Concerns
Legal Framework for e-Research Conference
12 July 2007
Gold Coast
Professor Fiona Stanley ACDirector: Telethon Institute for Child Health Research
Executive Director: Australian Research Alliance for Children and Youth
Outline
1. Rationale for data sharing and e-research
2. Population data and record linkage
3. How seeking consent can lead to bias
4. Harmonising privacy and access. Can we have a win:win?
1. Rationale for data sharing and e-research
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Working Group on Data for Science
Wisdom
Knowledge
Information
Data
Wisdom
Knowledge
Information
Data
From Data to Wisdom:Pathways to Successful Data Management for Australian Science
Report of the Working Group on Data for Science
Presenters:Professor Robin Batterham AOProfessor Fiona Stanley AC
Prime Minister’s Science, Engineering and Innovation Council
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Working Group on Data for Science
Our Vision
Australia is managing increasing volumes and complexity
of data to enhance our country’s scientific, economic and
social prosperity and to protect it from threats
Wisdom
Knowledge
Information
Data
Wisdom
Knowledge
Information
Data
Wisdom
Knowledge
Information
Data
Wisdom
Knowledge
Information
Data
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Working Group on Data for Science
Science Data Challenges
• Exponential increase in data assets
• Lack of data in some vital areas
• Increasing diversity of data
• Vulnerability of data
• Lack of capacity in data management
• Missed opportunities to collaborate
• Impediments to discover, preserve, share and re-use data
• Lack of relevant skills
• Lack of global engagement
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Working Group on Data for Science
Vulnerability of Data Assets
Source: The New Yorker
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Working Group on Data for Science
Key Issues
• Digitisation
• Capture
• Preservation
• Storage
• Accessibility
• Security
• Privacy
• Discoverability
• Integration
• Interoperability
• Sharing
• Re-use
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Working Group on Data for Science
OECD
“fostering broader, open access to and wide use of
research data will enhance the quality and productivity
of science systems worldwide.”
ICSU
“Scientific data and information should be as widely
available and affordable as possible…”.
Importance of Open Access and Data Sharing:International Perspective
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Working Group on Data for Science
Bureau of Meteorology
“… foregoing proprietary rights to data and making
them freely available actually benefits the individual as
well as the community at large …”
Importance of Open Access and Data Sharing:Local Perspective
A National Strategic Framework for Scientific Data
• Recommendation 1– That Australia’s government, science, research and
business communities establish a nationally supported long-term strategic framework for scientific data management including guiding principles. policies, best practices and infrastructure
• Recommendation 2– That a high-level expert committee be established to provide
the leadership role in progressing the formation of the long-term strategic framework for scientific data management
The National Network of Digital Repositories
• Recommendation 3– That the necessary policy and programmes be
implemented with a view to establishing a sustainable publicly funded network of federated digital repositories
• Recommendation 4– That the expert committee consider the
development of a strategic roadmap for the implementation and evolution of the national network of federated digital repositories
Data Management, Access, Sharing and Collaboration - Changing the
Culture• Recommendation 5
– That standards and standards-based technologies be adopted and that their use be widely promoted to ensure interoperability between data, metadata, and data management systems, providing authentic users of the data with appropriate processes and safeguards.
Data Management, Access, Sharing and Collaboration - Changing the
Culture• Recommendation 6
– That the principle of open equitable access to publicly-funded scientific data be adopted wherever possible and that this principle be taken into consideration in the development of data for science and programmes.
– As part of this strategy, and to enable current and future data and information resources to be shared, mechanisms to enable the discovery of, and access to, data and information resources must be encouraged
Data Management, Access, Sharing and Collaboration - Changing the
Culture• Recommendation 7
– That funding agencies offer incentives to encourage researchers and institutions to:
• Develop data management plans for each research grant application involving data collection and generation, and that standards be made freely available and widely disseminated so as to encourage best practice in data management
• Introduce policies and practices to encourage collaboration and sharing of data across Australia’s scientific research institutions and across agencies
• Analyse and re-use existing data
Ensuring there are no Regulatory Impediments
• Recommendation 8– That funding agencies such as the NHMRC and
ARC ensure that best practices and policies are developed and followed that allow bonafide researchers to access individual population data, including and linking of data from multiple sources, whilst protecting privacy, and ensuring that ethics committees fully understand these policies and their rationale.
Ensuring there are no Regulatory Impediments
• Recommendation 9– That in the context of developing the strategic
framework for scientific data management, Australia’s intellectual property approaches be checked to ensure they do not impede the sharing of data.
– In particular it should take into account the OECD Committee for Scientific and Technological Policy guidelines on access to research data and the International Council for Science statements about the benefits of sharing data.
Skills for Data Management
• Recommendation 10– That data management expertise becomes a core skill for
researchers, including graduate and postgraduate science students across all disciplines, and that they receive data management training as part of their education.
• Recommendation 11– That the Australian Government give early consideration to
the findings of the e-Research Coordinating Committee regarding changing research behaviour, practices and skills.
CHILD
Community School
Family
Cultural
Economic Political
Social
CIVIL SOCIETY UNCIVIL SOCIETY
Focus on:
Equality/diversity
Trust, care
Collective good
Valuing parents
Valuingchildhoods
Prevention more than cures
Protected environments
Safe places for all
Effective use of helpful technologies
Child needs as well as adults
Workplace
Accepting of:
Inequalities
Fear, violence
Priority for material wealth
Parents not valued
Fast tracking childhoods
Cures more than prevention
Environmental degradation
Safe places for the few
Excessive use of damaging technologies
Adults needs more than children’s
Ecological contexts shaping child development
Trends in Problems Affecting Children & Youth in Today’s World
• Many are increasing in incidence
• Complex problems (eg mental health, obesity)
• Demand complex information to monitor, study & prevent them
• Costly to treat & manage
• Crisis in child & youth services (health, mental health, education & crime)
• Research in silos
• Services in silos
“Law and ethics in population health are having a renaissance. Once fashionable during the Industrial and Progressive eras, the ideals of population health began to wither with the rise of liberalism in the late
20th century. In its place came a sharpened focus on personal and economic freedom. Political attention
shifted from population health to individual health and from public health to private medicine.”
Prof Lawrence O Gostin 2004University of Georgetown
Law and Population Health
New Yorker March 2005
2. Population data and record linkage
What is Record Linkage?
• Brings together records from different sources, relating to the same individual
• Used for: – administration or case management – population based research and policy
• Focus today: on public good i.e. monitoring, research & evaluation to improve the health & wellbeing of the population
WA Maternal and Child Health Research Data Base 1977-2004
1970’s • Public concerns re thalidomide and adverse effects of perinatal care1980/81• Establish 1st Australian linkage of births, deaths and midwives (perinatal)
records (total population)• Establish registers of cerebral palsies and birth defects to link to data base1982/83• Link computerised hospitalisations1990 onwards• Ongoing MCHRDB2004• WA data linkage system
WA Data Linkage Unit
MCHRDB 2004 Onwards
CORE(1980-current)
Midwives notifications*
Birth registrations Hospital Morbidity*Death registrations*
National registers
National Death IndexNational Cancer
Registry
Family links
Marriage registrationsElectoral roll
Birth/death registrations
Commonwealth Data
PBS (Prescription Drug Use)
MBS (Medicare)Australian Childhood
Immunisation Register
Registries
Cerebral PalsyBirth DefectsIntellectual DisabilityCancer
Mental Health
ICHR Studies
Raine StudyWATCH
RASCALSChild Health Survey
Aboriginal Child Health Survey
* geocoded
Advantages of WA Population Data & Record Linkage
eg MCHRDB• 100% sample: unbiased, no one excluded• Cheap cf. seeking consent/ surveys• Valid & reliable data on sensitive issues• Reduces survey burden on populations• Fast, effective linkage technology• Privacy protected• Better data for policy, planning, evaluation• Improve administrative data
Limitations of WA Population Data & Record Linkage
• Information only available on items and outcomes recorded in data bases (breadth > depth)
• Privacy issues still need to be addressed eg ethics committees, understanding of public good by the community
• Need better, complete denominators• Changes in diagnostic classifications present challenges for
temporal analyses• (In)accuracy of recorded information• Incomplete ascertainment• Sample size for rare disorders (APSU)
Antenatal factors in later disease/ disability
• Trends in diseases & disability (complete) • Environmental exposures & later diseases • Birth outcomes in psychiatric patients• Intra-uterine growth & teenage mental illness• Pregnancy problems & later childhood
diseases
Evaluation of medical care
• Increased very preterm survival - problems in survivors
• IVF & cerebral palsy• IVF & birth defects• Reasons for and impact of, increasing
caesarean sections• Effects of increased obstetric intervention• Adverse drug effects
Evaluation of health promotion
• Prevention of cot deaths
• Folate campaign for spina bifida
• Childhood vaccination coverage
• Anti-smoking programs
3. How seeking consent can lead to bias
Consent
• Consent is essential for all research involving participation of individuals– Questionnaires, interviews– Donate blood, tissues– Drug trials etc
• Not all research requires consent
Bias
• Bias is the distortion of the true relationship between exposure and outcome due to flaws in either study design or analysis
• Can give wrong answers
Bias from Non-Participation• Inability to trace/ contact (most common)• Refusal (rare)
Both of these groups very different from participants
• Magnitude and direction not predictable• Not quantifiable• Explain differences in risks between studies• Poor information for health services and epidemiological
research
Source:Hansen, Kurinczuk, Bower & Webb 2002
Cumulative Prevalence of Birth Defects after ICSI & IVF
Does TOP Increase the Risk of Later Breast Cancer?
• Recent meta analysis (53 studies)• Retrospective studies with variable reporting &
response rates RR=1.14(1.09-1.19)• Record linking of abortion data to cancer register data
RR=0.93(0.89-0.96)• Comparisons of abortion registry & self report data
– 24% women with breast cancer and– 27% women without breast cancer reported incorrectly that they had
never had an induced abortion– 27% of women reporting a spontaneous abortion did not report it 20
years later
Record Linkage Impact of Informed Consent
• Tu et al (2004) analysed the impact of informed consent on characteristics of participation in the Canadian Stroke Registry
• Overall participation rate of eligible patients was 39% in Phase 1 & 51% in Phase 2
• Selection Bias - lower in-hospital mortality rate among participants
• Expensive ($500,000 over 2 years for consent alone)
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Consent Rate for Health Research
0%
20%
40%
60%
80%
100%
Population
Pro
po
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n Rochester Clinic
Mayo Clinic
Australia In Person
Australia GP Clinic
USA mailed survey
UK mailed survey
Finland mailed survey
Australia mailed survey
Arguments for not Seeking Consent in Population Based Record Linkage
(for all other studies wherever practical, informed consent should be sought)
• Research is of great benefit to society• Evidence of bias when consent is sought - serious
misinterpretation with implications for health, health services, other
• Very small risks to individuals involved (and may be significant benefits)
• Impractical to obtain consent• Too costly to obtain consent• May actually protect privacy more than in studies
seeking consent (DLU)
Proportion of Ethics Approved Research Projects using Name Identified & Data Linked
Administrative Health Information WA 1990-2003
0
10
20
30
40
50
60
70
80
90
100
Year of Approval
Pro
po
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n o
f R
esearc
h P
roje
cts
(%
)
% data-linked
% name-identified
WA DataLinkage System
Figure Proportions of ethics-approved research projects (N=408) using name-identifiedand data-linked administrative health information in Western Australia 1990-2003
Source: Trutwein, Holman & Rosman (2006)
4. Harmonising privacy and access.
Can we have a win:win?
Record linkage without consent is allowed:
• We are guided by the National Health & Medical Research Council (NHMRC) Australian Health Ethics Committee– Guidelines for researchers and for Human
Research Ethics Committees ( HREC)– Balance public right to privacy against public
right/interest in proposed research/activity– Influenced Privacy Act of 2001
NHMRC Guidelines for Epidemiological Research
• Role of Ethics Committees (composition, information, guidelines)
• Reasons for data collection• Reasons why impracticable to seek consent• Protection of identifiable data- security standards etc• Nominated custodians, etc• De-identified & anonymous analysis• Conform to National Privacy Principles
NHMRC 2001
WA Data Linkage Unit Best Practice for Cross Jurisdictional Linkage(harmonising privacy & encouraging access)
1. Obtain files of identified individual’s records from Custodians (eg. Births, prescriptions, birth defects registries)
2. Link identifiers, but no access to clinical/sensitive data3. Strip off identifying information4. Return to each Data Custodian with a project ID5. Researchers apply to:
1. Institutional NHMRC Ethics Committee2. DLU Confidentiality Committee3. DLU Advisory Committee
6. Researchers go to Data Custodians to obtain de identified linked data set. No individual data available or used(eg. analyse drugs in pregnancy - effects on birth outcomes & birth defects)
Privacy Concerns
• Can’t address if not known
• Public understanding of– Research– Trade offs (protecting privacy/ allowing
access)– Contexts and current legislation and
processes
Canadian privacy activities2004-2006
• 4 workshops on harmonising privacy
• Privacy toolkit
• Privacy audits
• Privacy officers
Source: Slaughter et al, 2006
UK Privacy & Medical Research
Personal data for public good: using health information in medical research
• Increased complex laws/regulations• Variable interpretation• Many projects blocked/delayed• Increase in costs• Poor public awareness of value and methods
of researchCommentary Lancet, 2006
Source: Academy of Medical Sciences, 2006
Our health system needs effective evaluation
• Spiraling costs of care• Increase complex diseases• New technologies, drugs - harmful side
effects• Patient expectations• Concerns over safety• Poor data for service planning
New Yorker May 2003
Are patients morally obliged to participate in research projects as a “mandatory
contribution to public good”, particularly for those aimed at preventing serious harms and
providing important benefits?
John HarrisProf of Bioethics
University of Manchester
“We are optimistic that a win:win is possible: where privacy is protected, where important
health research can proceed. There is evidence that a shift in thinking is possible on
behalf of ethics review committees, regulators, researchers and the public.”
Dr E Meslin 2006
Director Indiana University
Centre for Bioethics
Towards a win:win
1. HRECs understand and accept current guidelines which allow identifiable data for research without consent if privacy issues addressed and rationale acceptable
2. Develop Australian privacy and research best practice for the researchers using personal data
3. Public aware of how personal records are used and how research is done
4. e.Health: ensure records can be used to evaluate health system
“ In the late 20th century, scholars and politicians posed a key question ‘What desires and needs do you have as an autonomous rights bearing person
to privacy, liberty and free enterprise?’ Now it is important to ask another kind of question ‘What
kind of community do you want and deserve to live in, and what personal interests are you willing to forgo to achieve a good and healthy society?’ “
Prof Lawrence O Gostin 2004
University of Georgetown