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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 AC
         Director: 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
                   Prime Minister’s Science, Engineering and Innovation Council



                   From Data to Wisdom:
                   Pathways to Successful Data




                                                                                       Working Group on Data for Science
                   Management for Australian Science

                   Report of the Working Group on Data for Science        Wisdom


                   Presenters:                                           Knowledge
                   Professor Robin Batterham AO
                                                                         Information
                   Professor Fiona Stanley AC
                                                                            Data




Working Group on Data for Science                 4
                                    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




                                                                  Working Group on Data for Science
                                      Wisdom
                                       Wisdom


                                     Knowledge
                                      Knowledge


                                      Information
                                     Information
                                         Data
                                        Data




Working Group on Data for Science               5
                             Science Data Challenges

      • Exponential increase in data assets
      • Lack of data in some vital areas
      • Increasing diversity of data
      • Vulnerability of data




                                                                   Working Group on Data for Science
      • 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



Working Group on Data for Science       6
                              Vulnerability of Data Assets




                                                             Working Group on Data for Science
     Source: The New Yorker




Working Group on Data for Science          7
                                      Key Issues



    • Digitisation                  • Discoverability    • Accessibility
    • Capture                       • Integration        • Security




                                                                           Working Group on Data for Science
    • Preservation                  • Interoperability   • Privacy
    • Storage                       • Sharing
                                    • Re-use




Working Group on Data for Science             8
          Importance of Open Access and Data Sharing:
                                    International Perspective




      OECD
        “fostering broader, open access to and wide use of
        research data will enhance the quality and productivity




                                                                  Working Group on Data for Science
        of science systems worldwide.”


      ICSU
        “Scientific data and information should be as widely
        available and affordable as possible…”.




Working Group on Data for Science               9
          Importance of Open Access and Data Sharing:
                                    Local Perspective




      Bureau of Meteorology

           “… foregoing proprietary rights to data and making




                                                                       Working Group on Data for Science
           them freely available actually benefits the individual as
           well as the community at large …”




Working Group on Data for Science          10
 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.
CIVIL SOCIETY         Ecological contexts shaping child development       UNCIVIL SOCIETY

Focus on:                                                                   Accepting of:

Equality/diversity                                                          Inequalities

Trust, care
                             Social                 Workplace               Fear, violence

Collective good                                                             Priority for material
                                                                            wealth
Valuing parents               Community              School                 Parents not valued
Valuing
childhoods                            CHILD                                 Fast tracking
                                                                            childhoods
Prevention more
than cures                                                                  Cures more than
                      Economic                                Political     prevention
Protected
environments                               Family                           Environmental
                                                                            degradation
Safe places for all
                                                                            Safe places for the
Effective use of
                                          Cultural                          few
helpful
technologies                                                                Excessive use of
                                                                            damaging
Child needs as well                                                         technologies
as adults
                                                                            Adults needs more
                                                                            than children’s
  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 Population Health

 “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 2004
                                          University of Georgetown
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 care
1980/81
• 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 base
1982/83
• Link computerised hospitalisations
1990 onwards
• Ongoing MCHRDB
2004
• WA data linkage system
                   WA Data Linkage Unit
                  MCHRDB 2004 Onwards
                                                      National registers
     Family links                  CORE
                                                      National Death Index
                              (1980-current)            National Cancer
 Marriage registrations
      Electoral roll              Midwives                  Registry
Birth/death registrations      notifications*
                             Birth registrations
                            Hospital Morbidity*          ICHR Studies
       Registries           Death registrations*
                                                           Raine Study
     Cerebral Palsy                                          WATCH
      Birth Defects                                         RASCALS
       Intellectual          Commonwealth Data         Child Health Survey
        Disability                                      Aboriginal Child
         Cancer              PBS (Prescription Drug      Health Survey
     Mental Health                    Use)
                               MBS (Medicare)
                             Australian Childhood        * geocoded
                            Immunisation Register
    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
Cumulative Prevalence of Birth Defects
           after ICSI & IVF




                   Source:Hansen, Kurinczuk, Bower & Webb 2002
  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)
                Consent Rate for Health Research

             100%
                                        Rochester Clinic
             80%
Proportion




                                        May o Clinic
             60%                        Australia In Person
                                        Australia GP Clinic
             40%
                                        USA mailed surv ey
             20%                        UK mailed surv ey
                                        Finland mailed surv ey
              0%
                                        Australia mailed surv ey
                        Population


                                                              7
 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
   Figure Proportions of ethics-approved research projects (N=408) using name-identified
      and data-linked administrative health information in Western Australia 1990-2003



                                                  100
                                                                                                      WA Data
                                                                                                      Linkage System
                                                   90
            Proportion of Research Projects (%)




                                                   80

                                                   70

                                                   60

                                                   50

                                                   40

                                                   30

                                                   20                                                                          % data-linked

                                                   10                                                                          % name-identified

                                                    0
                                                      90


                                                             91


                                                                    92


                                                                           93


                                                                                  94


                                                                                         95


                                                                                                 96


                                                                                                         97


                                                                                                                98


                                                                                                                         99


                                                                                                                                00


                                                                                                                                       01


                                                                                                                                              02


                                                                                                                                                     03
                                                    19


                                                           19


                                                                  19


                                                                         19


                                                                                19


                                                                                       19


                                                                                               19


                                                                                                       19


                                                                                                              19


                                                                                                                       19


                                                                                                                              20


                                                                                                                                     20


                                                                                                                                            20


                                                                                              Year of Approval                                     20


                                                                                                                                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 data
3.     Strip off identifying information
4.     Return to each Data Custodian with a project ID
5.     Researchers apply to:
      1. Institutional NHMRC Ethics Committee
      2.   DLU Confidentiality Committee
      3.   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 activities
           2004-2006
•   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 research
                           Commentary 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 Harris
                                     Prof 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

								
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