A Win:Win for Data Access: Balancing Public Good with Privacy Concerns

1. 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

2. Outline • Rationale for data sharing and e-research • Population data and record linkage • How seeking consent can lead to bias • Harmonising privacy and access. Can we have a win:win?

3. 1. Rationale for data sharing and e-research

4. Prime Minister’s Science, Engineering and Innovation Council 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 AO Professor Fiona Stanley AC

5. 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

6. 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

7. Vulnerability of Data Assets Source: The New Yorker

8. Key Issues Digitisation Capture Preservation Storage Accessibility Security Privacy • Discoverability • Integration • Interoperability • Sharing • Re-use

9. 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 of science systems worldwide.” ICSU“Scientific data and information should be as widely available and affordable as possible…”.

10. Importance of Open Access and Data Sharing:Local Perspective Bureau of Meteorology “… foregoing proprietary rights to data and making them freely available actually benefits the individual as well as the community at large …”

11. 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

12. 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

13. 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.

14. 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

15. 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

16. 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.

17. 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.

18. 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.

19. CIVIL SOCIETY Ecological contexts shaping child development UNCIVIL SOCIETY 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 Focus on: Equality/diversity Trust, care Collective good Valuing parents Valuing childhoods Prevention more than cures Protected environments Safe places for all Effective use of helpful technologies Child needs as well as adults Social Workplace School Community CHILD Political Economic Family Cultural

20. 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

21. 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

22. New Yorker March 2005

23. 2. Population data and record linkage

24. 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

25. 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

26. WA Data Linkage Unit MCHRDB 2004 Onwards National registers National Death Index National Cancer Registry CORE (1980-current) Midwives notifications* Birth registrations Hospital Morbidity* Death registrations* Family links Marriage registrations Electoral roll Birth/death registrations ICHR Studies Raine Study WATCH RASCALS Child Health Survey Aboriginal Child Health Survey Registries Cerebral Palsy Birth Defects Intellectual Disability Cancer Mental Health Commonwealth Data PBS (Prescription Drug Use) MBS (Medicare) Australian Childhood Immunisation Register * geocoded

27. 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

28. 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)

29. 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

30. 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

31. Evaluation of health promotion • Prevention of cot deaths • Folate campaign for spina bifida • Childhood vaccination coverage • Anti-smoking programs

32. 3. How seeking consent can lead to bias

33. Consent • Consent is essential for all research involving participation of individuals • Questionnaires, interviews • Donate blood, tissues • Drug trials etc • Not all research requires consent

34. 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

35. 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

36. Cumulative Prevalence of Birth Defects after ICSI & IVF Source:Hansen, Kurinczuk, Bower & Webb 2002

37. 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

38. 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)

40. 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)

41. Proportion of Ethics Approved Research Projects using Name Identified & Data Linked Administrative Health Information WA 1990-2003 Source: Trutwein, Holman & Rosman (2006)

42. 4. Harmonising privacy and access.Can we have a win:win?

43. 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

44. 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

45. WA Data Linkage UnitBest Practice for Cross Jurisdictional Linkage(harmonising privacy & encouraging access) • Obtain files of identified individual’s records from Custodians (eg. Births, prescriptions, birth defects registries) • Link identifiers, but no access to clinical/sensitive data • Strip off identifying information • Return to each Data Custodian with a project ID • Researchers apply to: • Institutional NHMRC Ethics Committee • DLU Confidentiality Committee • DLU Advisory Committee • 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)

46. Privacy Concerns • Can’t address if not known • Public understanding of • Research • Trade offs (protecting privacy/ allowing access) • Contexts and current legislation and processes

47. Canadian privacy activities2004-2006 • 4 workshops on harmonising privacy • Privacy toolkit • Privacy audits • Privacy officers Source: Slaughter et al, 2006

48. 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

49. 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

50. New Yorker May 2003