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Sourcing health data for open-access collection

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La Trobe University Library partnered with our Health Sciences academics to procure datasets from two Victorian regional health service providers in 2014/15 and from these created a publically available, healthy communities data collection for research purposes

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Sourcing health data for open-access collection

  1. 1. Sourcing health research data for open-access collection Greg D’Arcy (Research Data Project Manager)
  2. 2. 2La Trobe University Aims of Session • Research data management • Open data collection project – issues & requirements • Questions
  3. 3. 3La Trobe University My Background • La Trobe University: MODC Project Manager (2014-2015) • Education Services Australia: Senior Project Manager (2005-2014) • Monash, RMIT Universities: Sessional Lecturer (2004-2006) • Web Content Manager: Australian Taxation Office (2004) • Program Manager: The Salvation Army (2002-2003)
  4. 4. 4La Trobe University Research data management at La Trobe University
  5. 5. 5La Trobe University Research Data Managment • La Trobe University Working party from various business depts • Most universities grappling with the same issues • Managing research data can be complex & messy • There’s always exceptions to the norm Sam Searle, Content and Discovery Services, Griffith University
  6. 6. 6La Trobe University What are research data? 6 “It is not possible to apply a uniform definition of research data across all disciplines. Research data may be numerical, textual, audio-visual, digital or physical, depending on the discipline and the nature of the research.” Source: University of Sydney Research Data Management Policy 2014
  7. 7. 7La Trobe University Why now? • Good practice • Funder requirements • Compliance • Increased citation Australian Code for the Responsible Conduct of Research, states: Policies are required that address the ownership of research materials and data, their storage, their retention beyond the end of the project, and appropriate access to them by the research community.
  8. 8. 8La Trobe University General issues to manage when dealing with research data… • Research data can be digital or analogue • Dealing with sensitive data • Copyright & Licensing • Not all research data will be suitable for Open Access • Issues relating to validation/review of research data (established principles & criteria for journal articles & thesis) • Data Management plans
  9. 9. 9La Trobe University Population Health data collection for the City of Greater Bendigo
  10. 10. 10La Trobe University Some key issues/terms • Research • Ethics • Privacy • Confidentiality • Consent • Risk • Harm • Identifier • Databank • De-identified data • CC-BY
  11. 11. 11La Trobe University ANDS Major Open Data Collections (MODC) project • The project was funded by the Australian National Data Service as part of its Open Data Collections program to support partner institutions make available an internationally significant open research data collection.
  12. 12. 12La Trobe University ANDS Major Open Data Collections (MODC) project • La Trobe University Library partnered with the Building Healthy Communities Research Focus Area (RFA) to trial processes to develop a Healthy Communities Data Collection. • Funders requirements: • There is a demonstrated research need for the data beyond the scope of the institution • The data should be well described and well linked having richly connected data collections and sub-collections • The open data collection must be discoverable through appropriate means including Research Data Australia as well as institutional, international and discipline specific portals
  13. 13. 13La Trobe University The Bendigo Health Population data collection • Health researchers have a major interest in accessing clinical data to support research to inform and improve population health and health services. • Cardiovascular disease is the leading cause of death in Australia, being responsible for 33.7 per cent of all deaths in 2008 (ABS 2010). Furthermore, cardiovascular disease is the second leading cause of the disease burden (18 per cent of the total burden) (Begg et al. 2007). • Curate & identify connections between disparate data sets.
  14. 14. 14La Trobe University Secondary research data from regional health service providers • Bendigo Health: 48,000 patient records relating to Circulatory system diseases (ICD code range of I00–I99) for patients over 40 years of age • Loddon Mallee Murray Medicare Local: 245,000 patient records from General Practices within the Loddon/Murray/Mallee catchment area for a broad range of health issues • Other sources: ABS, AIHW MODC Data collection BH LMMML Other data Curate & identify connections between disparate data sets.
  15. 15. 15La Trobe University Key issues for project team • No precedence for publication of secondary data (methodology, workflow, supporting templates) • Obligations when handling sensitive health data requires systems and process to ensure the security and integrity of the data is managed • Collection, Use & Disclosure of data involving human subjects is subject to ethics approvals • The O in MODC is for Open: third-party material to be licenced under conditions that support re-use & re- purposing
  16. 16. 16La Trobe University Some project house keeping: systems & templates to develop • Schemas / Data dictionary • Data sample • Data extraction plan • Ethics • Secure storage / Access restricted by roles • License agreement • Metadata • Research data management plan • Sensitive data
  17. 17. 17La Trobe University Stage one: data acquisition • Preliminary meetings • Positive response from both health services • “Define area of research interest and we can extract and supply the data” • La Trobe Human Research Ethics Committee approved • More meetings with Health IT Manager, La Trobe Epidemiologist and Library repository staff
  18. 18. 18La Trobe University Stage one: define area of interest Bendigo Health (BH) CIO required detailed scope of intention & data planning for the project, including: • Clear statement of intent – including inputs/outputs • Area of interest (scope) • Any internal resources required • Roadmap & Timeline • May require approval from BH Human Research Ethics Committee (HREC)
  19. 19. 19La Trobe University Stage one: Human Research Ethics • The primary role of Bendigo Health’s Human Research Ethics Committee is to protect the welfare and rights of participants in research. • HREC review research proposals and make judgments on whether risks of the research are justified by the potential benefits. • Must meet the requirements for ethical research within National Statement on Ethical Conduct in Human Research (2007) • Also familiarize yourself with the relevant Commonwealth and State legislation to ensure your project complies with human research and privacy laws
  20. 20. 20La Trobe University Ethics
  21. 21. 21La Trobe University What is human research? • Human research is conducted with or about people through: • Taking part in surveys, interviews or focus groups • Undergoing psychological, physiological or medical testing or treatment • Being observed by researchers • Researchers having access to their personal documents or other materials • The collection and use of their body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath • Access to their information as part of an existing published or unpublished source or database
  22. 22. 22La Trobe University National Statement on Ethical Conduct in Human Research, 2007 (Updated May 2015) • Two themes must always be considered in human research: the risks and benefits of research, and participants’ consent. • The National Statement allows for different levels of ethical review of research, reflecting the difference in degree of risk involved.
  23. 23. 23La Trobe University NS 2.1: Risk and Benefit • The expression low risk research describes research in which the only foreseeable risk is one of discomfort. • The expression negligible risk research describes research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. GUIDELINE 2.1.2: Risks to research participants are ethically acceptable only if they are justified by the potential benefits of the research.
  24. 24. 24La Trobe University NS 2.2: General requirements for Consent • Consent to participate in research must be voluntary and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it. • Depending upon the circumstances of an individual project it may be justifiable to employ an opt-out approach or a waiver of the requirement for consent, rather than seeking explicit consent. GUIDELINE 2.2.1 The guiding principle for researchers is that a person’s decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it. GUIDELINE 2.2.2 Participation that is voluntary and based on sufficient information requires an adequate understanding of the purpose, methods, demands, risks and potential benefits of the research.
  25. 25. 25La Trobe University NS 3.2 Databanks • The National Statement defines databanks as “[A] systematic collection of data … If data are being collected, aggregated and stored with a view to use for future related or as yet unspecified research, this may involve ‘banking’ the participants’ data.” • The term databanks includes databases. • Types of research that commonly make use of databanks include epidemiology, pathology, genetics and social sciences. GUIDELINE 3.2.1 When planning a databank, researchers should clearly describe how their research data will be collected, stored, used and disclosed, and outline how that process conforms to this National Statement, particularly the requirements for consent set out in paragraphs 2.2.14 to 2.2.18. GUIDELINE 3.2.3 Researchers’ use of data from databanks must comply with conditions specified by the providers of the data; in particular, any conditions on the identifiability of the data (see paragraphs 2.2.14 to 2.2.18).
  26. 26. 26La Trobe University NS 5 (Processes of research governance and ethical review) Institutional responsibilities • Research involving no more than low risk can be exempted from review • Institutions may choose to exempt from ethical review research that: a) is negligible risk research (as defined in paragraph 2.1.7); and b) involves the use of existing collections of data or records that contain only non-identifiable data about human beings. • Deciding to exempt research from ethical review still means the research must meet the requirements of the National Statement and be ethically acceptable. GUIDELINE 5.1.8 Research that carries only negligible risk (see paragraph 2.1.7) and meets the requirements of paragraphs 5.1.22 and 5.1.23 may be exempted from ethical review.
  27. 27. 27La Trobe University Privacy
  28. 28. 28La Trobe University Data identifiability • Individually identifiable data: where the identity of a specific individual can reasonably be ascertained. Examples of identifiers include the individual’s name, image, date of birth or address • Re-identifiable data: from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets • Non-identifiable data: where no specific individual can be identified, as the data has never been labelled with individual identifiers or from which identifiers have been permanently removed
  29. 29. 29La Trobe University Legal requirements • Every project will involve the collection, use or disclosure of some piece of information. • Researchers should review ALL Privacy Principles in the relevant legislation to ensure that their project is fully compliant with all aspects of the law. • Researchers are responsible for identifying the relevant Act and guidelines under which an application for approval of a project is made. • If more than one Act (or set of guidelines) applies, all relevant legislative requirements will need to be met, including the obtaining of any necessary approvals from a Human Research Ethics Committee. The statutory guidelines referred to above are not identical, as they must reflect the various statutes under which they are made and any different requirements must be adhered to.
  30. 30. 30La Trobe University Victorian Laws • In Victoria there is a requirement to comply with legislation relevant to human research involving information privacy (Information Privacy Act 2000) and health information (Health Records Act 2001). • The Health Records Act 2001 (Victoria) applies to all health information handled by the Victorian public sector and private sector. There are eleven Health Privacy Principles (HPPs). HPP 1 and 2 govern the collection, use and disclosure of health information, including for the purposes of research. • The Information Privacy Act 2000 (Victoria) regulates the responsible collection and handling of personal information – which includes “sensitive information” but excludes health information by organisations in the Victorian public sector, including universities. Sets out ten Information Privacy Principles (IPPs). IPPs 1, 2 and 10 deal with the collection, use and disclosure of this information for the purposes of research.
  31. 31. 31La Trobe University Commonwealth Law • The Privacy Act 1988 (Cth) outlines thirteen Australian Privacy Principles, which establish requirements for the collection, storage, use and disclosure of personal information and health information. Sections 16A and 16B of the Privacy Act set out certain circumstances in which it is permissible to collect, use and disclose personal information and health information for the purposes of research.
  32. 32. 32La Trobe University Definitions by law • Collection: an organisation or individual collects information if it gathers, acquires or obtains information from any source and by any means, whether that information has been requested or not. Questionnaires, surveys, interviews, focus groups and requests for information held in databases, data sets or institutional records are all examples of how information may be collected. • Use: an organisation or individual uses information if it handles the information in any way. Use of information includes any form of quantitative or qualitative analysis and any inclusion of the information in any form of publication. • Disclosure: an organisation or individual discloses information when it releases information to other organisations or individuals (that is, outside of those who collected the information in the first instance).
  33. 33. 33La Trobe University Step 2: Data cleansing and merging • Data preparation and linkage: • Filter / Screen fields (eg: Pensioners, ATSI) • Aggregation / Band fields (eg: DOB) • BH- and ABS- data were joined on SLA- (‘Statistical Local Area’) codes • ML- and ABS- data were joined on SLA+ML (Medicare-Local) codes • How much data in total? • ML - 221,268 patient records • BH - 40,237 patient records • Other tables incl Measurement; Medication, Diagnosis.
  34. 34. 34La Trobe University Step 3: Deposit to La Trobe repository • Supported by data dictionary & reusable format • Metadata created to describe collection and distribute through La Trobe repository: • Research Data Australia • National Library’s TROVE service • DataCite • Google
  35. 35. 35La Trobe University LTU Research Online repository Title: Population Health data collection for the City of Greater Bendigo. Keywords: Health informatics; Epidemiology; Heart disease; Circulatory system disease; Health data analysis Description: This data collection contains de-identified clinical health service utilisation data from Bendigo Health and the General Practitioners Practices associated with the Loddon Mallee Murray Medicare Local. The collection also includes associated population health data from the ABS, AIHW and the Municipal Health Plans. Health researchers have a major interest in how clinical data can be used to monitor population health and health care in rural and regional Australia through analysing a broad range of factors shown to impact the health of different populations. The Population Health data collection provides students, managers, clinicians and researchers the opportunity to use clinical data in the study of population health, including the analysis of health risk factors, disease trends and health care utilisation and outcomes.
  36. 36. 36La Trobe University Is it worth it?
  37. 37. 37La Trobe University Funders supporting the re-use and re-purposing of open research data The Australian Research Council (ARC) Open Access Policy: • “Any publications arising from an ARC supported research Project must be deposited into an open access institutional repository within a twelve (12) month period from the date of publication.”
  38. 38. 38La Trobe University Accessing and Using Publicly Funded Data for Health Research The National Health and Medical Research Council has drafted a framework of principles for researchers and data custodians to consider when requests or applications are made for access to existing health and health-related datasets for research purposes. 1. Research use of publicly held health and health-related data should be maximised 2. Data custodians should recognise their responsibilities and accountabilities when providing access to data for research. 3. Researchers should recognise their responsibilities and accountabilities when accessing and using publicly held health and health related datasets
  39. 39. 39La Trobe University Lessons learnt • No such thing as a free lunch: Open access projects still require investments of time, money and expertise • Relationships: Bendigo hospital, Loddon Mallee Murray Medicare Local ANDS • New model for releasing secondary data: little precedence for open publication of data alone • Technical: Disparate data from different proprietary technical systems • Managing risk: dealing with sensitive health data under an open access model
  40. 40. 40La Trobe University Key terms (National Statement on Ethical Conduct in Human Research 2007) • Research: Includes at least investigation undertaken to gain knowledge and understanding or to train researchers • Ethics: The concepts of right and wrong, justice and injustice, virtue and vice, good and bad, and activities to which these concepts apply • Privacy: A domain within which individuals and groups are entitled to be free from the scrutiny of others • Confidentiality: The obligation of people not to use private information – whether private because of its content or the context of its communication - for any purpose other than that for which it was given to them • Consent: A person’s or group’s agreement, based on adequate knowledge and understanding of relevant material, to participate in research
  41. 41. 41La Trobe University Key terms (National Statement on Ethical Conduct in Human Research 2007) • Risk: The function of the magnitude of a harm and the probability that it will occur • Harm: that which adversely affects the interests or welfare of an individual or a group. Harm includes physical harm, anxiety, pain, psychological disturbance, devaluation of personal worth and social disadvantage • Identifier: Details attached to data, such as name and/or contact information, that identify an individual • Databank: A systematic collection of data, whether individually identifiable, re-identifiable or non-identifiable • De-identified data: NS avoids term as it’s meaning is unclear. • CC-BY: Attribution Creative Commons license
  42. 42. 42La Trobe University Resources • ANDS ‘Publishing and Sharing Sensitive Data’ - • ANDS ‘Ethics, consent and data sharing’ - level.html • How to confidentialise data: the basic principles, National Statistical Service - +How+to+confidentialise+data:+the+basic+principles • The National Statement on Ethical Conduct in Human Research (2007) - • [DRAFT] Principles for Accessing and Using Publicly-Funded Data for Health Research - • The Australian Code for the Responsible Conduct of Research -