Presentation given by Kate LeMay at the 'Sharing Health-y Data: Challenges and Solutions' workshop, held at The Menzies Research Institute (Hobart, Tasmania) on 28th June 2016. The event was co-hosted by ANDS and the University of Tasmania library

1. Kate LeMay
Publishing and sharing sensitive data
Senior Research Data Specialist
28 June 2016

2. The Australian National Data Service (ANDS) makes
Australia’s research data assets more valuable for
researchers, research institutions and the nation.

3. Workshop outcomes
• What health and sensitive data are
• What legal and ethical issues you need to consider
before publishing and sharing health data
• How to plan for data sharing in research ethics
applications and consent forms
• How data may be confidentialised
• How to licence human data for re-use
• What’s happening at the Menzies

4. Why would you share data??!
Data
sharing
Discoverable
and citable
Pubs with
data cited
more
often
Collaborations
and
publications
Secure and
ongoing
storage in
repositories
Replicate or
extend
findings
Reduces
burden on
participants
Ethical
obligation
(clinical
trials)
Which data???

5. Sensitive data
What makes
medical and health
data sensitive?
Personal (identifiable) information
+ potential for harm or discrimination

6. It can be done safely and ethically
Plan to publish

7. DISCUSSION: 5 minutes
Concerns about sharing
data?
What do you hope to get
out of this workshop?

8. Data sharing landscape
Funders
NHMRC Statement on Data Sharing
New Human Research Ethics Application (HREA – replaces NEAF)
National Statement on Ethical Conduct in Human Research (S2 consent to future use)
Discovery, linkage Data Management Plan

9. International funders
Many are
mandating
data sharing

10. Journals
BMJ 2015;350:h2373
http://journals.plos.org/plosone/s/data-availability
http://www.icmje.org/news-and-editorials/M15-2928-PAP.pdf

11. …researchers will consider and document the following:
• participant consent to retain or re-use de-identified data
• length of time data must be kept, how and by whom it will be archived,
disposed of or destroyed at the end of the retention period. Secure storage
and controlled access
• metadata (description of the anticipated data to be generated), which will point
to the original data, so the original data is discoverable accessible and, where
appropriate, shareable beyond the end of the project
University of Tasmania
http://www.utas.edu.au/__data/assets/pdf_file/0008/412001/Management-of-Research-Data-Procedure.pdf

12. Data sharing is on the horizon

13. Plan to Publish
NHMRC Statement on Data Sharing (2016)
https://www.nhmrc.gov.au/grants-funding/policy/nhmrc-statement-data-sharing

14. Ethics and consent

15. Legal: Privacy Law
Privacy Act (1988, s6)
Personal information
+
One or more of: health, genetic, biometric, political
=
Sensitive information
Cannot be used beyond original purpose of collection
without consent

16. Ethics
• Informed consent
• Avoid harm (=remove/minimise sensitivity)
• Where possible, modify data to protect
privacy i.e. confidentialising data
• Conditions around access to data
• Ethics committee approval

17. Informed consent
1. Avoid precluding data confidentialisation,
publication and sharing
2. State possibility of future data publication
3. State conditions of access
4. Document consent with collected data to inform
subsequent users
Example wording available in ANDS Guide to
Publishing and Sharing Sensitive Data

18. Consent form wording examples
‘A de-identified copy of this data may be used for other research purposes.
However, your anonymity will at all times be safeguarded.’
https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-
research-ethics-manual-2014 Section 22 Appendix 1
http://www.data-archive.ac.uk/media/112638/ukdamodelconsent.pdf

19. Screenshot from: http://genomicsandhealth.org/consent-tools-read-online
Consent form wording examples

20. Consent form examples: Discussion
Translational Cancer Research Network (NSW Health)
http://www.tcrn.unsw.edu.au/sites/default/files/uploads/images/HSA%20Biobank%20C
onsent%20Form%20V%201%201.pdf
Interuniversity Consortium for Political and Social Research. Guide to Social Science
Data Preparation and Archiving: Best Practice Throughout the Data Life Cycle. Ann
Arbor, MI: ICPSR. (Page 13)
http://www.icpsr.umich.edu/files/ICPSR/access/dataprep.pdf
Sage Bionetworks Participant-Centered Consent (PCC) toolkit
http://sagebase.org/platforms/governance/econsent/
Toolkit available from https://github.com/Sage-Bionetworks/PCC-Toolkit

21. Something to think about later
Open consent for genomic data!
Personal Genome Project
http://www.personalgenomes.org/
Some useful articles about informed consent for open genomic data
http://arep.med.harvard.edu/pdf/Lunshof08.pdf
http://lsspjournal.springeropen.com/articles/10.1186/s40504-014-0020-9
http://genomesunzipped.org/2010/10/why-public-genomics-is-not-a-
purely-personal-decision.php#more-1186

22. Confidentialising data

23. Data identifiability
• Individually identifiable
• Re-identifiable
• Non-identifiable
National Statement on Ethical Conduct in Human Research 2007 (Updated May 2015). The
National Health and Medical Research Council, the Australian Research Council and the
Australian Vice-Chancellors’ Committee. Commonwealth of Australia, Canberra. Page 27

24. Confidentialisation
Removing or altering data so that the people or
subjects of data cannot reasonably be identified
• De-identifying the data (‘how to’ steps in the
ANDS Guide)
• Continuing to manage the risk
Confidentialised data is no longer sensitive
and can be shared

25. Confidentialisation
1. Direct identifiers
• Remove ALL
• Examples
1. Name
2. Address
3. Phone number
4. Medical device identifiers
2. Indirect identifiers
• 2 or more present may identify participants (triangulation)
• Remove or modify
• Examples
1. Sex
2. Place of birth
3. Household and family composition

26. Confidentialisation
Removing versus modifying?
• Remove direct identifiers
• Remove OR modify indirect identifiers
Modifying
• If removal de-values the dataset
• Combine responses into categories
• Top and bottom coding
• Rounding times, dates, measurements
• Cell suppression

27. Licensing

28. What is a licence?
• A licence sets out how data can be (re)used and
attributed
• All Australian data intended for reuse should have
a licence

29. What is a licence?

30. What is a licence?

31. Why apply a licence?
 Use a licence to tell
others how they can
legally share your work
 Promotes re-use and
enables collaboration
 Gives the owner control
and credit

32. AusGOAL licensing framework
AusGOAL contains eight licensing options:
 Six Australian Creative Commons (CC) Version
4.0 licences
 Restrictive Licence Template (RLT)
 BSD 3-Clause Software Licence
ANDS endorses AusGOAL
Wide support by Federal and
State Governments
http://www.ausgoal.gov.au

33. Licensing and data
NOT FOR DATA


Slide is courtesy of Baden Appleyard – Director of AusGOAL

34. How open can I be?
 Consent? (For what?)
 Potential for harm/discrimination?
 Data modified to address identification, limit harm?
 HREC approval

35. When CC licence not suitable
Restrictive Licences can ‘bespoke’ your
conditions of access and use
http://www.ausgoal.gov.au/restrictive-
licence-template
*Check with your DM support,
School/Department/Institution to see if
one already exists for you to repurpose

36. How do I apply a licence?
• You must ‘own’ the data to apply the licence
• Look at your institutional IP policies
• When partnering: agree – before collecting the
data – who can apply the licence and what that
licence will be.
• Include this info in HREC application

37. How do I apply a licence?
• Just apply the marking (image) and/or statement
• http://creativecommons.org/about/downloads
• http://www.ausgoal.gov.au/sample-copyright-
notices
• Make it visible on the document, repository record,
and/or attached to the data

38. Repositories and Discovery

39. Depositing your data
What is a data repository?
A research data repository is a
managed environment capable of
storing and sharing (largely) digital
data. The data repository supports
the process of curating, preserving,
and sharing research data.

40. Choices about publishing
1. Metadata only
2. Metadata plus mediated access
3. Metadata plus open access
What is metadata?
• Location
• Institutional repository
• Discipline specific repository
• General repository

41. Repositories
41
(search for repositories)
DOI

42. Examples of published medical and health data

48. ANDS Guide to Publishing and Sharing
Sensitive Data
http://www.ands.org.au/guides/sensitivedata
Guide
Conditional
access
Ownership
Licensing
Repositories
How to
confidentialise
Ethics and
consent

50. Take away
Plan to publish
You have choices
Published is not the same as open
The library and ANDS can help!

51. http://www.ands.org.au/working-with-data/enabling-data-reuse/medical-and-health

52. 23 (research data) Things
JOIN our virtual group: 23 Things Health Data
Community Group (4 weekly)
Kate LeMay and Julie Toohey (Griffith) co-
organisers

53. Senior Research Data Specialist
kate.lemay@ands.org.au
Kate LeMay
With the exception of logos, third party images or where otherwise indicated, this
work is licensed under the Creative Commons Australia Attribution 3.0 Licence.
ANDS is supported by the Australian
Government through the National Collaborative
Research Infrastructure Strategy Program.
Monash University leads the partnership with
the Australian National University and CSIRO.