Kate LeMay

Publishing and sharing sensitive data

Senior Research Data Specialist

28 June 2016

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

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

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???

Sensitive data

What makes medical and health

data sensitive?

Personal (identifiable) information

+ potential for harm or discrimination

It can be done safely and ethically

Plan to publish

DISCUSSION: 5 minutes

Concerns about sharing

data?

What do you hope to get

out of this workshop?

Data sharing landscapeFunders

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

International funders

Many are

mandating

data sharing

Journals

BMJ 2015;350:h2373

http://journals.plos.org/plosone/s/data-availability

http://www.icmje.org/news-and-editorials/M15-2928-PAP.pdf

…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

Data sharing is on the horizon

Plan to Publish

NHMRC Statement on Data Sharing (2016)

https://www.nhmrc.gov.au/grants-funding/policy/nhmrc-statement-data-sharing

Ethics and consent

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

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

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

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

Screenshot from: http://genomicsandhealth.org/consent-tools-read-online

Consent form wording examples

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

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

Confidentialising data

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

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

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

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

Licensing

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

What is a licence?

What is a licence?

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 controland credit

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

Licensing and data

NOT FOR DATA

Slide is courtesy of Baden Appleyard – Director of AusGOAL

How open can I be?

Consent? (For what?)

Potential for harm/discrimination?

Data modified to address identification, limit harm?

HREC approval

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

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

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

Repositories and Discovery

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.

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

Repositories

41

(search for repositories)

DOI

Examples of published medical and health data

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

Take away

Plan to publish

You have choices

Published is not the same as open

The library and ANDS can help!

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

23 (research data) Things

JOIN our virtual group: 23 Things Health Data

Community Group (4 weekly)

Kate LeMay and Julie Toohey (Griffith) co-

organisers

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.