Sarah Olesen 16 March, 2016sarah.Olesen@biotext.com.au

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Health-y sharing of human data

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Plan ahead where possible

It can be done safely, ethically to great success

Who are ANDS?

‘..make Australian research data collections more valuable by managing, connecting, enabling discovery and supporting the reuse of this data..’

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Manage data

Connect data

Find data

Reuse data

Resources

Research Data Australia(https://researchdata.ands.org.au/)

Guides (http://ands.org.au/guides)

Workshops, seminars, webinars

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What today’s all about

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Confessions of a sensitive soul

Image: CC-BY-SA Aaron Filler, MD, PhD

http://www.ands.org.au/datamanagement/sensitivedata.html

Getting on the same page

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Lets talk about data

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‘records, files or other evidence, irrespective of their content

or form (e.g. in print, digital, physical or other forms), that

comprise research observations, findings or outcomes,

including primary materials and analysed data’ (Monash University 2010)

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• Human data is data collected from or about individuals

• Health data includes information about their health (or others people’s health)

• Health data that is also sensitive – individual-levelhealth data (ie, not aggregated)

Publishing vs. Sharing

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Publishing = making data, or a

record about the data (metadata)

publically available

Sharing = giving others data

ARC

NHMRC

NHMRC Statement on Data Sharing ..encourages data sharing

New Human Research Ethics Application (HREA – replaces NEAF)

National Statement on Ethical Conduct in Human Research (s2 consent to future use)Australian Code for the Responsible Conduct of Research (s2 retain data)

Data sharing landscape

International funders

e.g. NIH, Wellcome

JOURNALS

e.g. BMJ & PLOS - all data underlying findings described must be fully available without restriction, with rare exception

The International Committee of Medical Journal Editors

‘..believes that there is an ethical obligation to responsibly share data

generated by interventional clinical trials because participants have put

themselves at risk.’

‘As a condition of consideration for publication of a clinical trial report in

our member journals, the ICMJE proposes to require authors to share

with others the deidentified individual-patient data (IPD) underlying the

results’

Institutional data policies

Federal and State policies Australian Government Public Data Policy Statement

‘..release non sensitive data as open by default; and to collaborate with the private and research sectors to extend the value of public data for the benefit of the Australian public..’

1. Increase citations

2. Expand network

3. Boost profile

4. Improve grant success

5. Efficiency

6. Ethics – participant

fatigue, getting needed

information out there

quickly

Image from: Eresearch SA

What makes health data sensitive?

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Personal (identifiable) information+ potential for harm or discrimination

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Privacy Act (1988, s6)

Personal information+ one or more of: health info, genetic, biometric,..politics

= Sensitive information

Legally: Privacy Law

Cannot be used beyond original purpose of collection without consent

Ethically

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‘any data that contain information that can be used to identify an individual and introduce a risk of discrimination, harm, or unwanted attention.’

http://www.ands.org.au/datamanagement/sensitivedata.html

Ethically

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• 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

Confidentialising data

‘confidentialisation', ‘de-identification', ‘anonymisation’

‘de-sensitising’

1. De-identifying - removing info that can identify person/s; and

2. Continuing to manage the risk of identification even after the dataset has been de-identified.

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Confidentialising data

1. Removing direct identifiers

2. Removing or altering other information that may allow an individual to be identified

E.g. unusual characteristics

Indirect identifiers (commonly, combinations of information)

http://ands.org.au/guides/sensitivedata

Hrynaszkiewicz et al. 2010 24

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Can my data be confidentialised?

Some data cannot be modified enough to adequately minimise the risk of identification without rendering the data invaluable.

Other options for publications? conditional/restricted access

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Depends on

• Whether its sensitive; how sensitive (identifiability/confidentiality)

• Participant consent• Ethics approval

How do I share health data?

Pre & during research planning

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1. Informed consent

2. Confidentialise/modify data if possible

3. Conditions to accessing data

4. Negotiate ownership & licencing of data

5. HREC Application

Curtin University now requires data

management plan in their HREC

application:

http://research.curtin.edu.au/research-integrity-

ethics/human-research-ethics/forms/

http://www.ands.org.au/datamanagement/sensitivedata.html

Publishing & Sharing

How?

If you have permission from participants & HREC

And (perhaps) confidentised data

Publish ‘openly’

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Or with conditions / restrictions

‘conditional access’

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What does this look like in the real world?

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http://www.alswh.org.au/

http://ands.org.au/working-with-

data/enabling-data-reuse/data-

reuse/benefiting-womens-health

Take away

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• It can be done in many cases!

• Be a scout: plan ahead

• Before publishing, ask about: participant consent? ethics approval (from all parties)? modify data first?

• (For later) Conditional access? Or a public and restricted version of data?

Resources

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• ANDS Guide to Publishing & Sharing Sensitive Datahttp://www.ands.org.au/datamanagement/sensitivedata.html- includes info on confidentialisation. See also Hrynaszkiewicz et al paper.

ANDS webinar recordings on ethics and sensitive data preparation https://www.youtube.com/playlist?list=PLG25fMbdLRa5pvodHMYDi3c0LTu8N3Ks-

• Website on Ethics and Best Practices in Sharing Individual-level Research Datahttps://bioethicsresearchreview.tghn.org/research-data-sharing/

• Digital data: Centre for Advancing Journalism and the Carlton Connect Initiative, Guidelines for the Ethical Use of Digital Data in Human Research http://carltonconnect.com.au/wp-content/uploads/2015/06/Ethical-Use-of-Digital-Data.pdf