Kate LeMay

Ethics and consent for data sharing

Senior Research Data Specialist

28 October 2016

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

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 (access)

Confidentialised data is no longer sensitive and can be shared

Informed consent

1. Avoid precluding data confidentialisation, publication and sharing

2. State possibility of future data publication3. State conditions of access4. 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

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 datahttp://arep.med.harvard.edu/pdf/Lunshof08.pdfhttp://lsspjournal.springeropen.com/articles/10.1186/s40504-014-0020-9http://genomesunzipped.org/2010/10/why-public-genomics-is-not-a-purely-personal-decision.php#more-1186

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 data is not always the same as open access

ands.org.au/medical

ands.org.au/medicalthings

Senior Research Data Specialistkate.lemay@ands.org.auands.org.au/medical

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.