Presentation given by Conor Brophy at the 'Sharing Health-y Data Workshop: Challenges and Solutions' event co-hosted by ANDS and HISA. Held on Wednesday 16th March 2016 at the Translational Research Institute, Brisbane, Australia.

1. Conor Brophy
Chairperson, Human Research Ethics Committee, RBWH, Metro North HHS
Chairperson, Human Research Ethics Committee, Mater Health Service
Senior Lecturer, School of Medicine, UQ

2. }NHMRC National Statement on Ethical Conduct in
Human Research (2007)
https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e7
2_national_statement_may_2015_150514_a.pdf
}NHMRC Australian Code for the Responsible
Conduct of Research (2007)
https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/r3
9_australian_code_responsible_conduct_research_150107.pdf
}NHMRC Statement on Data Sharing (2015)
https://www.nhmrc.gov.au/grants-funding/policy/nhmrc-statement-
data-sharing

3. }Principles for Accessing and Using Publicly Funded
Data for Health Research
https://www.nhmrc.gov.au/principles-accessing-and-using-publicly-
funded-data-health-research
}Global Alliance for Genomics and Health - REWG
https://genomicsandhealth.org/node/12703
}International Cancer Genome Consortium
https://icgc.org/icgc/goals-structure-policies-guidelines
}Wellcome Trust http://www.wellcome.ac.uk/About-
us/Policy/Spotlight-issues/Data-sharing/Public-health-and-
epidemiology/WTDV030690.htm

4. As with all research, the primary principle guiding
sharing of research data is utilitarian:
} to maximise public good
} to make best use of research effort and funding.
The primary principle can only be realised in concert
with other principles of justice, beneficence and respect
} sharing is dependent on maintaining privacy and confidentiality of
data and
} with the informed consent of the individual

5. } Data and research outputs (metadata, analysis code, study
protocols, study materials and other collected data) from
NHMRC-supported research should be publicly accessible.
} Aligns with researchers’ and institutions’ responsibilities under
other NHMRC guidance: the National Statement and the Code.
} Consumers told:
‘Publicly funded data holdings …collected subject to privacy and confidentiality
conditions, …use of these data for research will maintain these requirements and
not significantly increase the risk to privacy and confidentiality and
Researchers receiving access to publicly funded data are subject to strict ethics
approval processes. …that the research project is worthwhile and will add to
important knowledge about the health of Australians…’
https://www.nhmrc.gov.au/_files_nhmrc/file/research/data_accessconsumer_gu
ide_accessible.pdf

6. } Trust in ‘research’ and the process promised can be maintained.
} Any research study for which data will be supplied is of sufficient
quality – research merit* (NS 1.1a,b,c)
} A new project has consistent closely related aims… and/or
} Consistent with respect* for autonomy:
◦ Consent – nature and quality in the original study is sufficient for the further
aims (*NS 2.2.14-18; 3.2.3) …or
◦ Return to participants to notify or seek consent (*NS 2.2.8)
*https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_st
atement_may_2015_150514_a.pdf

7. Justice, beneficence and respect*
} Robust controls, governance, agreements regarding access,
release, and use of data; i.e. confidentiality and privacy
undertakings are fulfilled. (*NS 1.12; 3.2.12)
} Any implications from the research for participants and
others are acted upon, including return of study findings,
potential harms and benefits. (*NS 1.4d,f; 1.5; 3.2.6)
*https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_natio
nal_statement_may_2015_150514_a.pdf

8. } That participant’s interests are served
} The perspective of a participant is represented
} Stakeholders indicate that they understand and will
follow best practice guidelines
} Research is facilitated and achieves its ends

9. Thank you
© State of Queensland (Queensland Health) 2016
http://creativecommons.org/licenses/by/3.0/au/deed.en