Presentation from Dr Conor Brophy, MBBS, MD, MBioethics, FRCP, AFRACMA, Chair of Mater Misericordiae Ltd Human Research Ethics Committee, Adjunct Professor, QUT Chairperson UHREC. Dr Brophy addressed planning for data sharing in research ethics applications. Webinar: https://youtu.be/MIaSA-4z2PI Full Webinar: https://youtu.be/FSlA1noJ1VU

1. Conor Brophy
Chair, Human Research Ethics Committee, Queensland University of Technology
Adjunct Professor, QUT.
Chairperson, Human Research Ethics Committee, Mater Misericordiae Ltd,
Queensland
Senior Lecturer, School of Medicine, University of Queensland

2. The primary principle guiding ethical review of research is utilitarian. The
ethical premise is that:
 Research is a ‘good’ which can and should be maximised for public benefit.
This also applies to data sourced and used in research.
The primary principle - the value of research - is balanced with others
focused on the individual i.e. justice, beneficence and respect:
 maximising benefit for participants; minimising risks and burdens
 engagement, information for and consent of individual participants
 maintaining privacy and ensuring confidentiality of elements of data which could
lead to identification
 while ensuring the efficient use of research effort and funding

3.  NHMRC National Statement on Ethical Conduct in Human
Research (2007)
https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_nation
al_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/r39_australi
an_code_responsible_conduct_research_150107.pdf
 NHMRC Statement on Data Sharing (2015)
https://www.nhmrc.gov.au/grants-funding/policy/nhmrc-statement-data-
sharing
 Consumer Guide to the Principles for Accessing and Using
Publicly Funded Data for Health Research
 https://www.nhmrc.gov.au/_files_nhmrc/file/research/data_accessconsumer_g
uide_accessible.pdf

4.  Principles for Accessing and Using Publicly Funded Data for
Health Research (2016) 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

5.  NHMRC supports data sharing and public access to data and outputs
from NHMRC-supported research.*
 The public and participants are advised^ that:
‘…use of these data for research …..provides our greatest opportunity to unlock
the value in these records for the benefit all Australians …
 The quid pro quo is:
data are ‘collected subject to privacy and confidentiality conditions, …use of these
data …will maintain these requirements
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/grants-funding/policy/nhmrc-statement-data-sharing*
https://www.nhmrc.gov.au/_files_nhmrc/file/research/data_accessconsumer_guide_accessi
ble.pdf^

6.  To promote data sharing and use.
 To maintain trust in research endeavours.
 That participant’s interests are served.
 The perspective of a participant is represented.
 Research is facilitated and achieves its ends.
 That conclusions can be confirmed, data reused and benefit
maximised.
 Stakeholders indicate that they understand and will follow best
practice guidelines.

7.  Any research study in which data are collected or used again in
the future demonstrates sufficient quality – research merit* (NS
1.1a,b,c)
 Responsibilities are passed on with the data. (*NS 3.2.3, 3.2.5, 3.2.12)
 A new project using already collected research data has
consistent closely related aims or there is provision for seeking
further consent. (*NS 2.2.14b; 3.2.9b, 3.2.11)
 Respect* for autonomy, expectation of quality and any prior
agreements are demonstrated:
◦ consent – nature and quality in the original study is sufficient for likely further
aims (*NS 2.2.14-18; 3.2.3) …or
◦ intend to return to participants to notify or seek consent (*NS 2.2.8)
*https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_statement_ma
y_2015_150514_a.pdf

8. Justice, beneficence and respect*
 The population from which the research cohort is drawn will
benefit through generaliseable knowledge or application of
findings. (*NS 1.4d,f; 1.6)
 Any implications from the research for participants and
others are acted upon, e.g. returning study findings;
addressing potential harms and benefits. (*NS 1.4d,f; 1.5; 3.2.6)
 The research has robust controls, governance, and
agreements regarding access, use and release of data; i.e.
confidentiality and privacy undertakings. (*NS 1.12; 3.2.12)
*https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_stateme
nt_may_2015_150514_a.pdf

9.  International and national guidance is consistent in supporting
research data sharing and reuse.
 Research studies must satisfy quality standards.
 Plan to maximise the benefit of the research including future
use of research data.
 Define these future possibilities, privacy and confidentiality
standards in submitted papers (protocols, agreements, information).
 Ensure participants are well informed about current and future
research, and are given options for consent to each.
 Use of research data must comply with prior consent and
agreements unless these are renegotiated.