Presentation by Jeremy Kenner from NHMRC on the review of the National Statement on Ethical Conduct in Human Research. Given on 9 May 2017 Full Webinar: https://www.youtube.com/watch?v=eENTF3oVVdk&t=2s Transcript: https://www.slideshare.net/AustralianNationalDataService/transcript-webinar9517healthandmedicalshortbites

1. Review of the National Statement on Ethical Conduct in
Human Research
ANDS Webinar
9 May 2017
Jeremy Kenner, Expert Advisor – Ethics
Evidence, Advice & Governance Branch
NHMRC

2. The National Statement
• Principles-based; mixture of high level guidance,
prescriptive guidance and best practice
• Four key principles, main issues (e.g. consent, risk),
research ‘category’ and population-based considerations,
establishment and operation of HRECs, institutional
responsibilities
• Applies to all human research, but only human research
• Has undergone full review (2004-06) and now subject to
ongoing review based on defined priorities

3. Guidance on data in the National Statement
• Two core objectives:
– For researchers to understand and minimise the risk of
unauthorised use or disclosure of sensitive personal information
obtained for use in research
– To ensure the appropriate collection, use and sharing of
data/information so as to maximise ethical use of the
data/information in research
• This requires:
– Principles to guide consideration of the ethical implications
– Pragmatic resolution of the tensions between the two core
objectives (i.e. to minimise risk and to maximise (ethical) use)

4. Guidance on data in the National Statement
• The National Statement provides
– The necessary framework of principles, including both ‘musts’ and
‘shoulds’ for researchers
– Prompts for consideration by reviewers re whether the proposed
mechanisms/processes
• Adequately protect participants
• Are ethically acceptable means of maximising use of data
• The National Statement does not provide
– Prescriptive direction regarding which mechanisms/processes to
use

5. Revision of the National Statement
• Section 3 (Ethical considerations specific to research
methods or fields) is in the final stages of revision
• Major changes in structure and content
– Elements of research
• Element 1 – Research Scope, Aims, Themes, Questions and Methods
• Element 2 – Recruitment
• Element 3 – Consent
• Element 4 – Data Collection and Management
• Element 5 – Communication of Research Findings or Results
• Element 6 – Dissemination of Research Outputs and Outcomes
• Element 7 – After the Project
• Guidance on ethical considerations related to use of data in
research in most elements.

6. HREA [https://hrea.gov.au/]
• A portal, inclusive of an application form, for facilitating
ethics review of all human research
• Scope:
– An ethics review application form plus submission system
– NOT a project management system or a database or an automatic
reporting system
– Potentially expandable to accommodate other needs of the
research sector
• *Section 3* - Questions related to data and privacy

7. ethics@nhmrc.gov.au
jeremy.kenner@nhmrc.gov.au
03 8866 0416