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Section 3 (Chapters 3.1 & 3.5), Glossary and Revisions to Section 5 National Statement on Ethical Conduct in Human Research, 2007 submission

ID: 
53
This submission reflects the views of
Organisation Name: 
Behavioural Economics Team of the Australian Government
Personal Details
Specific Comments
Comments: 
1. Introduction to Section 3

BETA endorses the introduction of Chapter 3.1

2. Chapter 3.1

BETA broadly endorses the introduction of Chapter 3.1, and the approach taken to combine Chapters 3.1, 3.2 and 3.3 with additional material and the relocation of some material from Chapter 3.3 into Section 5.

Specific comments on proposed clauses are:

  • 3.1.1 Propose adding the sub-clause: ‘how the methods and design of the project are appropriate and adequate to explore the research questions’.

  • 3.1.11 Propose re-wording the clause to read: ‘Research proposals should clearly describe the recruitment strategy, and the process and criteria for selecting participants (sampling strategy)’.

  • 3.1.38 We note that the revisions have removed the term ‘de-identified data’, and requested researchers use ‘non-identifiable’ or ‘re-identifiable’ data, depending on the context, in its place. We understand the somewhat ambiguous use of the term ‘de-identified data’, however, we believe it is advisable that the National Statement endorse language that is consistent with privacy legislation. Including inconsistent terminology in relation to data identifiability may have the perverse effect of increasing confusion in the research community. Instead, we propose the National Statement provide more guidance to researchers on what constitutes ‘identified data’, ‘potentially identifiable data’ and de-identified data’. 

4. Section 5

BETA strongly supports the revisions to Section 5, in particular with regard to the removal of ‘Chapter 3.3: Interventions and therapies, including clinical and non-clinical trials, and innovations’ from 5.1.6 (b). It is our view that institutions should be permitted to establish other levels of ethical review for non-clinical trials that are assessed as carrying negligible or low risk.

The proposed streamlined approach will support BETA to run trials more expeditiously, and in turn, to achieve timely research outcomes for government.  

There is an increasing focus on policy and program evaluation in the Australian Public Service, in addition to an increasing appreciation for the use of randomised control trials as the gold standard for building evidence to support government policy. As such, BETA expects a growing number of government departments will conduct non-clinical trials as a policy and program evaluation methodology.

It is in the NHMRC’s interests to facilitate the conduct of non-clinical trials across government with an ethical yet streamlined approach.

 

5. Glossary

BETA suggests that the definition of ‘Intervention’ (p. 37) be broadened to encompass behavioural interventions and any policy change, rather than be restricted to education or social policy.

Supporting attachments
Supporting attachments: 

Page reviewed: 10 July, 2018