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Review of Chapter 2.3 of the National Statement: Qualifying or waiving conditions for consent submission

This submission reflects the views of
Organisation Name: 
Swinburne University of Technology
Please identify the best term to describe the Organisation: 
Educational institution – tertiary
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
The definition seems fine for what is proposed(but we note that the definition pertains to information to be collected, not to data already collected for which an opt-out approach may also be appropriate).
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The rationale as outlined focuses on medical/health research and perhaps should have also addressed other human research.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
Again, the focus, eg, 4.4, is on medical and health research and yet the National Statement applies to all human research. It would also be helpful to make reference to a test of impracticability as allowed for in some Privacy legislation and its appropriate use.
4: Please comment on the flow chart (i.e. Section 4).: 
This seems fine.
5. Please comment on the appropriate mechanism for providing information to participants for the opt-out approach represented at box 6d of the flow chart.: 
This seems fine.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
2.3.9: if a public interest determination is to be made, perhaps it's better for an HREC to make the determination rather than another type of ethical review body. 2.3.10: overall, the effect may be too prescriptive and focussed on compliance, we suggest that "must" be changed to "should" as given at 2.3.11. The text at the start of 2.3.10 might be better put as "Before approving the use of an opt-out approach, an ethical review body should be satisfied as to some or more of the following (as appropriate):" The word "must" suggests or requires all of the following sub-points to be implemented where perhaps not all may be needed or relevant. We believe good judgement can be relied upon from those working to the National Statement's values and guidelines, but note our earlier point about an HREC being best placed to make a public interest determination versus any other type of determination. b) suggest change to "the proposed activity has sufficient (or demonstrable) merit and is likely to prove beneficial". Reference to "public benefit" might invoke too high a standard when the benefit might have more restricted or local benefit, eg, only pertaining to a particular cohort or context. c) this sub-point is perhaps too specific and may not be needed, application of the National Statement principles and values, eg, research merit and integrity, should be enough. d) fine as is. e) fine as is, noting particularly the use of the phrase "appropriate and practicable"; this phrase might also be useful elsewhere in this section. f) fine as is. g) minor stylistic correction: "data are involved". h) better to omit "technical" unless a definition is given; or else refer to "appropriate or applicable standards". i) "governance process" might also need defintion; would it be better to refer to "responsible management"? 2.3.11: the word "should" is appropriate and, as referred to above, replace "must" with "should" at 2.3.10.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
Note our earlier point about the rationale covering medical and health research. Other situations: research into teaching and learning, research on service provision. Research involving schools and pupils (but subject to any applicable Education authority requirements and standards.) But what of data already collected for which an opt-out approach may be appropriate?
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
There may be but good use of the National Statement should minimise inappropriate use of the opt-out option.
9. Can you provide examples where an opt-out approach may be useful?: 
See above at 7.
General Comments


For universities which conduct much human research which is neither medical nor health research, a concern remains that revisions of the National Statement appear to be driven by or focus on medical and health research.

Given our comments about the new proposed Opt-out approach, 2.3.9 to 2.3.11, a concern also remains about the effect of prescription rather than guidance and perhaps of an undue emphasis on compliance; care thus needed with use of "musts" and "shoulds".



Page reviewed: 28 March, 2014