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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: 
Cancer Council Victoria HREC
Please identify the best term to describe the Organisation: 
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
No comment, this definition is fine.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
Table 1 - comparison of participant recruitment models is useful.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
no comment
4: Please comment on the flow chart (i.e. Section 4).: 
This is very good
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.: 
no comment
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
Overall we are in support of these amendments, however the wording of some of the clauses could be tightened up. In particular 2.2.10 c) and e). In 2.3.10 the following appears Before approving the use of an opt-out approach, an ethical review body must be satisfied that: .................. c) the data on outcomes generated by the activity is likely to be compromised if the participation rate is not near complete, and the requirement for explicit consent would compromise the necessary level of participation ............................... e) a mechanism for prospective participants to obtain further information and register their intention for non-participation is provided (where appropriate and practicable) Taken as a whole (that is, 2.3.10 as a whole) it would be fairly easy to satisfy the proposed opt out consent criteria in circumstances where there is low risk to the participant -- and that opting out might then become the default position for research ethics approval in such cases. We are not sure that just because it is low risk that that should be the default position -- there are possibly other values at play here. One way to tighten up and to avoid this default position might be to strengthen paragraph (c) above: "compromise" seems be a fairly weak test-- it would be easy to say/establish that the data is "compromised" and the requirement for explicit consent would "compromise" the level of participation. The Oxford dictionary defines compromise as: expediently accept standards that are lower than is desirable.. : - - Hence a researcher may easily establish the desirability of high participation rates etc. It may be that a stronger test is needed, such as saying 'significantly compromised" or "seriously compromised". Similarly in paragraph (e) - simply providing a mechanism etc may not be strong enough or prescriptive enough. Does that ensure adequate mechanisms and time for the opt out to be exercised? It is suggested that there may need to be more guidance as to exercising opt out --eg about time; manner etc. For example, giving someone information about the research and expecting fairly immediate exercising of the opt out in circumstances where it might be hard for the person to take that stand - eg, they are young; vulnerable at the time etc. Yet that would meet the criterion of having a mechanism for registering of intention for non-participation etc. There is some guidance provided in 2.3.11 but it could be expanded to provide more guidance. In other words, more attention needs to be given to the suitability of the mechanism and the appropriateness of the timing and method of opting out in 2.3.10. Perhaps the words: “a suitable mechanism which is proper in the circumstances for prospective participants” :-could be used. It is also suggested that the words "where appropriate and practicable" in brackets at the end of paragraph (e) weaken the effect of this criterion too much and should be deleted.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
no comment
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
no comment
9. Can you provide examples where an opt-out approach may be useful?: 
no comment
General Comments


Page reviewed: 28 March, 2014