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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: 
RMIT University
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
The definition is adequate and would be, generally, understood by the research community.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The RMIT HREC does not currently allow researchers to employ an opt-out approach, because it was believed to be excluded by the National Statement. We believe that some researchers would like, in certain circumstances, to employ this approach. Researchers and the HREC would agree with the rationale provided.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
The proposed opt-out approach is limited to specific circumstances that will require approval by a HREC. This is appropriate.
4: Please comment on the flow chart (i.e. Section 4).: 
The flow chart illustrates the opt-out approach appropriately.
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.: 
Information should be provided in writing and/or via mail, email or electronic means
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
No comment
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
We are not aware of any.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
We are not aware of any such situations.
9. Can you provide examples where an opt-out approach may be useful?: 
No specific examples.
General Comments

The proposed amendments will help to clarify the circumstances under which the opt-out approach will be appropriate and provides clear instructions to ethics committees and reseachers about how to review such requests. 

Page reviewed: 28 March, 2014