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

ID: 
21
This submission reflects the views of
Organisation Name: 
Centre for Military and Veterans' Health
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’:: 
We support the definition as it is stated.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
We support the rationale provided for an opt-out approach as outlined in Section 3.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
We support the proposed limited application of an opt-out approach, in particular that a single research project may require a combination of approaches (Section 4.2). In the Defence research environment for instance: a study may be designed whereby explicit consent is required from the member to participate in a survey; a waiver may be requested for the use of already stored demographic data; and, an opt-out approach may be used to gain permission to contact a family member, such as a spouse. Explicit consent would then be used as normal for the spouse’s involvement.
4: Please comment on the flow chart (i.e. Section 4).: 
We support the layout and content of the flow chart at Section 4.
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.: 
We would find it useful to have clarification and/or confirmation of the approved methods of providing information to participants for the opt-out approach. For example, with our very mobile Defence population hard copy letter may not always be the most appropriate mechanism. We would appreciate consideration of the following approaches; leaving messages on answer machines, Email, SMS, or other electronic methods which may emerge in future. We also think it appropriate that information on opting-out should also be provided to participants on study web-sites and other study promotional materials.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
We support the proposed amendments to the National Statement.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
The CMVH cannot identify population specific situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
The CMVH cannot identify population specific situations where the draft amendments would allow an opt-out approach that may be inappropriate.
9. Can you provide examples where an opt-out approach may be useful?: 
It can be argued that the Defence population is over-researched group and the opt-out approach is one way that researchers can reduce the perceived burden of ‘contact fatigue’. In low risk, appropriate circumstances members can participate willingly without having to speak with the researchers or be continually ‘followed-up’ for consent.
General Comments
Comments: 

We have no general comments.

Page reviewed: 28 March, 2014