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

ID: 
10
Personal Details
First Name: 
Jennifer
Last Name: 
Lethlean
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
I support this definition
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
I think the rationale is clear and providing an opt-out option will benefit clinical researchers in situations where data has been collected as part of routine clinical practice where the research benefit is determined retrospectively.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
This proposed limited application of an opt-out approach is clearly outlined and reasonable.
4: Please comment on the flow chart (i.e. Section 4).: 
The flow-chart is a very helpful tool. It may be helpful to also have links from this flow chart to the NEAF and or HREC webpages for 3a and 6a and links to the NHMRC webpage documents determining whether or not your project fits into the low/negligible risk category and NEAF for low risk projects for 3b and 6d.
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.: 
I'm assuming this refers to 4.4 of the document and the reference to the Privacy Act. I'm not sure this actually is a mechanism to provide information to participants. Perhaps this needs to be made more explicit with a cut and paste paragraph that explains this which could be inserted into a patient information form with the "opt out" option.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
The proposed amendments look reasonable.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
Not to my knowledge.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
Not to my knowledge.
9. Can you provide examples where an opt-out approach may be useful?: 
Use of pre and post rehabilitation therapy outcomes data collected as part of routine practice where research use was not anticipated and a change in model of care and/or clinical practice needs to be evaluated. Retrospective chart research audits for publication.

Page reviewed: 28 March, 2014