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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: 
Stroke Society of Australasia
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
This is appropriate, however, would be improved by addition of the words ‘or their person responsible’ or similar terminology to encompass information provision to the next of kin or carer as follows: ‘where information has been provided to the potential participant or their person responsible regarding …’ Furthermore, addition of the words ‘or clinical registries’ would be useful ie ‘recruitment of participants into research and clinical registries’.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The rationale is appropriate and extremely relevant. Opt off consent should apply to all disease registries and health services research examining organisation of care. This is applicable in those situations where follow-up of patients is required requiring collection of identifiable data.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
This statement should explicitly state that all registries should use opt off consent as the gold standard. Point 4.1 is valid but it is not clear in regard to what the criteria are and who is making this decision about merit and integrity. It may not be appropriate for all HRECs to provide this level of advice as they may not have the level of expertise and some would consider it is not their role.
4: Please comment on the flow chart (i.e. Section 4).: 
Flowchart is clear but if there is an option for waiver of consent in 6b following identification of value of data for research (5a) then this should also appear under 2a (ie add in waiver of consent under 2a) to match. Furthermore, this would be highly appropriate for research studies that subsequently wish to follow-up patients over a longer period of time. Under 3b – add in explicitly that this includes clinical registries in regard to opt-off consent.
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 would require the participant/ next of kin/ person responsible to be given a participant information statement as per usual recruiting process for studies.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
These are appropriate and clear. They require a point about opt off consent for clinical registries and not just where the registry is deemed low risk. All clinical registries regardless of risk (ie those storing identifiable data) should use opt off consent and the appropriateness of this should be more explicit in the statement amendments to guide HRECs.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
A strength of these changes are that the characteristics of research are described rather than a strictly delineated list of categories. This gives HRECs the ability to judge this suitability on a case-by-case basis.
8. Are there any situations you can think of 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?: 
1. Clinical registries 2. Studies involving collection of data for quality assurance purposes ie audit of clinical practice. In these instances this would be extremly beneficial. 3. It could also be useful in studies that recruit patients with particular conditions such as stroke. It is often difficult to recruit patients with severe stroke to studies resulting in research that is only generalisable to mild or moderate strokes. For low risk research that wishes to under-take medical record audits but still use identifiable data, an opt-out approach would make results from studies like these more scientifically valid due to an improved response rate.
General Comments

This is a laudable initiative and long overdue. Opt-out consent will increase the scientific validity of research.  It likely also will speed up patient recruitment and enable studies to finish in a timely manner as recruiting patients to studies, particularly in stroke, is notoriously difficult.  This, in turn, will enable more research to be undertaken as studies are completed faster than occur at present.

Page reviewed: 28 March, 2014