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

ID: 
45
This submission reflects the views of
Organisation Name: 
School of Psychology and Speech Pathology, Curtin University
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’:: 
Yes this is clear.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
A fair and sound rationale. Adequate recruitment and representation is essential in order to generalise findings.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
It is best to proceed cautiously.
4: Please comment on the flow chart (i.e. Section 4).: 
This is clear and comprehensive.
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.: 
In order for the opt-out approach to be effective, there must exist a simple and clear process for prospective participants to indicate their wish not to proceed. Participants may not declare their wishes if the process for opting-out is unclear or complex, and we feel this should be addressed explicitly. The processes outlined could be clearer.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
The School of Psychology and Speech Pathology, Curtin University, supports the proposed revisions to Chapter 2.3 ‘Qualifying or waiving conditions for consent’ of the National Statement on Ethical Conduct in Human Research (2007) that allow an opt-out approach to participant recruitment in low and negligible risk research. One caveat to our support is that, in order for the opt-out approach to be effective, there must exist a simple and clear process for prospective participants to indicate their wish not to proceed. Participants may not declare their wishes if the process for opting-out is unclear or complex, and we feel this should be addressed explicitly. This may be particularly pertinent in group situations where there may be a perception of coercion or pressure to participate.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
The School of Psychology and Speech Pathology, Curtin University, would also support an opt-out approach in instances where opting-in may be particularly onerous and a simple opt-out could be provided, such as in the case of clients of community agencies. This would balance the need for potential participants to be able to decline with the ethical imperative for people to be given opportunities for involvement in research.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
One caveat to our support is that, in order for the opt-out approach to be effective, there must exist a simple and clear process for prospective participants to indicate their wish not to proceed. Participants may not declare their wishes if the process for opting-out is unclear or complex, and we feel this should be addressed explicitly. This may be particularly pertinent in group situations where there may be a perception of coercion or pressure to participate.
9. Can you provide examples where an opt-out approach may be useful?: 
School where parents have many letters and notes to read; community agencies with clients; University students; members of professioanl bodies.

Page reviewed: 28 March, 2014