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

Personal Details
First Name: 
SL Ezekiel
Last Name: 
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
I think that there are some situations where an opt-out approach is justifiable on patients who may be not be considered low/negligible risk. For example, any surgical caseload analysis of standard treatments would not be low risk due to the risks inherent with any surgery (though the risk is not higher than standard for the given population) though would be ideal for generating information with in an opt-out situation.
4: Please comment on the flow chart (i.e. Section 4).: 
Apart from the above, the flow chart is reasonable.
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.: 
The point of information delivery needs to be at a point to common to all participants who are anticipated to be included in the study. For example, in elective orthopaedics, this would best be done in the orthopaedic outpatient clinic waiting room or at the preoperative assessment area dependent on the population under assessment.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
I think these are well formulated.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
The National Statement often tends to assume an individual project. I think that the opt-out approach would be appropriate for not just single research questions but for whole academic department clinical research programs. For example, it would be useful to have posters in our clinic area stating: (1) You are being treated in an academic unit. (2) We analyze, present, and publish our treatment results in peer-reviewed forums worldwide. (3) Any information that we collect during your treatment relevant to that treatment may be used for research and quality improvement purposes. (4) You have the right not to have your data used for this purpose (opt-out forms at the front desk). (5) No personally identifiable information will be presented or published without explicit consent.
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?: 
Just about every clinical-outcomes based research will benefit from a well thought out opt-out approach to a clinical research program.
General Comments

I think that this review of Chapter 2.3 is important, especially for clinicians who work in the overlapping area between clinical research and clinical audit.  The draft guidelines are thoughtfully written and are welcome.

As a practicing orthopaedic surgeon, the only additional thing that I would like to see is that Ethics Committees give consideration to how much information the researchers or clinician/researchers already have access to for a group under study or audit compared to an external researcher.  The clinician researcher protects personal research data in the same way as they do personal data from the doctor-patient relationship and this is often not recognized by Ethics Comittee members.  I believe that we need to be encouraging more clinical research to be done and facilitating this for clinicians rather than tying it up in red tape.

Page reviewed: 28 March, 2014