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

Personal Details
First Name: 
Last Name: 
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
Thank you for the opportunity to comment. My comments are below. An adequate definition is provided.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The rationale provided for an opt-out approach is limited. It is based on arguments calling for the primacy of research over other considerations. This can be seen in the phrases used. For example, in paragraph 3.2 the “integrity of the research may be compromised”, and in paragraph 3.3 “diminished credibility of the data”. While this is not the focus of this public discussion, the research arguments presented in the rationale provided are debatable. Two issues are briefly mentioned here: (1) Achieving a response rate of 100% for low risk / negligible risk research using surveys or questionnaires is extremely rare. Using this rate as the benchmark is unrealistic. (2) In terms of obtaining research participant consent, there is a qualitative difference between clinical registries in the area of trauma (e.g. orthopaedic and neurological) and clinical registries for other health conditions. This difference affects research study recruitment rates. In the trauma area, the rapid onset of the injury / condition and the need for urgent medical intervention, as well as the possibility of impaired cognition, prevent the opportunity to seek research participant consent from the individual patient prior to treatment. This is not the case in other health conditions (for example, cancer and arthritis) where research participant consent can be discussed with the individual patient prior to treatment. The rationale provided does not consider issues related to research participant consent and autonomy. This goes against the following statement in the general requirements for consent (Chapter 2.2, National Statement on Ethical Conduct in Human Research 2007 [Updated May 2013], page 19). “Variations of these conditions may be ethically justified for some research. Respect for human beings must, however, always be shown in any alternative arrangements for deciding whether potential participants are to enter the research.” Reference: National Statement on Ethical Conduct in Human Research 2007 (Updated May 2013).The National Health and Medical Research Council, the Australian Research Council and the Australian Vice-Chancellors’ Committee. Canberra.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
An adequate outline of the issues for ethical review is provided here.
4: Please comment on the flow chart (i.e. Section 4).: 
Issue 1 – The flowchart describes an unrealistic situation from Box 2B on “Data use for research is not anticipated”. Most data collections can be used for research purposes. In this context, I note, that the Australian Law Reform Commission in 2008 recommended an amendment to the Privacy Act to define ‘research’ to include the compilation or the analysis of statistics (See ALRC 108 [Final Report], May 2008, Recommendation 65-3, page 2169). Issue 2 – In relation to Box 6D (the opt-out approach) the flowchart does not make sense, as the identifiable data has already been collected at Box 4B. In other words, the opt-out approach, as described, can not apply here as it is after the event. Data collection has already occurred. If identifiable data is already collected and subsequently used for research purposes, it does require ethical review. In this situation, why is the waiver option (Box 6B) not followed? Reference: Australian Law Reform Commission (2008) Australian Privacy Law and Practice. ALRC 108 (Final Report). Australian Law Reform Commission. Sydney.
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.: 
An appropriate mechanism for providing information cannot be described because of the temporal problem outlined above.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
As the opt-out approach needs to be assessed against the ethical principle of respect (especially research participant autonomy) and modifies the general requirements for consent, the proposed amendments should mirror the wording used for the waiver option (2.3.5 - 2.36, 2.3.8). For example, “Only an HREC may grant an opt-out approach for consent for research using personal information in medical research, or personal health information.” Wording the proposed amendments in this way gives greater emphasis on the importance of ethical review when the general requirements of consent are altered in a particular research study. Following this proposed method means that draft clauses 2.3.9 to 2.3.11 need to be rewritten.
7. Are there 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?: 
Yes, there are situations where the draft amendments may be inappropriate. These draft rules can be used by researchers and research organisations to collect identifiable patient data and develop research databases without participant consent (see for example the wording of draft clause 2.3.10. part G). Advocates of the opt-out approach talk of the development of a “data spine” for research purposes (Evans, Loff and Cameron, 2013) which could be linked to other data collections. With this in mind, in the context of low risk / negligible risk research, a visit to a health service provider or the completion of a simple office form or short questionnaire would be regarded as agreeing to be a part of the larger database / research study. In the absence of a consent procedure the patient may not be aware that this has occurred. Their identifiable patient data would then be used for research purposes without their knowledge. If this is discovered by the patient (for example, with a follow-up phone call or letter, or during another health provider visit), after the event, the patient may not want to participate in the research. The normal research partnership based on consent between the researcher and the research participant would not be in place due to the lack of information and the absence of personal decision making / autonomy. From a research point of view, the concern with the opt-out approach is when a research participant discovers their involvement in a research project and is unhappy about this situation. These patients may then be unwilling to participate (i.e. consent) to other types of research studies in the future (this includes participating in survey research). For these reasons, ethical review is required for the opt-out approach as the general requirements of consent are altered. This ethical review should be similar to the requirements for the waiver option. Reference: Evans, Loff and Cameron (2013) Clinical registries: the urgent need to address ethical hurdles. Medical Journal of Australia. Volume 198, pages 134 - 135.  
9. Can you provide examples where an opt-out approach may be useful?: 
General Comments

Finally on a related matter, it seems that over time the difference between low risk / negligible risk research and other types of research (i.e. higher risk) is becoming an important demarcation line. The developers of the National Statement on Ethical Conduct in Human Research could give researchers further advice in this area by describing the types of research activity that may be categorised as low risk / negligible risk.

Page reviewed: 28 March, 2014