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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: 
Association of Australian Medical Research Institutes
Please identify the best term to describe the Organisation: 
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
AAMRI supports the proposed definition of ‘opt-out’.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
AAMRI agrees with the rationale provided for the opt-out approach. As acknowledged in the consultation paper, seeking explicit consent from research participants can result in insufficient participant numbers and/or biased results in some circumstances, impacting scientific rigour, research validity, and, ultimately, the public benefit of research. Adding to the evidence provided in the consultation paper, research from the University of Adelaide – "A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage" (2012) – also found that the opt-out approach resulted in higher participation rates and a more representative sample that the opt-in approach.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
AAMRI has no concerns with the proposed limited application of an opt-out approach.
4: Please comment on the flow chart (i.e. Section 4).: 
AAMRI has several concerns with the flow chart. Currently, the method of participant recruitment, the requirement or otherwise for HREC/ethical approval, and the level of risk of research are merged together (i.e. boxes 3a-3c and 6a-6c). This causes some confusion. For example, according to box 3a, it would appear that for a low risk medical research project using explicit consent for recruitment, no ethical review is required (as the requirement for review by a non-HREC ethical review panel is not explicitly stated in the flow chart). We suggest separating out these levels of decision making / process, or, at a minimum, being more explicit about requirements for non-HREC ethical review panel approval. Regarding box 3b (Opt-out approach), the flow chart would suggest that there is no requirement for HREC approval for medical research that uses identifiable personal information. This is inconsistent with Table 1, which proposes that HREC approval be required for medical research that recruits participants using the opt-out approach and uses identifiable personal information (and that non-HREC review be required in other cases where the opt-out approach is used). We notice that the proposed requirement for HREC approval for the opt-out approach for medical research using identifiable personal information is also missing from amendments to the National Statement at Appendix A. This should be clarified. Box 6b (Waiver, HREC approval for more than low risk or if s95 or s95A apply), appears to be inconsistent with the National Statement (clause 2.3.6a), where it states that an HREC or other review body cannot provide approval for more than low risk research. Finally, the flow chart appears to be missing the ‘limited disclosure’ option for participant recruitment set out in the National Statement.
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.: 
AAMRI member feedback on this question was mixed. Some members felt it appropriate to use the opt-out approach of participant recruitment retrospective to data collection if patients were contacted (for example, by mail). Others considered the opt-out approach inappropriate after collection of data had taken place, considering a waiver of consent the appropriate approach. This would particularly be the case for very large population health or administrative datasets, where it would simply not be practicable to contact participants.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
As noted in the answer to Question 4, Table 1 of the consultation paper proposes that approval from an HREC be required for the opt-out approach if the research project uses identifiable personal information. We suggest that this be reflected in amendments to the National Statement, perhaps by including a clause similar to clause 2.3.5, (e.g. “Only an HREC may grant use of the opt-out approach for research using identifiable personal information. Other review bodies may grant use of the opt-out approach for other research.”). Clause 2.3.9 of the proposed amendments is unnecessary, as it already appears at clause 5.1.7 of the National Statement. This clause isn’t re-stated under the ‘limited disclosure’ or ‘waiver’ sections of the National Statement, for example, which also refer to other review bodies. Regarding clause 2.3.10c – "Before approving the use of an opt-out approach, an ethical review body must be satisfied that: the data on outcomes generated by the activity is likely to be compromised if the participation rate is not near complete, and the requirement for explicit consent would compromise the necessary level of participation" – AAMRI agrees that the opt-out approach is particularly relevant for research where near complete participation rates are essential, and where the degree to which a study falls short of complete participation is the degree to which the sample is biased. However, consideration could also perhaps be given to low risk research where an opt-out approach is appropriate for reasons other than the need for ‘near complete’ participation rates (see Question 7).
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
It is possible that there may be cases of low risk research where an opt-out approach is appropriate for reasons other than the need for near complete participation rates. For example, an AAMRI member suggested that the opt-out approach might be appropriate for non-therapeutic clinical trials where the full informed consent approach may be burdensome enough to reduce participation rate to a point where it is too low to be useful, whereas an opt-out approach may collect a more representative sample.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
There could be research that uses identifiable personal information where research findings have a health consequence for the research participant and their family. In such cases, if an opt-out approach is used, there should be provisions to determine whether notification of participants is necessary or justified.
9. Can you provide examples where an opt-out approach may be useful?: 
Including opt-out consent provisions within the National Statement would particularly benefit large, low risk epidemiological studies, as well as research using pre-collected health or other data. The opt-out consent approach would also benefit low risk research involving self-report questionnaires. The Australian Secondary School Alcohol and Drug Survey (ASSAD), for example, has successfully utilised opt-out consent for 20 years without incident, providing crucial data for public health and education services. In contrast, it is understood that similar surveys using explicit consent have had poor response rates, impacting the validity of findings.
General Comments

There is broad support from AAMRI’s members for the inclusion of provisions in the National Statement for opt-out consent of research participants.


Page reviewed: 28 March, 2014