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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: 
ANZICS Clinical Trials Group
Please identify the best term to describe the Organisation: 
Clinical research organisation
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
see General Comments
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
see General Comments
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
see General Comments
4: Please comment on the flow chart (i.e. Section 4).: 
see General Comments
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.: 
see General Comments
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
see General Comments
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
see General Comments
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
see General Comments
9. Can you provide examples where an opt-out approach may be useful?: 
see General Comments
General Comments

The Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) wishes to make the following comments regarding the NHMRC Public Consultation on the Revision of the National Statement Chapter 2.3.


The ANZICS CTG is an investigator-led clinical trials network based in Australia and New Zealand. ANZICS CTG promotes excellence in Intensive Care medicine through collaborative clinical research. The ANZICS CTG has expertise in conducting ethically sound large-scale research where participants are highly dependent on medical care and often unable to give consent themselves. The group’s trials provide information to clinicians and policy-makers that is implemented into clinical practice. The group has randomised more than 30,000 patients and received competitive funding that exceeds $60 million. Implementation of the results of trials already conducted by the group has been estimated by the NHMRC to have the potential to save the Australian community in the order of $800 million per year, predominantly due to better outcomes for patients with severe traumatic brain injury.

1. Definition

We suggest that in an opt-out approach to research, the concept of “potential” participants is not correct, as all subjects are participating until they choose to opt out. We recommend that the word “potential” is removed.

2. Application of the new opt-out approach in research where adult participants are highly dependent on medical care

We recommend that the new provisions specifically acknowledge the suitability of opt-out approaches to consent in prospective participants who are highly dependent on medical care so long as the project satisfies all other requirements for the opt-out approach, and the requirements for ethical research in this population that are described in Chapter 4.4.

We recommend that if it is not practicable to approach the participant directly, then the guardian or person authorised by law is a suitable recipient for appropriate plain language information regarding the research and the option to opt-out (similar to the process described in 4.4.10).

3.     Application of the new opt-out approach in research which may commence without prior consent

This comment pertains to section 4.4.13 of the national statement but the application will influence interpretation of the revisions to chapter 2.3.

4.4.13 states that it is sometimes necessary and suitable for research to commence without prior consent in patients highly dependent on medical care. In such cases, participants or their relatives are informed as soon as reasonably possible. In situations where participants die from their illness prior to being informed (for reasons unrelated to the research), it is necessary to request permission from HREC that the requirement to provide information is waived. This is to avoid causing unnecessary distress to relatives.

We recommend that if a participant in an approved opt-out research project dies prior to them or their relatives receiving information, then it is appropriate for a HREC to waive this requirement to avoid causing distress to relatives.

4.     Applying the definition of low-and-negligible risk (LNR) research to comparative effectiveness research

This comment does not pertain specifically to patients highly dependent on medical care but comparisons of standard care interventions are common in ICU research.

This comment pertains to Chapter 2.1 of the national statement but is important to the new chapter 2.3 because the opt-out approach is suitable for low and negligible risk research only. The definition of LNR research will therefore attract increased attention from HRECs and investigators.

Low risk is defined in chapter 2.1 as research where the only foreseeable risk is one of discomfort and negligible risk where there is no more than inconvenience - no further information is provided to guide interpretation. It is not clear if ‘discomfort’ or ‘inconvenience’ applies in absolute or relative terms. In comparative effectiveness research, all participants receive one of two or more standard care interventions, all of which are already in common clinical use. Therefore there is zero additional discomfort, inconvenience or risk to participants compared to non-participants other than the use of data. This interpretation would mean that comparative effectiveness trials are potentially suitable for an opt-out approach to consent where it can be demonstrated that all participants will receive interventions that are common standard care.

By way of comparison, a single arm observational study of standard care would be of negligible risk, and comparative effective studies are essentially a randomised observation of two (or more) approaches to standard care.

We recommend that clarifying detail is added to the definition of LNR so that HREC can understand if projects meet the definition of ‘low or negligible risk’ and that this should be explicitly qualified to indicate that risk should be assessed in the context of the general risk for any particular patient from their health condition and its associated standard care treatment and that risk from administration of care that is already part of recognised standard care should be regarded as being of low risk.

It is the belief of the ANZICS CTG that these changes enhance protection of prospective participants who are highly dependent on medical care by providing clarity and facilitating the opportunity to participate in clinical trials that have been evaluated by an appropriately constituted HREC.  Such changes will also lead to an improved evidence base for the approximately 100,000 patients per year who are treated in Intensive Care Units in Australia and better utilisation of the $1 to 1.5 billion per year that is spent on direct provision of care to those patients.


Yours faithfully


[ONHMRC has removed personal information]
on behalf of the Executive Committee of the ANZICS CTG


Page reviewed: 28 March, 2014