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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: 
Victoria University HREC
Please identify the best term to describe the Organisation: 
Ethics / bioethics organisation
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
The definition of opt out is comprehensive. What is missing is a check for understanding that is commonly used when explicit consent is employed. How are researchers to know that those involved in the study have read or understood the protocol? In particular, how do we know that people from CALD communities have a good understanding?
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The rationale used for increasing the op out approach in large observational studies is scientifically important, and based on the principle of increasing public benefit. However, it does not try and address the issue as to why so few people choose to be in such research projects. The assumption seems to be general disinterest. However, without further research, it is not clear that this is in fact the case. Before this assumption can be made, it is important that more research be undertaken to explain such low rates of participation.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
This seems comprehensive.
4: Please comment on the flow chart (i.e. Section 4).: 
The mechanism for opt out following 2b is unclear. Will participants be contacted after the data is collected and given the opportunity to opt out at that point?
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.: 
Participants should be sent an information form that sets out the research proposal, and an explanation as to why this was not done when the data was collected. They should have the opportunity to ask for more information from the HREC or the researchers’ concerned, and be given a period of time to register their decision to opt out, via email or through a website.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
2.3.10 point e This should be standard procedure, and therefore the words “where appropriate and practicable” should be deleted.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
We have no comment to make here.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
It is important to consider that research into stigmatising conditions, or with populations that may be stigmatised as a collective might be undertaken using the “opt out” conditions here. While individuals may not be able to be identified, further stigma might accrue to these populations. In this case “opt out” may not be an adequate form of informed consent.
9. Can you provide examples where an opt-out approach may be useful?: 
“Opt out” is most appropriate when we can be sure that participants are fully informed about the studies they are engaged in. Therefore, a study that utilises both “opt in” and “opt out” for different aspects of the study seems to ensure that accurate information will be given and more fundamentally, that participants understand thoroughly the nature of the study.
General Comments

Informed consent is the cornerstone of ethical research practice. As such, any attempt to relax the mechanisms that ensure informed consent must be considered with great care. The proposed changes to Chapter 2.3.1 of the National Statement focus on situations where an “opt out” process or a waiver of consent might take the place of a more specific process.

While HRECs throughout Australia provide a rigorous and protective check on research, it is important to remember that very few people actually know of their existence, or what it is that they do. Therefore, it is problematic to suggest that HRECs can speak for participants, or accurately represent their interests when the final step, explicit informed consent, is not undertaken. What they can, and indeed do, is ensure that research protocols are compliant with the National Statement, and sensitive to local conditions. However, the two things are not the same.

Within the committee two views were expressed concerning “opt out” or waiver of consent when research was anything other than low risk. One was that emergency research was important, and that if explicit consent could not be obtained, such important research could not be done, and this would not benefit the public good. An opposing view was also expressed, namely, that such research, involving a “high risk” setting, must always be undertaken on the basis of explicit informed consent.

Underlying the idea that we can relax explicit informed consent, is the assumption that research is both being done for the public good, and that it is so understood by the general public. Both these assumptions need to be demonstrated with further evidence.  It is unclear that many members of the general public understand the mechanisms of research, or its outcomes. While the mechanisms suggested here go a long way to protect the general public’s privacy, there are issues related to the  social contract that are protected by explicit consent that need further discussion.

Page reviewed: 28 March, 2014