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

ID: 
18
This submission reflects the views of
Organisation Name: 
Deakin University
Please identify the best term to describe the Organisation: 
Educational institution – tertiary
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
Added words in capitals, deleted words in square brackets: A method used in the recruitment of participants into research where information has been provided to the potential participant regarding BOTH the [activity] RESEARCH and their involvement in IT; [which] AND WHERE their participation is presumed unless they take action to decline to participate.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The rationale for opt-out consent in certain kinds of studies where a close to complete data set is required is appropriate, where the risk to participants is low or negligible.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
The limited application that is set out in section four seems appropriate, however, it is not entirely reflected in the proposed amendments to NS 3.2. There is no consideration here of prospective collection of data specifically for research, eg for observational studies, or where third party consent is required.
4: Please comment on the flow chart (i.e. Section 4).: 
The flow chart again, seems based solely on situations where the data are to be collected for purposes other than research, or if collected for research are to be re-used for further, unrelated projects. It is also unclear what will happen where opt-out consent is approved, and it is known that certain participants have not received the project information.
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.: 
This is the major difficulty of this proposal, and there is no indication in the proposed revisions to chapter 2.3 what is intended. The problem lies in ensuring that participants have in fact received the information and are aware of the research. Otherwise, this process would effectively be a waiver of consent for some non-specific proportion of the proposed participant group. Our approach would be that an opt-out process be available only where there is a clear and specific method of contacting participants, and ensuring that they are aware of the research, as far as it lies in the power of the researchers to do so. This may involve handing a flyer to participants (eg where they are present at a meeting) or writing to them (where names and addresses are known). Where writing to potential participants (either email or mail), close monitoring would be required of bounce backs or returned mail. In the event that the information is not delivered, either that participant’s data should be removed from the data set, or waiver of consent should be put in place by the researchers to cover participants who prove non-contactable.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
2.3.9 This paragraph does not add anything to the NS requirements, but it appears to direct that ‘opt-out’ process should be considered as a low risk review option. We are not convinced, given the potential sensitivities indicated in 2.3.11, and the potential cross-over with waiver of consent, that this should be considered as a non-HREC review level. 2.3.10(b) states that “the proposed activity is of importance and is likely to serve the public benefit”. This falls somewhere between the public interest test required for waiver of consent, and the ‘research merit and integrity’ requirement for all research. If it is intended that opt-out research meet the public interest test, ie that the public interest in the proposed research substantially outweighs the public interest in the privacy of the participants, (as suggested in section 4.4 of the consultation document), then this should be stated. If it is simply a reference to the merit of the proposed research, that is covered by NS 1.1 (a-f) or 1.2, it should be deleted as it adds nothing to the existing requirements. 2.3.10(d) should include a specific requirement for participants to be provided with sufficient time from the provision of the information to decline participation. 2.3.10(e) states that “a mechanism for prospective participants to obtain further information and register their intention for non-participation is provided (where appropriate and practicable)”. The phrase “where appropriate and practicable” should be deleted. If participants are not provided with the opportunity to opt-out or to obtain further information if they wish to have it, this would constitute a waiver of the requirement for consent, not an opt-out process. 2.3.10(d) and (e) seem to have some redundancies. We recommend including the “mechanism for prospective participants to obtain further information” in 2.3.10(d) and delete 2.3.10(e). This would also rectify the issue identified in 2.3.10 (e) above. 2.3.10(h) states that “the data collected will be managed and maintained in accordance with relevant technical standards”. This is unclear. It seems to suggest that researchers will be required to follow appropriate data security /tissue storage procedures, which are standard requirements. This does not differ from research conducted with either explicit consent or with a waiver. If something else is meant, then it should be stated more clearly. 2.3.10(i) states that “there is a governance process in place that delineates specific responsibility for the project and for the appropriate management of the data”. What is meant by this? Again, it does not seem to add anything to the data storage required for any type of project. 2.3.11 states that “When considering the provision of information to prospective participants and the mechanism by which individuals can decline participation, the ethical review body should consider the sensitivity and the risks, the potential participant pool, the context in which the research and opt-out approach will occur…” This appears to be suggesting that the review body may essentially determine on a case-by-case basis how hard the researchers need to try to ensure that potential participants are informed about the research and are able to opt-out. This seems highly inappropriate and vulnerable to abuse. The potential consequences of this clause are ethically unacceptable particularly in the context of non-HREC review. In situations where there is not a practicable method of contacting potential participants, then a waiver of consent is the appropriate mechanism for managing the situation (see comments under 2.3.10(e) above).
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
As noted in general comments below, this draft relies on the idea that the data will be collected for purposes other than research, and the research use is primarily subject to consent or waiver. There are other ways in which opt-out consent might be used, for example in observational research, or in research where third party consent is required, eg conducting research with children in schools. In such situations it is particularly important that as far as possible, the information reaches the participant or their parent/guardian.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
It may be possible for researchers to post (send via regular mail) opt-out consent forms and assume that these have been received. Mail can be delayed or people move which would prevent someone from receiving the opt-out information. The lack of detail regarding how the researchers deliver or verify the delivery of the opt-out information is problematic. Another inappropriate case would be the use of opt out information provided in English only when there is an expectation of Non-English speakers to participate. This may occur in areas where there is a high prevalence of immigrants or with conditions which may differentially impact people of different ethnic origins. Adequate provision must be made for translations as set out in NS 5.2.16(b).
9. Can you provide examples where an opt-out approach may be useful?: 
In naturalistic observation research where incidental people may enter the observation frame, a form of opt out consent could be applied a priori.
General Comments
Comments: 

As it is currently set out, the proposal seems (particularly on the basis of the flow chart) primarily intended to allow the research use of data that are to be collected for purposes other than research, and for which research is effectively a secondary purpose. This in itself seems appropriate and is consistent with the low risk approach being taken to the proposal.

However, the proposed amendments to chapter 2.3 do not limit the uses of the opt-out process, and in particular do not specify the ways in which such an approach might be used for the prospective collection of data, primarily for a research purpose. Other types of research which might involve a potential ‘opt-out’ process might include observational research (videorecording participants at a public event), or research where third party consent might be required (eg children at school, or residents of a nursing home) and where information might be directly collected from a participant without formal consent being obtained, should the ‘opt-out’ information go astray.

It should also be noted that as the current proposal covers research other than health research, references to s95 and 95A guidelines will not cover all potential waiver situations.

It is clear that there is a potential for this process to merge with waiver of consent, given that the only people who will be contacting researchers are those who choose not to participate, or require further information. Other than by a bounced email or a returned letter, there is no way for a researcher to differentiate between:

  1. people who receive the information and agree to participate,
  2. those who received the information but did not read or comprehend it, and
  3. those who failed to receive the information and for whom there is no indication of this.

It seems then that there are three potential issues that are not addressed in this proposal:

  1. Whether the opt-out process can be appropriately used for prospective data collection for research (ie that would not be collected other than for the research project);
  2. How one can characterise a ‘reasonable attempt’ to contact potential participants in the project, and what should be the benchmark for this;
  3. What should be done in the case where it is clear (eg by a bounced email or returned letter) that the participant has not, in fact, received the information.

Page reviewed: 28 March, 2014