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

ID: 
24
This submission reflects the views of
Organisation Name: 
University of Wollongong & ISLHD HREC
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’:: 
The definition of opt-out is clear.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
An opt-out approach moves the burden of recruitment away from the researcher, who currently has to demonstrate the value of their research to the potential participant, to the individual who is enrolled by default and now must actively withdraw from participation. Although the substantially higher opt-out response rate compared to explicit consent response rate is often cited in support of the opt-out approach, this more likely represents a disengagement from the research recruitment process than a truer reflection of participation rates when consent burden is reduced. Although there are issues regarding the integrity of research outcomes and the potential for selection bias with poorer response rates, this is not new and approaches are well established for assessing and addressing the impacts of these factors on scientific inference, such as the use of data linkage.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
The principle of limited application is appropriate. It needs to be carefully protected in the wording of the National Statement if the convenience of opt-out consent for researchers is not to drive a shift towards this being seen as generally acceptable for low risk research. This would be a failure to respect rights of individuals to control the use of their data.
4: Please comment on the flow chart (i.e. Section 4).: 
The flow chart differentiates Opt-out and Explicit consent according to low risk vs more than low risk. This distinction is simplistic and diminishes the importance of obtaining consent (and thus consideration of respect for autonomy) in low risk research. The principle of significant public benefit being key to the acceptability of this approach is not incorporated in the chart. A significant concern with the opt-out approach is its potential for misuse in establishing health information systems that are ostensibly for clinical applications but have an underlying, upfront research purpose. The flow diagram does makes a clear distinction between establishing data collections for research and non-research intents, but there is insufficient advice as to what constitutes “a non-research purpose”.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
Section 2.3.10 (b) requires stronger wording, similar to that used in the Background paper in 4.4 on ‘Limiting the use of the opt-out approach’, which states that “a key criterion for HRECs to consider is whether the public interest in the proposed activity substantially outweighs the public interest in maintaining the level of privacy protection afforded by the National Privacy Protection”. The language in the Draft chapter, i.e “is likely to serve the public benefit” is soft and vague. The rationale for an opt-out approach (Section 3) clearly points to advantages for improving recruitment as well as decreasing the burdens associated with recruitment for researchers. There already appears to be an increasing trend to ‘recognise’ the value of clinical data for research purposes (5.a of Flow Chart) and an opt-out approach facilitates and optimises the use of data in this setting. It is therefore important for the wording to be clear and strong. This would better serve HRECs in determining the limitations of an opt-out approach and would place greater responsibility on researchers to give more serious consideration to research design and merit when weighing up the suitability of an opt-out method for recruitment. Whilst the background paper acknowledges the disadvantages for the participant (2.3,2.4;p5) the criterion used to in 2.3.10 d) which aims to protect patient autonomy only refers to ‘reasonable attempts…for all participants ’. There is an inherent tension in this as the word ‘reasonable’ could be interpreted widely, while on the other hand ‘for all participants’ could require very specific attempts to satisfy this aspect of the criterion. There needs to be an explicit requirement that the information provided be appropriate to the participants involved, taking into account key aspects of communication such as literacy levels and English speaking skills. Clause 2.3.10 (d) should include a requirement that the source of the details used to contact a person for opt-out consent be disclosed in the consent information, e.g. you have been contacted because you were a patient of..., and a justification as to why the individual has been automatically enrolled into the research. The requirement in 2.3.11 for the ethical review body to 'consider' specific aspects of information provision and mechanisms for withdrawal provides no guidance on what minimum acceptable standards are. To address this clause 2.3.10 (d) should require that the opt-out procedures facilitate easy withdrawal for people and have no financial burden (e.g. prepaid mailing envelope, toll-free number, secure email or internet form, etc) and that participants receive clear advice on what opt-out procedures can be used.
9. Can you provide examples where an opt-out approach may be useful?: 
Research on established data collections for quality assurance purposes, which would fit with the intent of the change and flow diagram.
General Comments
Comments: 

It would have been helpful to include some categories or types of research, particularly given the increasing use of opt-out recruitment in primary care and the growing number of requests to utilise this form of recruitment from the social sciences.  This would have made interpretation of the background paper and the draft more meaningful. 

Page reviewed: 28 March, 2014