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

ID: 
14
Personal Details
First Name: 
Merle
Last Name: 
Spriggs
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
It is not a method of recruitment. Opt-out is a form of evidence of consent where silence or non-objection is taken as consent. It is suitable for research that is no more than low risk.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
See comment on section 2.3.9 in question 8 below - i.e. my comment (ii)
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
An opt-out approach is only suitable for research that is negligible or low risk.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
(i) Where there is disagreement about what constitutes low risk research. (ii) Re. 2.3.9 - While it is acceptable for other review bodies (other than a fully constituted HREC) to make decisions about low risk research, it can be problematic when they are making determinations about the level of risk and subsequently approving the use of opt-out consent. For instance, those making the decisions may not include non-scientific members or lay people - it is possible that the review body or sub-committee is made up entirely of researchers. To illustrate why this may be problematic - those doing research involving children (research on sensitive topics) can become desensitized and not recognise the level of risk or the potential for harm. (iii) Where opt-out consent depends on written information but potential participants are from non English speaking backgrounds - the potential participants may not be able to understand or read the information. (iv) Written information where opt-out consent applies needs a clear statement/warning up front to the effect that "non-action on this matter equals consent from you!" - otherwise, if not interested or not wanting to take part, potential participants may not read or stop reading before that information is imparted. It is not acceptable for this information to come after a description of the study, benefits etc. (v) A combined approach that includes opt-out consent e.g. a multistage consent process (with different types of consent) may be good practice (gives people more options) but an accumulative approach is problematic - i.e. where other stages of opt-out (presumed) consent depend on presumed (opt-out) consent. An example is that you could end up in a register via opt-out consent and that may be quite acceptable but it seems problematic if after that a researcher who wants to recruit via the register applies for and is able to use opt-out consent or a waiver of consent. Is it possible to restrict the use of opt-out consent so that it can be used only once? (vi) Research with children that depends on non-objection from parents can be problematic. It can result in children being involved in research without parents realising. Even if the child's co-operation is required, children are used to doing what they are told to do by adults in authority.
General Comments
Comments: 

It is good that the issue of opt-out consent, which is already occurring, is being included in the National Statement.  This will provide consistent guidance to researchers and HRECs.  

Page reviewed: 28 March, 2014