NHMRC Public Consultations

Skip Navigation and go to Content
Visit NHMRC website

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

ID: 
7
Personal Details
First Name: 
Philip
Last Name: 
Lee
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
The statement doesn't mention the quality and comprehensibility of the information. Suggest: A method of recruiting particpants into research where information provided about the research, their involvment and related activity, is at a level of comprehension that could reasonably be understood in which their participation is presumed unless they take action to decline [participation].
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
Generally clear but could be further simplified. Comment 3.1, line, add 'consent' prior to 'strategy' to read '...as a consent strategy for recruitment...' 3.2 line 2, add 'are experienced' prior to '... in other types ...' 3.3 line 1, Rephrase to 'Typically, publsihed data suggests that ...'
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
Are we talking about consent or approach here? It can be confusing; i.e. are we refering to 'opt-out consent' as an approach or 'opt-out approach' as an approach?
4: Please comment on the flow chart (i.e. Section 4).: 
Again, it is unclear whether we are discussing 'opt-out approach' or 'opt-out consent' process here?
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.: 
6d is fine; however, 6b is less clear; can Waiver be granted by other levels of Review Body for low and negligible risk; if so, the box doesn't allute to this.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
The wordings are rather convoluted and could be simplified. Suggests: First paragraph, line 1; 'Depending on the circumstances of an individual project, an opt-out approach to consent may be justifiable.' Second paragraph; 'In some instances, it maybe justifiable for a single research proposal to use different approaches to informed consent. For example, the project may have discrete elements that require explicit consent; and other elements where an opt-out consent or a waiver of consent maybe warranted'.'

Page reviewed: 28 March, 2014