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

Personal Details
First Name: 
Last Name: 
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
1 While I recognise that the terminology is 'opt out approach', this section is included in a chapter concerning consent. In my view, there is no possible way in which an opt out approach can be considered to constitute consent. At its basics, consent involves an active process involving a positive decision by a legally competent individual based on an adequate understanding of the facts. People conducting research using an opt out approach and members of an HREC approving such cannot be assured of any of these conditions. I believe it is misleading of the NHMRC to include any discussion of an opt out approach in a chapter concerning consent. 2 Focusing on the proposed definition, I believe that the word 'provided' is inappropriate. I think that the best than can probably be said about most cases in which an opt out approach may be utilised is that information will be 'made avaialable' to prospective participants.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
Broadly speaking I can understand the rationale. What I am not convinced about is that if more effort was used by the researchers or whoever explicit consent methods could not be used. It seems to me that choosing an opt out approach is often an excuse for poor quality consent procedures, and there is published evidence to support this. And if proper consent procedures were used and a substantial proportion of prospective participants declined to participate that would be good evidence that an opt out approach was not appropriate because it is choice not laziness that prevents people participating. And if something is so important that everyone must participate regardless of their personal opinions (for instance a national census or possibly a cancer registry or birth defects registry), legislation should be passed to make it an offence not to participate.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
4: Please comment on the flow chart (i.e. Section 4).: 
Seems reasonably clear but I disagree with 6d. See below. I believe this should be removed.
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.: 
I find it difficult to believe that there is any way in which it would be possible to ensure that all necessary people received the necessary information in this circumstance, or if they did that it would make any great sense to them possibly several years after the event that precipitated their inclusion in the data base.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
See my comments to Q1 above. In 2.3.10 I believe that an ethical review body should also be satisfied that there all feasible alternatives have been considered and have been excluded for valid and ethically justifiable reasons. Regarding 2.3.10.f, if personal follow up is involved, explicit consent should be sought at that stage.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
No comment.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
Probably but we'll have to wait and see.
9. Can you provide examples where an opt-out approach may be useful?: 
Not really because I believe the current mechanisms in the National Statement are adequate and otherwise legislation should be used.
General Comments

Nothing further.

Page reviewed: 28 March, 2014