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

ID: 
22
This submission reflects the views of
Organisation Name: 
Central HREC Chair, The University of Melbourne
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 proposed definition says opt-out consent is a method of recruitment, but this is not accurate. It is a method of obtaining consent. It is important to get this right. Once it is accepted that this is an acceptable way to obtain consent (i.e. to take non-refusal as consent), then there are some obvious connections with how to recruit, but they are not one and the same. Note also that it is possible to have an opt-out recruitment strategy, but that is not the same as opt-out consent. An opt-out recruitment strategy involves sending a letter to potential participants (using contact details that are on the public record, or are available to researcher by some other means), saying that we will contact you by phone to ask you to be involved in this research, unless you tell us that you don’t want to be contacted. This is opt-out for contact, not opt-out for actual participation. It may be useful to include this in description of what opt-out consent means, for greater clarity. This method of recruitment is in use, and is believed by researchers to increase participation rate.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The rationale proposed for opt-out consent is problematic in two ways. Firstly, is too specific to clinical registries – opt-out consent is a viable option in a number of other, quite different contexts. Secondly, it focuses too much on the need to get sufficient numbers for scientific validity. There should also be explicit discussion of the consent/autonomy aspects, viz that opt-out consent does allow people to make an informed choice, and so is a way of respecting autonomy (in contrast to waiver of consent, which does not respect autonomy at all or at best just assumes that people would agree if they were asked). The features that make opt-out consent ethically viable are 1) send full information 2) people receive it and read it 3) are able to act on it to ‘opt out’ / withdraw.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
NHRMC has to decide whether they want opt-out to apply to research other than clinical registries, or epidemiological research using existing data. In particular, would opt-out consent be acceptable where there wasn’t a rationale in terms of numbers needed for scientific validity e.g. in qualitative research, where there is no statistically calculated sample size, and no need for statistical significance.
4: Please comment on the flow chart (i.e. Section 4).: 
The flowchart seems only to apply to clinical registries and not other kinds of research. Again, a decision is needed as to whether opt-out consent is acceptable in other contexts. If so, different or additional flowcharts will be needed.
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.: 
There should be specific direction about what counts as a good enough attempt to contact people. If there is an old data-base of names and addresses, researchers might know that 30% of addresses will be wrong. Would posting letters to these addresses count as a reasonable attempt? Some standards are needed. The researcher should take care to deliver information in a way that maximises the chance that information reaches the right person in the right time frame, and that there is an easy and simple way for them to respond to say no. Direction should be included on how information should be provided (registered mail, or mail, or email would seem acceptable, but not a notice in a newspaper or on a website), and how long researchers should wait for response before deciding there is no refusal (more than a day, a week at least seems reasonable) and what method of contacting researcher is available (e.g. return envelope to be included, to allow for people who don’t have access to email). Consider also adding some direction in relation to checking to see if addresses are still current, and that no one has died since last being contacted. Is it important to establish what evidence researchers have that people even know their data/tissue is in a registry, or that their names and contact details are recorded in relation to the issue being researched? What if they don’t know that they had genital surgery as a child, or had been black-listed by their bank? Would opt –out consent be acceptable in that situation?
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
As per the comments above these sections will need further detail as to what kinds of research can use opt-out consent and in what circumstances. It is not clear from the current text that this is restricted to clinical registeries but there is no comment on other research.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
• Where information (or tissue samples) is already held by researchers, along with contact details for the people to whom the data or tissue pertains – i.e. existing data/tissue • When data/tissue is going to be collected for a non-research purposes (e.g. clinical care, educational reporting etc), and researchers want to also use this data/tissue – i.e. new data/tissue • Observation of people in natural setting e.g. at work, in nursing home, in prison People to be given sufficient information and time to make a decision to be included or to opt-out.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
• Children and non-competent adults: researcher has interaction with participants when proxy (parent/guardian) is not present. The child or non-competent adult may not have been told or understand that interaction is solely for research purposes. This could occur very readily in schools or nursing homes, and could involve quite significant interventions – filling in questionnaires, being interviewed, being involved in activities, having tissue taken for testing of various sorts etc These situations need further consideration and opt-out may not be appropriate the more intrusive the research is.
9. Can you provide examples where an opt-out approach may be useful?: 
See comments in Questions 7 & 8 above.
General Comments
Comments: 
  1. It is appropriate for the National Statement to have a section on opt-out consent, as it is being used in practice, and is sometimes ethically justifiable. Guidance for researchers and HRECs would be very useful.
  2.  There is a need to cover opt-out consent when consent is to be given by proxy – either parents for children, or guardian/next of kin for non-competent adults. First establish whether this is acceptable at all, and then set out circumstances in which it is acceptable. It is very important to do this because much more can be done to people with opt-out proxy consent, than with opt-out consent for self. The person consenting may not be present with the person to be involved in research – think of school or nursing home settings.  It might be appropriate make tighter restrictions on proxy opt-out consent than on opt-out consent for self. It is not clear that simply restricting opt-out consent to low-risk projects only would achieve best outcome – that may be too blunt an approach. 
  3. It would be important to have guidance on whether to use waiver of consent or opt-out  consent – or are these being seen as equally ethically sound? One reasonable view is that opt-out consent is the better approach, and waiver should only be used when there is some problem with opt-out consent, such as relatively low likelihood of getting information to the people whose consent would be sought via the opt-out approach. Waiver of consent requires greater ethical justification, because no consent is sought at all, no-one gets to find out what is being done with information about them, and there is no choice. Opt-out consent does allow at least most people to find out, and also to exercise choice.   What would be the justification for doing waiver when opt-out is an alternative approach? Guidance on this would seem to be called for. Also, it is important to distinguish opt-out consent from standing consent (see NS chapter on children, 4.2.10 – 4.2.12), or, if there is no distinction, drop the idea of standing consent. Opt-out consent seems ethically preferable to standing consent, because parents get specific information about each research project, rather than giving blanket consent to research about which they have no specific information.
  4.  In relation to level of risk, it might be worth considering the type of information that researchers could receive from a registry or existing data set. Even though the information in the registry may be identified (or identifiable), it could be provided to researcher in such a form that the researchers have no way of re-identifying the data to know who the participants are. The registry may collate data on behalf of researchers, and provide it to researchers with individuals numbered, and no way of connecting that number to any identifying information. This approach would reduce the level of risk in relation to accidental breach of confidentiality, and may be, for example, a feature that would mark a distinction between requiring opt-out consent and allowing waiver of consent.

 

Page reviewed: 28 March, 2014