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

Personal Details
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Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
I am also an Intensivist who is involved in the local conduct of clinical trials from time to time. My interest in the design and ethics of these trials led me to join the local ethics committee, where I am of course now prevented from joining the discussion at length on specific critical care trials! This is overall an excellent document and is improved by the proposed changes. The definition of "opt-out" is similar to the common language definition. I would go further by saying that it is similar to the definition applied to delayed consent in ethics committees.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
There are several proposed safeguards against inappropriate use of opt-out consent (for example, that it should not be used for research in which there is significant risk). These are negative directions, but the positive direction is limited to that of avoiding data drop-out and so to reduce bias or increase efficiency, as measured by the Power yield of inferences for a given input of effort. It would be helpful to expand the positive list a little, such as to be able to include those who could generally be thought to assent as widely as other groups, but who are unable to do so. The dependent status of critically ill patients, for example, is no more a barrier to their ability to participate in a trial than the status of patients under long term follow up for chronic disease, but their ability to communicate is a barrier. In this case, delayed consent is often used. In its current form delayed consent is closest to opt-out in consideration of the ethics of random allocation and observation of results; many ethics committees, including ours, tend to discuss delayed consent in terms identical to opt-out; hence the scrutiny applied to studies which aim to use delayed consent is familiar to ethics committees. This process of scrutiny will benefit from formal recognition and very slight expansion under the current proposals which are generally measured and very good.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
Research questions which are essentially technical (such as the comparison of two intravenous fluid or feeding strategies or two strategies of resuscitation which are considered by experts to be of unknown and probably similar value) are vital to the improvement of healthcare delivery, by measures of efficacy, efficiency, cost and humanity. These studies may have wide acceptability but be limited by issues of consent "in the heat of the moment"; my impression from analogous discussions around organ and tissue donation is that acceptability of a study may be very high, once a protocol is properly put out to consultation in plain language and with appropriate explanation and moderation, yet its uptake may be much lower. One way in which the benefits of this approach to the public, and to trial participants, may be increased is to allow wider use of opt-out consent once public consultation has demonstrated this acceptability. This in turn may lead to the wider uptake of novel trial designs such as Bayesian adaptive designs, which have a higher chance of meeting public expectations of benefit by allocating more patients, over time, to the better-performing arm of the trial. In such a special case of broad public approval and a clear scientific imperative to follow less-stringent consent approaches such as "opt-out", I believe there is a strong case to widen the application of the opt-out approach to those studies which are considered more than low or negligible risk.
4: Please comment on the flow chart (i.e. Section 4).: 
This is very clear. As explained above, I would consider wider application of the opt-out principle but I'm sure this does not need to appear on the "ready reckoner" headline flow-chart.
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.: 
This must depend on the trial, unfortunately. It may be appropriate in a large cluster-randomised crossover trial of institutional approaches to, for example, selective digestive tract decontamination, simply to inform patients and relatives by posters, by a brief mention during a clerk-in process and with handed out written material, with specialists on hand to explain the approach further. If the reason for opt-out consent is that a time-critical intervention requires longitudinal follow-up, then specific opportunities for opt-out would be more important and would require some structure, with appropriate resources and time given to each interaction.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
These are moderate in scope and helpful in specificity.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
See above; after public consultation or using novel trial designs, or combining these two approaches, it may be appropriate to broaden the scope of opt-out consent.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
No: the safeguards are the same as those applied to other studies. They do not in themselves seem to allow inappropriate opt-out. Situations in which otherwise low-risk studies may prove to be more invasive than anticipated by means of the opt-out approach might include acquisition of complete information from a defined community, so allowing identification of the community or members. This example, however, is specifically excluded by the guidelines; common sense alone would demand re-triage of such a study as high risk and the chances of a mistriage are not increased by these guidelines
9. Can you provide examples where an opt-out approach may be useful?: 
See above

Page reviewed: 28 March, 2014