Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials

Kerry Woolfall; Lucy Frith; Angus Dawson; Carrol Gamble; Mark D Lyttle; the CONNECT advisory group; Bridget Young

doi:10.1136/archdischild-2015-309245

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Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials

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Re:A different view of studies with deferred consent
Kerry Woolfall
Published on: 14 April 2016
A different view of studies with deferred consent
Anthony M Kaiser
Published on: 18 March 2016

Published on: 14 April 2016
Re:A different view of studies with deferred consent
- Kerry Woolfall, Researcher
- Other Contributors:
  The CONNECT advisory group
The author makes an interesting point about the current legislation and automatic inclusion of data in trials where prior informed consent is not possible.
EU legislation focuses on when research without prior consent (RWPC) can occur and the need to obtain consent for continued participation, but does not cover the options for use of data collected prior to consent. The exception to this is where consent is not pr...
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The author makes an interesting point about the current legislation and automatic inclusion of data in trials where prior informed consent is not possible.
EU legislation focuses on when research without prior consent (RWPC) can occur and the need to obtain consent for continued participation, but does not cover the options for use of data collected prior to consent. The exception to this is where consent is not provided: ???he or she should be informed of their right to object to the use of data obtained from the clinical trial???. Therefore, this situation is open to interpretation.
We acknowledge the concerns of the letter author regarding not automatically including data. If data are not automatically included there is the potential for bias in the study results if the decision to provide consent for use the data is associated with patient outcome. This could potentially lead to erroneous conclusions with far reaching implications. However, the research community needs to consider the timeframes around stabilisation of the patient with respect to the potential need for continued delivery of the intervention, additional tests and timing of data to be collected after this point. It would be difficult to argue against the current legislation that consent should not be requested here.
CONNECT and studies conducted in neonatal intensive care indicate that children and parents not only want to be informed, but also want to make the decision about the inclusion of their information in research. One question to reflect on is who ???owns??? the data? If it???s the patient, then they (and their parents) surely have the right to be asked for it to be used.
We believe that the automatic inclusion of data with an ???opt out??? approach should be limited to circumstances where a face to face discussion with the family has not been possible before they leave hospital, or is not deemed appropriate at that point in time (e.g. when a child had died) and there has been no response to attempts to contact the family. This approach is currently used in a NIHR HTA funded EcLiPSE Study: Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus: http://www.nets.nihr.ac.uk/projects/hta/12127134
In developing the CONNECT guidance we had to work within UK and EU legislation ??? otherwise our guidance would have been of no practical use. Article 35 of the 2014 EU legislation stipulates that research in emergency situations should only pose ???a minimal risk to, and impose a minimal burden on the subject in comparison with the standard treatment of the subject???s condition???. Our interpretation is that if a trial intervention posed more than a minimal risk, then a REC should not approve the trial. The CONNECT study findings were in keeping with this, showing that parents supported doing RWPC in trials of interventions already used in clinical care, although they were concerned about doing RWPC in trials involving new interventions, or significant changes in clinical practice.
Conflict of Interest:
None declared
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Conflict of Interest:
None declared.
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Published on: 18 March 2016
A different view of studies with deferred consent
- Anthony M Kaiser, doctor
Thank you for outlining so clearly the current basis for "deferred consent" studies and suggesting good practice in dealing with the issues it raises. Unfortunately I believe that the current practice is the worst of possible worlds: not only do we submit vulnerable subjects to interventions without the expression of their/their parents' autonomy (ie consent), but also we risk losing any data obtained because we retrospect...
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Thank you for outlining so clearly the current basis for "deferred consent" studies and suggesting good practice in dealing with the issues it raises. Unfortunately I believe that the current practice is the worst of possible worlds: not only do we submit vulnerable subjects to interventions without the expression of their/their parents' autonomy (ie consent), but also we risk losing any data obtained because we retrospectively seek permission to use their data. In other words we would have put the subject at risk/burden with no gain. Current rules of governance for research, based ultimately on the declaration of Helsinki, are designed to protect the subject/society from harm, understanding that ends do not justify means. There is no possibility that the RECs and REC members of which I have experience would approve a study where undue harm could result. I believe that if an REC has approved such a study, this is an endorsement of its relative safety and utility, and should automatically permit inclusion of the data gathered. Retrospectively inform the subject/parents, but do not seek permission for inclusion. If they go as far as requesting withdrawal of the data, then that could be honored.
Conflict of Interest:
Member of Research Ethics Committee
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Conflict of Interest:
None declared.
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