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Improvements to the informed consent process for neonatal research are considered
Informed consent is given when a competent person who has received and understood sufficient information voluntarily decides whether or not to receive treatment or take part in research. It is widely seen as an essential component of most medical research. In the case of neonates, parents must make the decision. However, there are a number of reasons to think that such consent is not likely to meet the criteria for being genuine informed consent.
Neonatal research often takes place in fraught circumstances. Parents may be suffering the emotional shock of unexpectedly having given birth to a seriously ill baby.
The need for consent may be urgent; in other words, there may only be a few hours in which the parents are able to decide (as in birth asphyxia trials).
The trial may be an “emergency trial”.1 These trials combine an urgent need for consent with the fact that the research is into interventions that are aimed at dealing with a life threatening condition—for example, extracorporeal membrane oxygenation (ECMO).2
The trial may involve a number of complexities. These may be difficult for lay people to understand, particularly when under stress.
In other words, the anguished parent of a severely ill baby has to process very complex information and make a decision on behalf of that child in a short period of time. It is hardly surprising that clinicians have long doubted that such decisions constitute informed consent. These doubts seem to be confirmed by recent research.3,4
One of these research projects, the Euricon trial,4 involved neonatologists, ethicists, sociologists, and legal experts from 11 European countries. Their discussions of possible improvements to the informed consent process form the basis of this editorial.
Not all neonatal trials …
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