Signed informed parental or legal guardian consent is required for babies participating in NEMO. Informed consent in neonatal research is complicated by the issue of proxy consent. McKechnie and Gill (2008) state that valid consent to neonatal research must be:
There are several possible circumstances complicating the validity of informed consent in neonatal research. These include shorter times available in which to consent, mothers having undergone traumatic births involving medication, impairing their capacity to think clearly, and fathers who may be emotionally overwhelmed (Allmark and Speeding 2007). Parents or guardians may not fully understand research terminology such as randomization in the short time to consent. Furthermore they may feel pressure to consent to research given that their new baby's life is at risk. Given that neonatal research often takes place in fraught circumstances, there are reasons to consider that such consent does not meet the criteria for true informed consent (Allmark et al., 2003).
The NEMO parental information sheet for a study involving neonates has been approved by the local ethics committee of P2 for a study on seizure monitoring in babies. We are aware that consent is a dynamic, continuous process. Therefore consent will be sought at the beginning and maintained during the trial as part of the ongoing dialogue between parents and investigators.
We are fully aware of the need to involve the parents in the study, while at the same time giving them as much support as possible. Their predicament is incomprehensible: the joy of birth followed soon after by the anguish and fear for their sick newborn baby. It is a very difficult and vulnerable time for parents to have to make a decision about research. Psychological and counselling support is offered to all parents in the NICU and we will ensure that all parents are aware of these services. We will always aim to approach parents together when obtaining consent for this research as our experience has been that it is easier for parents to understand and cope with the consent process when together. Most of the recruitment centres in our consortium have participated in the recently completed TOBY trial (randomised controlled trial of hypothermia for babies with HIE), and are used to obtaining consent from parents of very sick babies in a considerate and sympathetic way.