• informed consent
• research governance

Rates of neurodevelopmental handicap are high among extremely low birthweight survivors, and the first 48 postnatal hours probably give the greatest opportunity for preventing damage. However, at this time, families are in turmoil and may have difficulty in coming to terms with a small baby in intensive care. We recently had to abandon an observational, non-invasive study because of practical difficulties arising from the new Research Governance Framework,¹ and we would like to share this experience, and its implications, with the research community.

We needed parental consent for the study, which had local research ethics committee approval. Babies had to be ⩽ 1500 g birth weight, > 25 weeks gestation, < 48 hours old, ventilated, with an arterial line, and no prior intervention for circulatory compromise. The last two requirements meant that, in reality, babies had to be recruited within the first 12 hours. A non-invasive measurement of peripheral oxygen consumption² was to be made regularly over 24 hours. We aimed to recruit 50 babies over two years.

When an eligible baby was admitted, the parent(s) were given further information before consent was sought a minimum of four hours later. Postnatal recruitment proved difficult. The need to give parents time to consider their decision meant that the opportunity for starting the study was often missed because of changes in the baby’s clinical condition.

With additional local research ethics committee permission, we tried to recruit women at high risk of delivering before term from 25 weeks gestation. The consent process was more complex in this group, as the explanation had to include information about standard neonatal care and procedures. Parents in this group were given 24 hours to come to a decision.

Figure 1 shows that, of 28 eligible babies, only five were recruited. Eight out of nine mothers approached antenatally gave consent, but only two of their babies were studied, as three did not meet the entry criteria and the other three were born elsewhere.

What went wrong? Since the Griffiths report,³ the emphasis has been on obtaining fully informed parental consent, and the research team has to ensure that the parents thoroughly understand the research and its implications. Research where parents signed consent forms, but later claimed that they did not understand the research, was heavily criticised.³ Consequently researchers are reluctant to approach parents who are in any way distressed, because of the difficulty in ensuring valid consent. If it is important for early neonatal research to continue, we urgently need agreement on a sensitive, humane, and realistic framework that is acceptable to both parents and clinical researchers alike.

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Figure 1

Recruitment to research project on neonatal unit (NNU) over 12 month period.