Parents often forget they consented to their babies taking part in trials

Parents can forget that they have consented to allowing their newborn babies to take part in clinical research, suggests a study in the Fetal and Neonatal Edition of Archives of Disease in Childhood.

The findings are based on the responses of 154 parents 18 months after they gave their consent to their babies participating in clinical trials. The parents had all been given written information at the time.

Almost two thirds (99) of the parents responded to the survey. One in eight (12%) of the parents could not remember being asked to consent to their child taking part in clinical research. A further 6% were unsure.

Eight out of 10 parents were happy about their decision. None said they felt pressurised to give consent. But entering their baby into a trial made one in four feel more anxious.

It is widely recognised that while obtaining consent safeguards a child's interests, it is beset by difficulties.

Having a sick newborn baby is very stressful for parents, and being asked for consent can be seen as adding to that. And it has been questioned whether parents are really able to make sound judgments in these circumstances.

Alternatives are being considered. But when asked if they would be happy to forgo consent if the trial had been passed by the institution's ethics committee made up of doctors and members of the public, more than 80% said they would not.

Despite best efforts, it is clear that an appreciable number of parents will not remember having given their permission, say the authors. "This could lead to considerable distress or mistrust. This problem should be addressed by researchers," they say.

Contact: Dr Ben Stenson, Neonatal Unit, Simpson Centre for Reproductive Health, Royal Infirmary Edinburgh, Scotland
Tel: +44 (0) 131 242 2574
Email: [email protected]

Click here to view the paper in full: http://press.psprings.co.uk/fnn/july/321_fn21931.pdf