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The EarlyBird Diabetes Study started recruitment of 300 children in January 2000, and at the time of writing has entered phase II of its four planned phases. It is halfway through seeing the children for their seventh visit and retains 92% of the original cohort. The study takes venous blood samples annually, and has done since baseline when the mean age was 4.9 years. A selection of publications dependent on these blood samples is listed below.1–4
UK colleagues have sometimes queried the ethical justification for taking blood from healthy children so young, suggesting that their own ethics committees would be unlikely to give approval. Ethics committees are there to protect the vulnerable, but their deliberations are a judgement, and it is important that this be guided by sound evidence as well as good sense. The aim of this letter is to reassure our own and other ethics committees that venepuncture causes little, if any, distress to young children, that it is safe, and that the information obtained can be substantial and useful.
The parent’s written consent at the start, and the child’s assent on each occasion, are obtained. An anaesthetic cream (Emla) is applied at least one hour before the blood test, which makes the process virtually painless. The child’s attention is averted by a slide viewer, and the paediatric nurse is expert. Very few children ever refuse, the majority are blasé, and some even choose to watch. To date, we have attempted 1057 venepunctures. Only 29 attempts—fewer than 3%—failed, mainly for technical reasons. There have been no complications.
With a three year experience of taking blood daily from young children, we have experienced no reaction from the study participants that might deter an ethics committee from approving venepuncture. The insertion of a needle into a properly anaesthetised arm is a minimal and safe intervention.