Is venepuncture in neonatal research ethical?
OBJECTIVE
To determine whether venepuncture accords with the accepted (BPA) criteria of not causing more than minimal physical or psychological distress during non-therapeutic research.


METHODS
Ninety two venepunctures were carried out in 69 neonates between days 6 and 10 of life, and in some cases, on day 28. Parents were fully informed of the need for the procedure and allowed to attend while it was performed. Ninety parents and 87 doctors completed questionnaires to assess the levels of perceived parental and child distress and anxiety before and after the procedure.


RESULTS
Only three parents were very upset, and 47% reported the test as being better than they expected, compared with 10% who thought it worse than expected. Seven babies were recorded as being very upset. Doctors tended to underestimate the degree of anxiety before the procedure and the level of distress afterwards.


CONCLUSIONS
Venepuncture in neonates seems to be acceptable to most parents and is associated with a favourable risk: benefit ratio using semiquantitative assessment of risk and benefit.
Shah
V S
VS
Department of Child Health, Royal Devon and Exeter Hospital.
al-Khannan
M
M
Quinn
M W
MW
Tripp
J H
JH
D001007:Anxiety / Q000209:etiology; D001800:Blood Specimen Collection / Q000009:adverse effects / Q000523:psychology / Q000592:standards*; D004992:Ethics, Medical; D006801:Humans; D007231:Infant, Newborn; D033281:Nontherapeutic Human Experimentation; D010146:Pain / Q000209:etiology; D010290:Parents; D012106:Research; D018570:Risk Assessment