Is venepuncture in neonatal research ethical?
Department of Child Health Royal Devon and
Exeter Hospital
Correspondence to: Dr J H Tripp, Department of Child Health, Postgraduate Medical School, University of Exeter, Church Lane, Heavitree, Exeter, EX2 5SQ.
Accepted 11 March 1997
AIM
To determine whether venepuncture accords with
the accepted (BPA) criteria of not causing more than minimal physical
or psychological distress during non-therapeutic research.
METHODSNinety 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.
RESULTSOnly 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.
CONCLUSIONSVenepuncture 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.
© 1997 by Archives of Disease in Childhood
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This article has been cited by other articles:
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Gammelgaard, A, Knudsen, L E, Bisgaard, H
(2006). Perceptions of parents on the participation of their infants in clinical research. Arch. Dis. Child.
91: 977-980
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