© 2003 Archives of Disease in Childhood Fetal and Neonatal Edition
LEADING ARTICLE
Informed consent
Obtaining consent for neonatal research
1 Faculty of Medicine, University of Sheffield, Sheffield, UK
2 Northern and Yorkshire Clinical Trials and Research Unit, University of Leeds, Leeds, UK
3 Peter Congdon Neonatal Unit, General Infirmary at Leeds, UK
4 Department of Philosophy, University of Leeds
Correspondence to:
Correspondence to:
Dr Allmark, Samuel Fox House, Northern General Hospital, Sheffield S5 7AU, UK;
p.j.allmark@shef.ac.uk
Improvements to the informed consent process for neonatal research are considered
Keywords: informed consent; research; ethics
| The first 150 words of the full text of this article appear below. |
Informed consent is given when a competent person who has received and understood sufficient information voluntarily decides whether or not to receive treatment or take part in research. It is widely seen as an essential component of most medical research. In the case of neonates, parents must make the decision. However, there are a number of reasons to think that such consent is not likely to meet the criteria for being genuine informed consent.
- Neonatal research often takes place in fraught circumstances. Parents may be suffering the emotional shock of unexpectedly having given birth to a seriously ill baby.
- The need for consent may be urgent; in other words, there may only be a few hours in which the parents are able to decide (as in birth asphyxia trials).
- The trial may be an "emergency trial".1 These trials combine an urgent need for consent with the fact that
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