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Research ethics and children
Medical research involving children is essential for advancing child health and well-being.1
Research involving children and their families still attracts controversy. In a recent article published in this journal, there has been concern voiced at the layers of bureaucracy that attended the ethical review of a seemingly straightforward but important piece of research on the follow-up of children with cardiac disease.2 To some extent, the frustrations encountered by the researchers should now have been lessened by the implementation of the findings of the Warner report3 and the establishment of a National Research Ethics Service.
Nevertheless, the ethics of medical research involving children remains a matter of balancing protection against access.4 Some have suggested that a recent domination of protection has contributed to a situation in which children are ‘therapeutic orphans,’5 this term reflecting the lack of significant evidence for many aspects of current paediatric therapeutics. For example, in emergency childhood situations, the paucity of evidence for treatment regimes, due to the lack of randomised control trials in emergency medicine and paediatric intensive care compared with other areas of medicine, means that the very sickest children are subjected to evolved, anecdotal, medical practice. Similar non-evidence-based practice in adult medicine allowed lignocaine prophylaxis postmyocardial infarction and routine episiotomies until recent well-designed randomised controlled trials exposed their dangers!
However, the recent welcome address of this imbalance with strategies such as increased funding for paediatric research, legislation to encourage—and occasionally enforce—pharmaceutical companies to test drugs in children, and the setting up of UK MCRN have led some to question whether the pendulum may have swung too far away from protection of the weak and vulnerable.4 This is especially troubling as increasing globalisation affords greater research access to less empowered populations.6
A history of research ethics
Thomas Percival, a physician from Warrington composed …