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Legislation and drug trials
  1. Department of Paediatrics
  2. University of Sheffield
  3. Sheffield Children’s Hospital
  4. Sheffield S10 2TH

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    Editor,—In their recent leader, Walsh and Drumm point out important difficulties facing paediatricians wishing to conduct intervention trials where the aim is to prevent disease in children (or anyone incapable of giving fully informed consent) in Ireland.1 It is worth pointing out that the Irish legislation that prevents such studies thereby prevents all vaccine studies in children from being conducted in that country. Vaccines against Haemophilus influenzae type b and more recently acellular vaccines against pertussis have been licensed and introduced in Ireland on the basis of immunogenicity and efficacy studies done elsewhere. While it is not necessary for each vaccine to be studied in every country, there is a clear need for all countries to be able to contribute clinical studies particularly as the number of new antigens and combinations grows. It is to be hoped that the current stranglehold on research into child health in Ireland is loosened in the near future.


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