Cases Blog
A milk allergy n of 1 trial and the ethics of publication
Cases Journal recently published an article by Bruce Arroll, Harry Pert and Gordon Guyatt describing a trial carried out on two 6-month-old children to see the effects of replacing cow's milk with soya milk in their diet. The parents, worried that their babies' symptoms of diarrhoea, rash, irritability and wheezing could be caused by milk allergy, agreed to take part in the trial, which was randomised and blinded by their neighbours passing cow's or soya milk in identical bottles over the back fence according to the allocation schedule. The parents then kept diaries recording the children's symptoms for their GP, Dr Pert, to assess at the end of the trial.
Richard Smith, the journal's Editor-in-Chief, has written an editorial considering the ethical issues involved in publishing such a case. The authors did not get approval from an ethics committee for carrying out the trial. The families were not asked to give their consent for publication of this report when the trial took place (20 years ago) and the authors are no longer able to contact them to ask for consent now. Read the editorial to find out why we have published the article in spite of these ethical issues.
Posted by Elizabeth.Slade at 10:00 Comments (0)
