A private practitioner submitted a paper in which he had treated a series of patients without ethics committee approval. Many people would regard the treatment used as scientifically dubious. Furthermore, some of the patients had been treated with increasing doses of a new treatment that randomised controlled trials have shown to work. In effect, therefore, the study was a dosage study of the new treatment. The practitioner admitted that he did not have ethics committee approval, and our judgement is that the study is effectively scientifically meaningless. It would be impossible to conclude anything with confidence. The men in the trial no doubt gave consent for the treatment, although there must be doubts about how informed their consent was. It’s not clear, however, whether they knew that they were part of a study. One of the complexities of this case is that if this practitioner had simply gone ahead and treated these patients then there would probably be no question of misconduct. But because he has chosen to write up the series as a scientific paper, the question of misconduct arises. We have referred the case to the GMC. Have we done the right thing?
_ The GMC had responded, saying that it had no role in this case and did no intend taking any action for serious professional misconduct. _ Shouldn’t the Preliminary Proceedings Committee investigate this in any case? _ Was this a study or simply normal practice during a surgical procedure? _ It had been written up, so it was evident that the author was trying to get it on the scientific record. _ Does a change in normal practice have to be reported in a medical journal before a change in procedure can occur? _ GMC should be contacted again for clarification.
The GMC responded by saying they would investigate if research were suspected of causing harm, if consent had not been obtained, or serious fraud or deception had been alleged. The standard required by journals as to what they published was not, however, a matter for them.