An unethical ethics committee?

A paper was submitted, detailing a double blind placebo controlled food challenge to a group of children. The reviewer considered the study unethical because he was concerned consent could not have been properly informed. He believed there was a very small risk of anaphylaxis—even death—and had this been explained to the parents, they would not have consented. The editor considered that the reviewer could well be right. The reviewer requested an independent investigation and stated that he would inform the General Medical Council about the study if the editor did not. The independent investigator requested the ethics committee correspondence and patient information material. It transpired that the ethics committee, which was responsible for all three trusts, on submission, had recognised the potential danger and notified the lead author that it would obtain independent advice. It asked for clarification on nine points. Six weeks later the lead author wrote to his colleagues that after discussion with the chairman of the ethics committee the latter had agreed the proposal was part of normal clinical practice rather than a clinical trial so did not require ethics committee approval. The study went ahead. Subsequent correspondence made it clear that the study had not been given an investigative reference number. The information leaflet referred to the possibility of an allergic reaction and that a specialist registrar would be on hand at all times to deal with it. No reference was made to anaphylaxis or death. Since the study, the responsible bodies for ethics committees, district health authorities, have been abolished. The editor telephoned the chief executive of the regional NHS office who thought he might be responsible for the committees but wasn’t sure. The editor wrote to the authors saying that the procedure was not normal clinical practice and that patients had been inadequately informed. The editor wrote to the ethics committee chairman, expressing concern, and is awaiting a reply. The editor also wrote to two of the trust chief executives and the research and development director of the third, from whom he is awaiting responses. Curiously, the research and development director is a former editor of the journal in question.