Eighteen patients with a variety of symptoms and 10 controls had various measurements taken after being given an oral glucose load. Participants also had routine blood sampling and were put on a defined diet for three days. The authors did not consider it necessary to obtain ethics committee approval, but all participating subjects signed a consent form recording their agreement to take part and to have the results published. The authors seem to be private practitioners. The journal does not want to publish the research as it’s scientifically meaningless. In a similar case the editor had referred to the national regulatory body, the body had acknowledged that the research study under investigation was useless but that it was not a competent body to make a pronouncement about that. The editors also think that ethics committee approval should have been gained. The authors disagree. What should the editors do now?
_ Was there a national body that the authors would be registered with? Where would such private practitioners go to get ethics committee approval for such a study? _ In private health care research the lines of accountability are often unclear and this may have been an inadvertent omission on the authors’ part. _ Some groups did fall between organisations set up to approve research and it is difficult for them to know who to approach for ethics approval. The main problem for small private researchers is the incoherence of the structures. _ This problem becomes even more pronounced when authors are from other countries where the research ethics committee system is less comprehensive. Occasionally editors receive papers from countries with no research ethics review system. _ Editors should only publish research that would meet the standards of a research ethics committee in a developed country. _ In some countries though there is nominally a system in place, in reality the mechanism is purely administrative not ethical. Editors needed to be aware of this and should not assume that the ethics committee approval process had been carried out to the same level as in developed countries. _ As these particular authors are responsible to a national regulatory body, the editor should report his concerns to that body after informing the authors of his intention to do so. _ If the researchers are working in a private hospital, such hospitals do have research governance frameworks.