A survey of doctors’ opinions, with no IRB approval or written consent
A doctor who trained in country A took the licensing examinations in country B because he wished to work in country B.
After the examinations, he carried out a survey (with a very poor response rate) of other doctors who had taken the same national licensing examination. The survey asked four major questions: How representative was the examination relative to the scope of your reading? How fair do you think this method of evaluation is to foreign medical graduates? What would be your most ideal method for evaluation of foreign medical graduates? Why did you immigrate?'
There was no IRB approval for this study and no mention of written informed consent. When asked to clarify ethical issues, the author stated: “No protocol was prewritten, as the question of what and who would constitute an IRB for such a survey on issues relating to foreign medical graduates in the transition was a difficult one to answer. Thus no ethical review was done. However, all participants were adults, of sound mind, and implied consent to have their opinions published.”
The paper has been rejected, but do the editors need to take further action? The risk of harm to the survey participants (all doctors) from this study seems low. Nevertheless, the survey might conceivably have included questions of a personal nature that could have caused distress (eg, reasons for immigration). The licensing board was not informed about the survey. If we report this doctor to the licensing board, it may well affect the author's chances of employment in country B.
As the subjects were not patients, some argued that it is not necessary to have ethics approval although others believed that ethics approval should always be sought for any study on human subjects. As the study involved a survey, all agreed that written consent was not required as the subjects could not be identified. However, the general view was that the author should have at least contacted the licensing board to ask permission to carry out the survey. The advice from the Forum was to write a strong letter to the author explaining the ethics involved in carrying out any research and suggesting that he should have contacted the licensing board before carrying out the survey.
As recommended by COPE, the editor wrote a stern letter to the author. In reply, the author thanked the editor and also noted that he himself was confused as to which institution should have been approached ahead of the study. The editor considers the case now closed.