In summary, we have a case series, with no control group, of patients with different conditions treated for an undiagnosed underlying condition with an arbitrarily prescribed dosage of a drug which is not registered for treating any of the conditions nor the undiagnosed underlying condition. I rejected the paper for publication and let the author know that the ethics committee of the journal will review the paper.
There committee questioned where the institute was based. It was pointed out that in some countries, this type of procedure is standard practice. It was also pointed out that in the past, there is no response from the institution, and often no response. Also it was thought that perhaps journals had a role in publishing such a paper to illustrate what is going no in other countries.
The advice was to: (A) send the author a firm letter, (B) write to the institution, (C) write to the countries registration body.
The editor wrote to the author’s institution, asking them to investigate the author in the light of the lack of ethical considerations applied in the submitted study. No reply has yet been received. The journal’s own ethics committee discussed the problem of lack of ethical approval for studies conducted in institutions from countries where ethics committees may not exist. It was commented that failure to obtain ethics committee approval may not necessarily be an automatic bar to publishing a paper. Nevertheless, in studies such as this one, ethics committee approval would be expected. Furthermore, there are robust ethical guidelines available in the WMA protocols and the Declaration of Helsinki for authors to follow. It was suggested that an editorial on what to do with articles from authors who have no access to ethics committees might be appropriate. The editor is considering an editorial on the problem of lack of ethics committees in some institutions from developing countries