This query refers to a clinical trial comparing two forms of treatment which has since been published in another journal.
I originally received this manuscript in 2009. One of the referees alerted me to the fact that the data looked strange. Furthermore, the test and controls groups were perfectly distributed, which is almost impossible. Along with the usual requests for modifications, I asked for the ethics approval letter to establish if the trial had been registered or approved somewhere and also expressed the concerns to the authors.
In the revised submission, I received a letter signed by one of the authors stating that the study was discussed at a departmental meeting and it was established that there was no need for ethical approval. According to my understanding of the matter, running a clinical trial in my country without ethics approval is a criminal offense. The authors also acknowledged that severe mistakes had been made to some of the measurements but did not admit to any wrongdoing.
I asked the authors for a file with some of the images from their study and the clinical data for each individual case. Authors who submit to our journal agree to make the original data available upon request during either peer review or later. The paper was withdrawn by the authors.
In the paper recently published in the other journal, the senior author as well as an assistant professor from the same institution listed as authors in the original submission that I handled no longer appear on the list of authors. Two additional authors are now listed. I originally did not pursue the matter when the paper was withdrawn from consideration in my journal as I understood that the authors had realised that there was something wrong. On publication in a different journal, however, I was alerted by the original referee that the paper that was withdrawn was now published.
I contacted the editor of the other journal who did not seem as concerned as we are with such possible misconduct. Essentially the complexity lies in the triangle between two journals and two institutions as well as in the possibility that two aspects may be wrong: the ethics and the data. The change in authorship for the same manuscript in the two submissions is also significant. Even though the paper was withdrawn from my journal, should I pursue the matter with the relevant officers of the two institutions involved?
The Forum agreed that the editor does have a duty to follow-up the case, even though the paper was withdrawn from his journal.
The editor should contact the ethics committee and/or the institution, and copy in the authors so that they are aware of what the editor is doing. The editor should send the ethics committee a copy of the paper and ask them if they approved the study. If they say they did not approve the study, then the editor should request that they investigate the matter. The editor should also raise the question of the change in authorship with the institution.
The editor should try and involve the other editor if possible.
Another suggestion was to write a letter to the other journal, as an author, raising the issues of the unusually smooth data and also comment on the apparent lack of ethics committee approval.
Acting on the advice from COPE, I contacted the editor of the journal that published the article. The answer was as follows: “I welcome any opportunity to collaborate to reduce scientific misconduct. With that said, the practical actions become more challenging. Perhaps if we can discuss this in person, we can define some practical steps to get started. We investigated the human subjects ethical review for the paper you identified, and the responses were acceptable. Although I have worked closely with ethical review boards in my country, you are certainly more knowledgeable than I about the details in your country. The practical details always make me nervous.”
Apparently, the journal found the ethics review acceptable and in the response it is apparent that no further follow-up is planned.
At this stage, contacting the ethics committees of the two institutions involved will be my next step. This is very delicate as this has already been done by the other journal (I am not sure if the ethics committee or the authors were contacted).
How should I proceed? Should the editor of the other journal be copied in on the correspondence? To whom should my letter be addressed—all authors from both versions of the papers or only those of the version that was originally submitted to my journal? And in terms of the ethics committee for the two institutions, should I cite in my letter that since the case falls outside the normal best practice guidelines, I have sought input from COPE?
Should I say that I contacted the other editor but failed to obtain a satisfactory response?
The Forum agreed that this case should ideally be investigated by the institutions. The advice was for the editor to contact the institutions, outline the facts, in a non-accusatory way, and request that they carry out an investigation. There is no need to copy in the other editor. If there is no response from the institutions or their responses are unsatisfactory, the Forum again suggested writing a letter to the other journal, as a reader, raising the issues of the unusually smooth data and also comment on the apparent lack of ethics committee approval.
As the other editor seems very reluctant to pursue the case, another suggestion was to go above the editor and contact the publisher of that journal.