This is a collaborative project between Sara Schroter, Gary Bryan, Elizabeth Loder (BMJ); Jason Roberts (International Society of Managing and Technical Editors), Tim Houle (Wake Forest University, North Carolina), and Don Penzien (University of Mississippi, Jackson, MS).
Authors Elizabeth Wager, Sabine Kleinert on behalf of COPE Council Version 1 March 2012 How to cite this Wager E, Kleinert S on behalf of COPE Council. Cooperation between research institutions and journals on research integrity cases: guidance from the Committee on Publication Ethics (COPE). Version 1, March 2012. https://doi.org/10.24318/cope2018.1.3
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In June 2014 we received a manuscript by four authors from a well known research institution. They described a randomized trial comparing a variation in a procedure with standard care. In total, 200 patients were randomized, 100 to each arm. As measured by an interview, patients undergoing the new procedure were statistically significantly more content than those in the control arm. This manuscript was submitted 116 days after the same group of authors had sent us a first manuscript on the same topic.
The first manuscript, however, described an observational study: 50 patients had chosen the new procedure, 50 underwent conventional treatment. The patients rated the new procedure higher (statistically significantly). In their discussion, the authors mentioned as a limitation the non-randomized status of their study and called for a randomized comparison. At the time we rejected the manuscript because we were not convinced by the non-randomized design of the study. The senior author appealed our decision saying that it was very difficult and almost unethical to carry out a randomized trial. We did not change the decision but I granted the author that we would evaluate and possibly review a manuscript on a randomized study.
In the cover letter of the second manuscript, dated June 2014, the authors referred to this discussion and stated that 100 patients had been randomized to each group. [As an aside, in an online source detailing procedures carried out in the department of the authors, the procedure in question is said to have been performed more than 1200 times a year. As a consequence, it is conceivable that the authors have randomized 100 patients to each study arm during a period of 3–4 months. In his appeal to the rejection of the first manuscript, the senior author mentioned that the ethics committee had already expressed approval. And yet, common experience with randomized trials indicates that the present study would be an extremely fast trial regarding screening, consent, inclusion, examination (4 days after the procedure), and analysis.]
Here is the problem: the results are identical in manuscripts 1 and 2. In numerical form the results are only presented in tables (not in the main text and not in the abstract). In all three tables, the values are identical in both manuscripts. All three tables were submitted as one file, leaving open the possibility that the author mixed up files. The figure (a horizontal, stacked bar chart) is slightly different but the numbers indicating the results, however, are identical. This figure was submitted as a different file.
The main text of the second manuscript is identical to the first one except for minor updates in relation to the numbers of subjects and study design. All four photographs illustrating the procedure in both manuscripts are identical. The reference list is identical.
I can think of only two ways to make sense of this submission: sloppiness or fraud. Under the sloppiness assumption, the authors would have submitted a text referring to their randomised control trial and tables, referring to an earlier observational study. This is conceivable mostly because it is hard to imagine that authors believe they can get away with submitting the same data in two manuscript describing two completely different trials and separated by only 4 months. On the other hand, the tables and figures differ in layout and several details from those submitted with manuscript 1. If sloppiness is not the reason, it must be fraud, and we can only reject the paper.
I feel we should be frank with the authors about our decision to reject the paper. Confronted with this decision, however, the authors have no incentive to cooperate with us and to send us, for example, original data. Rather, they may blame the mess to an unfortunate confusion.
Question(s) for the COPE Forum (1) We have decided to reject the paper but how does the Forum think we should now proceed?
The general feeling from the Forum was that there is enough reason for suspicion to require some sort of explanation from the authors. The editor should ask the authors for an explanation and, unless the explanation by the authors is convincing (which is difficult to imagine), then the editor should forward the matter to the institution of the authors.
Another suggestion was for the editor to ask the authors for a copy of the original study protocol and documentation of ethics approval. This would provide evidence that the trial did occur. If there is no study protocol, this would raise concerns.
The editor told the Forum that the journal is planning on rejecting the paper. However, even if the paper is rejected, the Forum advised that the editor can still contact the authors and tell them that he has identified specific issues with the paper and would like an explanation.
In summary, the Forum agreed that there seems to be some issues of concern with the paper. The editor should ask the authors for an explanation of this strange sequence of events, and if he is not convinced by their response, he has every reason to involve the institution.
A manuscript was submitted to our journal describing a study of a new drug. The manuscript had only one author who gave their affiliation as a company that we can find no record of online. It describes a study in which they appear to have developed a new drug, carried out a toxicology study in mice and then, because no adverse effects were seen, tested it on one patient and five healthy volunteers. There appear to have be no stages in between. There is no statement of informed consent in the manuscript. There is a statement that says the study was reviewed by the institution’s human subjects committee but we cannot find a record of the institution.
We had ethical concerns about the study so we asked the authors for more information, specifically: the details of the ethics committee that approved the study; whether they had informed consent from the patient and healthy volunteers; whether the trial had been registered before it commenced; how the patient and controls were recruited; what information the patient and controls were given before they agreed to participate; where the study took place; what safety/monitoring was in place in case of any adverse effects; what approval was obtained (eg, from the country’s drug regulatory body) before this drug was injected into a human for the first time; and what other research had already been carried out on this new drug? The author responded to our email asking to withdraw the manuscript but did not answer any of our questions. We responded that we had serious ethical concerns and therefore would not be withdrawing the manuscript at this time. We informed the author that we would be investigating the potential ethical issues and asked again for answers to our questions. We have heard nothing from the author since.
The author is based in a country that does not appear to have a national medical board and is not affiliated to an academic institution or hospital. The affiliation given is the company that we can find no record of. The author’s email address is not an institutional or company email address. We have contacted the professional society for the medical specialty of the author but they have informed us that the author is not a member and therefore they cannot investigate. We have also searched for the author on the registry of the regional medical board for the region in which the author is based, and they are not registered with them either. We do not want to reject the manuscript until an appropriate body has agreed to investigate but we are struggling as to how else to report this.
Questions for the COPE Forum (1) Does the Forum agree that we should continue to try and find someone to investigate this before we reject? (2) Does the Forum have any suggestions on how we can report this?
The Forum agreed that the editor had made a tremendous effort in trying to resolve this case. The Forum reiterated that in instances where a paper is rejected or withdrawn, there is still a responsibility to pursue any suspicions of misconduct. In this case, where the author wishes to withdraw the paper, it was agreed that the editor had probably done as much as he could. In some countries, this type of behaviour might be considered criminal, and a last resort might be to inform the legal authorities in that country.
The Forum advised that there is always the possibility that the paper is a hoax, but the editor has to assume, until otherwise proven, that the author has submitted the paper in good faith and should investigate this as far as possible. This is a particularly difficult case as it is a single author paper. If there had been more than one author on the paper, the journal could have applied the revised criteria of the International Committee of Medical Journal Editors (ICMJE). The fourth criterion states that all authors are accountable for all aspects of the work and are responsible for ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. However, this is not applicable in this case as there is only one author.
The only other suggestion was for the editor to write an editorial on this topic, emphasizing that this type of behaviour is unacceptable.
After the case was discussed at the forum, the journal made one further attempt to report the unethical research. This was successful and the case is now being investigated by the relevant governmental department in the country where the research was carried out. The editor also discovered that while he had been trying to resolve this case, the article had been published in another journal. He informed the editor of that journal of the duplicate submission and his concerns.
Follow up (June 2014):
After the relevant governmental department agreed to investigate, the manuscript was rejected by the journal. The journal did not receive a response from the editor of the other journal in which the article had been published.
During the 2nd World Conference on Research Integrity in Singapore in 2010, COPE helped develop two position statements setting out international standards for responsible research publication for editors and authors. They have been published as part of the conference proceedings under a Creative Commons licence* (details of the proceedings are available from the publisher, here).