Data manipulation

A journal received an enquiry from a reader stating that they had found some discrepancies in the spectra published in the electronic supporting information for a published paper. They suggested that the discrepancies would be consistent with the spectra being manually ‘cleaned’. If this were true, the characterisation and purity of the compounds reported in the paper would be called into question.

The editor checked the spectra in close detail and verified that the discrepancies that the reader had identified were a reasonable cause for concern. The editor also checked the author’s related papers in the journal and identified a total of four papers that were affected by similar discrepancies in the spectra. When the editor contacted the lead author to discuss the concerns, they explained that ‘cleaning’ spectra to remove impurity peaks was not a practice that was carried out by their research group, and they did not believe that it had occurred in this instance. However, the researcher who had carried out the analysis had now left the group and the original data files where no longer available.

As a comparison with the original data files could not be made, the journal approached an independent expert to obtain a second opinion on the evidence available in the published spectra. The expert confirmed that there was clear evidence that the spectra had been altered and that this could be consistent with an attempt to overestimate the yields for the reported reactions.

Following this, the journal contacted the director of the institute to request their assistance in determining whether the spectra had in fact been altered. The director consulted with the lead author and the head of their facility. They confirmed that it was not possible to locate the original data due to a limitation of their archival system. They stated that their internal review had not found any ‘intentional altering of the spectra’. They stated that on that basis, the papers should not be suspected and should be allowed to stand.

This recommendation runs contrary to the evidence that we believe can be seen in the spectra, but in the absence of the original data files it is difficult to make a conclusive judgement.

Question(s) for the COPE Forum
• What action should the editor now take to resolve this matter? The journal is considering two options:
—accept the research institute’s recommendation that without evidence to prove deliberate manipulation of the data no further action should be taken.
—publish an expression of concern notice on each of the affected articles stating that discrepancies in the spectra were identified, the institute was asked to investigate, but that the original data were not available and they found no evidence of deliberate manipulation of the spectra.

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?

Journal A has accepted a meta-analysis for publication. As is standard practice for many articles accepted in this journal, a key expert (Professor X) in the relevant field was invited to submit a commentary on the paper. Professor X expressed concerns to the journal that “we believe that some of the papers included in the review could be either fabricated or at best are heavily plagiarised”. The papers included in the meta-analysis are all primary studies published in peer-reviewed journals.

Journal A requested some evidence for the concerns raised by Professor X.

Professor X has already tried to investigate the potential research misconduct of the primary studies. He sent a comparison of five studies, three of which were included in the meta-analysis accepted by journal A. Professor X claims strong evidence of plagiarism, and questions whether the trials took place at all. He also notes that he has previously written to the authors of the trials but says that few have responded. Those that did respond, he believes, have failed to provide reassuring responses.

Example response from authors sent to Professor X include the following: “The work has been actually undertaken after proper clearance. And details of the same are available with the competent authority.” “We don't want to be get disturbed as I discussed with our main author.” “Excuse us..Bye”.

Journal A has now halted publication of the meta-analysis.

The editors of journal A are unsure how to proceed, as the potential research misconduct lies with research not submitted to the journal, but rather primary studies included as part of a meta-analysis submitted based on the “available data”.

Question(s) for the COPE Forum
(1) How do we establish whether or not the primary studies are fabricated?
(2) Is it journal A’s responsibility to pursue this investigation or should it be the responsibility of the journals in which the primary studies are published?
(3) How should journal A proceed with managing the meta-analysis accepted for publication?

Author A submitted a trial comparing the safety and feasibility of two delivery techniques in patients. The trial, which was done at author A’s institution, was assessed by inhouse editors, who decided to send it out for peer review.

During the peer review process, some reviewers pointed out that “this work seems premature, experimental and hard to believe”, and also expressed suspicion about the result (ie, 100% procedure success rate). One of the peer reviewers, reviewer X, who works with author A at the same institute in Europe, and who was also acknowledged in the author’s submission, provided further comment. In his letter to editor, he stated that “I have reviewed some of their manuscripts more than 10 times, and I have refused to be associated with their research, because I had no access to the raw data on which there is an embargo made by the military authority in this country.” He continued that “it is fair to say that the data are unbelievable, without a negative or positive connotation. If the data exist and are correct, they will deserve a Nobel Prize.....as a matter of fact, a fake document has been circulated and the hoax has been disclosed in a very elegant way by a young colleague”.

After discussion among editors at our journal, we decided to reject the manuscript and ask for an investigation by the author’s institute. However, since the European institute already seems to be aware of the likely fraudulent nature of these results, and we cannot find contact details for anyone at the institution, we would welcome your advice on to whom we might best direct the investigation.

A director of an institute in France has expressed concern about a paper published in our journal. One of the authors (not the corresponding author) of the paper, person A, visited his laboratory in France for 5 months in 2009 to carry out some work. The director says that some methods used and results obtained in his laboratory have now been included in the paper without his knowledge or permission. Researchers from another institute in a different country are co-authors of the paper, and the corresponding author is someone from that institute. The director in France acknowledges that the experiments could have been repeated in conjunction with this other group, but says that it is not very ethical to work in this way.

I would be grateful for any advice on how to proceed in this matter. We have replied saying that we would contact COPE for advice.
In 2010, the editor-in-chief of another journal contacted the French group about a paper submitted by person A which included several members of the French laboratory as co-authors without their knowledge and permission. That editor-in-chief was concerned about apparent falsification of data by manipulation of a gel photo, which the French group were able to confirm. They contacted person A and the departmental head but have had no response.

A scientific paper was submitted in January 2011. After initial assessment by the journal’s editor-in chief, it was allocated to one of the co-editors. By chance, the co-editor had reviewed the manuscript for another journal only a few weeks before. The manuscript had been rejected by the previous journal for a number of methodological flaws.

The resubmitted manuscript contained significant changes to both methodology and results apparently correcting the flaws noted in the previous reviewers’ comments. Realistically, these changes could have only been possible if the study had been repeated but as only a few weeks had elapsed since the previous rejection, the editor suspected fabrication of results.

The editor contacted the editor-in-chief to highlight a possible case of misconduct. The manuscript was rejected primarily because it was not of a sufficient standard to merit publication and also because of concerns regarding the possible falsification of results.

In his letter to the author, the editor-in-chief asked for an explanation of the differences between the two manuscripts. The reply claimed that additional patients had been recruited. Of note, the demographic details (including age, height and weight) in the revised paper were identical to the previous submission, making this explanation unlikely.

In view of the unsatisfactory response from the lead author, a letter was sent to the dean of the faculty of medicine at the author’s institution but no reply has so far been received. Information regarding the academic department in this university has been difficult to obtain as their website is unhelpful so it is not clear if this letter was received by those in authority. Consequently, after several months and following discussion with the journal’s publisher, it was decided not to pursue this enquiry further.

Recently, another manuscript from the same department has been submitted. The co-author of the previous paper is listed among the five authors of this new submission. It is not clear, however, if this author was complicit in the previous case of alleged misconduct. The lead author of the previous paper is not included.

This paper has been reviewed and is again of a poor standard that does not warrant publication. There is, however, no reason to suspect misconduct with this current study.

The editor-in-chief has so far not responded to the authors regarding publication but has asked for the contact details of the head of the academic department from the lead author. An email reply included a contact name. A letter to the academic lead asking for clarification of the previous submission has been sent. A reply is awaited.

At present it is impossible to establish whether the previous misconduct is the result of a single rogue researcher or an institutional problem with research governance. The failure to receive an adequate explanation may simply be a problem with contacting somebody in authority who can investigate the conduct of research within this department. It is however, difficult to believe that a co-author of a paper where misconduct almost certainly occurred was not aware of such behaviour.

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?