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.
As managing editor, I view all manuscripts before they are assigned to an editor. Within a 4 week period, I have detected five manuscripts where photographs of either gels or plant materials were used twice or three times in the same manuscript. These manuscripts were immediately rejected.
However, we are not convinced that these are cases of deliberate misleading of the scientific community. It rather seems to us that many laboratories consider photographs as illustrations that can be manipulated, and not as original data. Thus gels are often cleaned of impurities, bands are cut out and photographs of plant material only serve to show what the authors want to demonstrate, and the material does not necessarily originate from the experiment in question.
When the editor-in-chief rejected such a manuscript, a typical response was: “I am surprised by the question and problem you pointed out in our manuscript. I checked the pictures you mentioned and I agree that they are really identical. But please be reminded that the purpose of these gel pictures was only to show the different types of banding pattern, and the gels of a few specific types were not very clear, so my PhD student repeatedly used the clearer ones. This misleading usage does not have an influence on data statistics or the final conclusion”.
Question(s) for the COPE Forum
What can be done to ensure that all gels and all photographs originate from the experiment and that they should never be tampered with?
How can the scientific community of some particular countries be taught correct scientific publishing standards?
The advice from the Forum was for journals to strengthen their guidance on this issue. Journals should provide clear guidelines in their instructions to authors on what is acceptable. Original data, such as gels, should not be used as illustrations, without an explanation. Line drawings, for example, can be used to illustrate a point, but if original data are being used just to illustrate a point, this should be accompanied by a very clear statement in the manuscript telling the reader this and explaining what is being demonstrated.
The Forum advised looking at the guidance published in other journals. Some journals have very good guidance on this issue and editors may wish to incorporate such guidance into their instructions to authors (with full attribution and after obtaining permission).
On a poll of the Forum, less than half of the delegates said that they screen for image manipulation. COPE has an eLearning module on image manipulation. Also, Mike Rosner has written extensively on this topic (Journal of Cell Biology 2004;166:11–15 http://jcb.rupress.org/content/166/1/11.full)
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?
The Forum was told that the editor has not yet contacted the authors of the meta-analysis. The advice from the Forum was to raise the concerns with the authors initially. The editor has a responsibility to act on the information that he has, and the first thing to do is contact the authors of the meta-analysis.
The editor also needs to be sure that the evidence from the expert is sound, regarding the fact that some of the papers in the meta-analysis are fabricated or heavily plagiarised, before he draws any conclusions. The Forum suggested gathering more opinions on the meta-analysis and perhaps eliciting help from members of the editorial board. Why was the paper accepted in the first instance? Did the reviewers suspect anything untoward with the paper? The editor should go back to the reviewers and ask their opinions and also ask their advice on the response from the key expert.
The Forum cautioned against the practice of blindly re-analysing data for inclusion in a meta-analysis, without obtaining the original data, so the authors of the meta-analysis need to take some responsibility here.
Unfortunately for the authors, their paper is in limbo while there are questions over the paper. One suggestion was to ask the authors to re-do the meta-analysis using only the data that are not under suspicion.
Ultimately, it will be up to the journals in which the primary studies were published to investigate the fabricated and/or plagiarised papers, but journal A should initiate the investigation by contacting these journals. It will be the responsibility of the other journals to see that an investigation is carried out but journal A should follow the events. Of course, if the other journals refuse to investigate, there is little that the editor can do.
In summary, the Forum agreed that the editor should contact the authors and the reviewers of the meta-analysis in the first instance. If the editor has sufficient evidence that some of the papers are fabricated or heavily plagiarised, he should then contact the journals where the primary studies were published and ask them to investigate.
The director of a research laboratory contacted our journal regarding an article published earlier this year. The director claimed that the documents and data used in the article were collected at his research laboratory and used by author A without his knowledge and permission.
At the time, author A was a visiting scholar at the director's laboratory. The director also claimed that author B and author C (both PhD students under the director's supervision) were listed as coauthors without their knowledge. Additionally, he claimed that author D (author A's supervisor at his primary affiliation) was not in any way involved in the research described in the article and should be removed from the authors list. The director stated that he wishes for the article to be withdrawn.
In his email to our journal, the director forwarded us his previous correspondence with author A to corroborate his claims. In their correspondence, author A basically admits his mistake, apologizes and assures the director that he already contacted our journal in order to withdraw the paper. The correspondence between the director and author A occurred approximately 3 months before the director contacted us. Our journal never received a request to withdraw the paper from author A.
However, even though the forwarded correspondence clearly incriminates author A, as far as we know it is not possible to determine whether the forwarded emails are authentic or edited.
After receiving the director's message, we contacted all of the authors in an attempt to resolve the case. At the time of submission, author A was affiliated with institution 1 and institution 2. Author D is affiliated with institution 1, while author B, author C and the director are affiliated with institution 2. Author A stated that he included author B and author C as coauthors due to their help with language editing, but he agreed with their request to be removed from the authors list. When asked to comment on his previous correspondence with the director, he claimed in vague terms that the misconduct allegations stem from some personal disagreement between the director and author D during their collaboration on a research project.
Author B requested his removal from the authors list as well as withdrawal of the article. Author B also claimed that some of the data in the article were not valid. He did not respond to our request to clarify in what way were the data were flawed. Author C requested his removal from the authors list as well as withdrawal of the article. Author D was contacted a week later than the others due to a faulty email address. We informed him that author B and author C expressed that they wish to be removed from the authors list and he agreed with their request.
As all of the authors have reached a consensus regarding authorship, we intend to correct the record and remove author B and author C from the author’s list.
The director was asked if he could provide some other proof of his allegations besides the forwarded email correspondence between himself and author A. He did not provide any other proof and demanded that the article be removed at once and that author A's institution (institution 1) be notified of his scientific misconduct. Additionally, he claimed that author B performed the majority of the research presented in the article as author A had insufficient experience in the field.
Author A was asked to comment on that claim, but he maintained that he wrote the article and did not use data collected in the director's research laboratory.
We do not have the means necessary to pursue further investigation of this case by ourselves, which is why we are seeking advice from the COPE Forum.
Questions for the COPE Forum (1) Should the forwarded email correspondence between the director and author A be considered conclusive evidence of alleged scientific misconduct on author A's behalf? (2) Should we retract the article based on the scarce information we have managed to gather? (3) Should we first publish a correction in order to rectify the misattributed authorship and deal with the data ownership issues separately? If so, should we try to further resolve the data ownership issues ourselves or refer the case to author A's institution? (4) Should we publish an expression of concern detailing the alleged misconduct, inform author A's institution about the allegations, request an institutional investigation and wait for the results of their investigation before making a final decision about this case? (5) Does the COPE Forum have any other suggestions on how to proceed with this complicated case?
The Forum agreed that the editor has reached the point where he cannot investigate this further or hope to resolve this issue, and hence he should now contact the authors’ institutions and ask them to investigate the matter. The Forum suggested contacting both institution 1 and 2, providing them with as much information as possible. The editor cannot resolve the issue of who owns the data. As the editor has concerns about the article as it stands, it was suggested that he publish an expression of concern, alerting the readership that there may be problems with this paper. However, others cautioned about the timing of publishing an expression of concern—should the editor wait until after the investigation by the institutions? On polling the Forum audience, the majority agreed that they would wait for the results of the institution’s investigation. However, the Forum reiterated that this must be an editorial judgement, taking into consideration whether the editor has a reasonable expectation that the institution will investigate the matter in a timely fashion.
The Forum suggested the editor might like to consult the COPE retraction guidelines for guidance on when to issue an expression of concern.
Unauthorized use of data came up as a prime issue in a recent study of the re-classification of the COPE cases in the past 10 years. Also, the Montreal statement on research integrity in cross boundary research collaborations came out of this year’s World Conference on Research Integrity (http://www.wcri2013.org/Montreal_Statement_e.shtml), and this statement addresses these types of issues. Editors may wish to refer authors to their guidance.
After efforts to investigate the alleged misconduct had failed, the journal referred the case to the institution where the misconduct reportedly occured. The editor was subsequently informed that the reported issues had been discussed internally and that it was ultimately decided that no further action or investigation would take place.
Since there is no conclusive evidence of misconduct, the journal will not be taking any action with regards to the issue of allegedly unauthorized use of data. However, action will be taken to rectify the reported and confirmed authorship issues.
A manuscript was published in journal X, submitted by several co-authors, including one of the editors in chief of journal X, Dr A (the article was handled by another editor in chief at the journal). Another researcher, Dr B, has claimed that this article should be withdrawn because it contains unauthorized data from him (Dr B).
A few years previously, Drs A and B worked and published jointly, but at some point there appeared to be a divergence in points of view on the interpretation of results (obtained in a large part by Dr B and his team) in a manuscript co-written by both Drs A and B (and the teams of both Drs A and B). Dr A decided that Dr B and his team must agree to the publication of the manuscript or they would be removed from the co-author list. The paper was then submitted as an appendix in an internal report for their funding agency.
Later, a similar paper was published by Dr A and his team (only) with similar content to the previous disputed paper in journal X. Dr B and his team are acknowledged in the text but have not been asked or listed as co-authors. The paper contains the results from Dr B’s team, very important results, that people now refer to as from Dr A’s team.
Dr B thinks this is a violation of the rules of good scientific practice and has asked advice from a third independent party. The third party recognized the violation of the rules of good scientific practice and suggested publishing an erratum. Dr B refuses to agree to an erratum because his team do not necessarily wish to be co-authors, as they disagree with the interpretation. Dr B wishes to have this published article withdrawn.
Question What should the editor of journal X do?
The Forum agreed that the current paper cannot stand in its present form—some form of correction of the literature needs to be done. It is clear that the data are the intellectual property of Dr B, but this is essentially an authorship dispute, and it is up to the authors to resolve it. Although the results of the paper are not in dispute, the editor could decide to retract the paper and tell the authors that they must resolve their dispute themselves. So the editor could present the issues to both authors and tell them that some form of drastic action might happen if they cannot resolve the issue and ask them to find an independent arbitrator whose decision they agree to abide by. As a third party is already involved, would both authors agree to abide by the decision of this third party, given that it was author B who asked for advice from this third party? A better solution might be for the authors to agree on another independent party who could arbitrate on the case.
But if the authors cannot come to any agreement, the editor could suggest that author B is allowed to write a letter or article explaining his interpretation of the results.
One other suggestion was to have a revised paper, with all of the authors listed, and with two separate discussions. The readers could then make up their mind which interpretation they preferred. However, the original paper would have to be retracted.
The majority agreed that the best way forward was to present the issues to both parties and tell them the journal is prepared to retract the article unless the authors can resolve the case.
The editor had further communications with Dr B. The editor again explained that it was not the journal’s decision to make but was up to Dr B, his employer and the authors to sort out. The editor has now stopped corresponding with Dr B.
A sixth year medical student, with expected year of graduation of 2013 (Mr X), submitted 29 original articles and 17 letters to the editor in the period February 2012 to October 2012 to our journal. This amounted to an average of five submissions per month. Mr X is an author and corresponding author in every article. Of these, he is the first author of eight original research articles and 12 letters. In the remaining one he is a co-author. The articles are on very diverse subjects.
This set us thinking that, apart from his clinical work and studies, how he had time to conduct research, analyse the results and write the articles.
The journal first wrote to Mr X for the necessary justification. He responded promptly, “I am one of the best researchers of my country and have multiple publications in every field of medicine and have won multiple prizes”. He provided a list of 72 publications to his credit. He also provided the name and email of the chief of the research committee of the university.
We wrote to the concerned parties asking them to endorse the submissions as being ethical and valid for the purpose of publication. The chief replied that Mr X was a member of the student research committee with some research background in medicine which led to multiple awards and publications. He confirmed the research background in a vague manner and there were no more comments or endorsements of the submitted articles.
We then wrote to the vice chancellor of the university asking for verification and endorsement of the articles according to the ICMJE guidelines. The director of research affairs was also approached, who asked for details of all the articles submitted. These were duly sent.
In the meantime, Mr X contacted us stating that his e-mail had been hacked and someone else had sent letters and articles with his name. This was incorrect, as all mails had the same e-mail address. We also sent an email to the Publication Commission in our country on 6 March 2013. There has been no response.
We face a dilemma. The articles are lying unprocessed. It is a mystery as to why the higher authorities are not taking any action or replying to our emails.
Question What would the COPE Forum suggest we do?
The Forum suggested that it may be useful in this case to help rather than punish the author. As an initial approach, the Forum asked if there was any pastoral care available to the student, or whether the medical school has anyone who could talk to the student in a confidential manner. This may be more of a problem with the student, rather than research integrity concerns. The institution has a responsibility to its students and they need to ensure that students are sufficiently supported. So the editor should consider contacting someone in this role at the author’s university.
However, that still leaves the dilemma of the unprocessed articles and what to do with them. The Forum advised that the editor needs to be certain that the articles are all from the author and that he takes responsibility for them. If there is any doubt, then the articles should not be processed. However, if the articles are genuine and have scientific merit, then they should be processed in the normal way, as there are no grounds for rejection.
The Forum also suggested contacting any co-authors on the papers for an explanation and to confirm that the papers have all been written by the author. The editor should make it clear to the author that the papers are on hold while the issue is satisfactorily resolved.
Another suggestion was for the editor to consider contacting some higher authority or regulatory body, or ministry of research, and asking them to investigate the case.
As suggested by the Forum members, we did some investigations ourselves as the higher authorities, including the Vice Chancellor of the University to which the author belonged, were unresponsive.
As a sample, an Internet search was made for three of the articles. One was found to be copied in full from a similar article in another online journal.
A search was made for the correct names and email addresses of the coauthors, as those stated in the articles submitted to us were wrong. We spoke to two coauthors by telephone— one knew nothing about the concerned author or about his name being included as a coauthor. He also knew nothing about the article. Another senior coauthor spoke in favour of the author. He said, “ Mr X is a very intelligent and knowledgeable researcher and writes very well”. He could not justify how Mr X could write on such diverse topics.
We received only one email reply from a senior professor. He wrote : “I was really shocked to see the paper published without my knowledge. I do not know Mr X (author). I have never met him. He has never worked with me. He has stolen my published data. I am going to forward this message to the ethics department and make a complaint on the concerned person at the university”.
We have had no comment or reply to our queries from the officials of the university. From the Internet searches made by us, we can conclude that Mr X, the medical student (author) is: • Not only good at writing in English but is also excellent in fabricating and stealing data. • He has the support of one or two senior faculty members of his university. • He has been committing these unethical acts for quite a few years as there are a number of articles with his name. • The articles submitted to our journal had fake email addresses and names, even with incorrect spellings, making contact difficult. • The signatures of all authors were forged.
Questions for the COPE Forum (1) Should we just close all the files and bury the case? (2) If not, what steps should be taken?
Advice on follow up:
One view from the Forum was that, as suggested before, the editor should contact a higher authority, regulatory body, or ministry of research, and ask them to investigate the case, given the institution’s unwillingness or inability to engage with the editor on this issue.
However, others argued that it is the responsibility of the institution to deal with this student. Institutions not responding to editors’ requests is a common problem, and the advice was to contact the institution every 3 months, requesting a reply and including copies of the information on the case. The editor should say that he/she does not consider the matter closed and request that the institution investigate the case. If the institution does agree to an investigation, the editor should publish the findings of the investigation in the journal, using the text from the institution’s report.
The Forum advised the editor not to accept any more papers from this author. The editor should write to all of the authors of the submitted manuscripts to say that no further papers will be considered from this student.
Regarding the published papers, the editor should consider contacting the editors of the other journals that published papers by this author.
Update (December 2013): The Secretary National Ethics Committee updated the editor that the university was conducting an investigation. The Committee have confirmed that more misconducts had been detected against this author and the concerned authorities were still looking into the case. The Committee suggested that the journal should take an independent decision on the unprocessed articles in the journal’s office. The journal plans to make a final decision on the pending articles very soon.
Update (February 2014):
The Secretary National Ethics Committee told the editor that more misconduct cases had been detected against this author and the concerned authorities were still looking into the case. He suggested that the journal should take an independent decision on the unprocessed articles. We will make a final decision on the pending articles shortly.
Update (June 2014):
The decision of the editorial board of our journal was to close all 27 pending files on the grounds of fraud. The decision was also taken to debar the author. The Secretary National Research Ethics Committee of the author’s university was informed.
In October 2011, our journal received a submission from author A with co-authors B, C and D. After review and revision it was published in mid-2012. In April 2013 we received a complaint from author X, saying that the work published in this paper was his work, and that although author A had been his research supervisor at the time the work was done, authors B, C and D had either little or no input to the work. Author X said that the correct authorship should be X and A in that order.
Author X provided as evidence an internal document submitted to and accepted by the university authorities in May 2010 in fulfilment of a requirement to demonstrate capability for research. His academic record confirms that this submission was successful. He then changed supervisor (and department) within the same university due to a breakdown of relations with his previous supervisor, and proceeded to complete his PhD in January 2013. The internal document is not in English, but it is apparent that close to 75% of the content of the journal paper has effectively been taken from the internal document. [This has been checked roughly through the use of online translation. The majority of figures and diagrams are clearly the same. The authors (A–D) of the published journal paper do not appear to be contesting that this document was the source of the text although they claim ownership of the data and ideas.]
When challenged, author A says that author X was a poor researcher and was away from the country for considerable periods of time when he should have been doing the work. He also suggests that others in his research team gave author X considerable help with the internal document. He claims that author X has fraudulently used the work of author A and his co-workers, both in the internal document and in his PhD thesis.
The editor’s suggestion was that author X’s name should be added to the authors of the published paper, as second author (compromising on the initial request of author X that he should be first author, given that author A was the team leader, had a strong interest in the work and that this complaint had come nearly 3 years after author X had departed the group, amid some acrimony). This would be achieved through the publication of a corrigendum. Author
A disagreed strongly, and said that he did not wish his name to be on the same paper as author X’s. Author A also encouraged the other co-authors to respond, and they supported him. The original authors said they would rather withdraw the paper than have author X’s name added.
The editor indicated that withdrawal (retraction) of the paper was not an option at this stage, as no one had questioned the science in the paper, and the concern was solely over the authorship. The editor also pointed out that the guidelines on authorship, available through the journal’s web page, made clear that anyone who has made a significant contribution to the article should be included in the list of authors. The prior existence and acceptance by the university of the internal document as proof of the research competence of author X would appear to be sufficient proof of a significant contribution. This would not apply if there had been some formal challenge within the university, but no challenge appears to have been made.
The current head of department of author A has largely confirmed the picture painted. He says that when author X first came to the department he was announced by author A to be a ‘brilliant student’, but that relations started to break down early on, as author X had expected to do research in a somewhat different area. He confirms that after the internal document had been submitted and accepted, author X moved to complete his PhD in a different department, although in the same general area as before. He agrees with the proposed action and says he will attempt to convince author A, but with no feedback as yet.
Questions (1) Can the journal make a decision to add author X’s name without the agreement of the other authors? Given the opinions that authors A, etc, have so forcefully stated, this seems inappropriate. (2) Could a corrigendum be used to demonstrate the full order of suggestions—that author X be added, that authors A, B, C and D said that if that were decided they would withdraw their names, and therefore the paper would now be acknowledged as the work of author X alone? (3) Should the request of author A and others that the paper be retracted be accepted? This appears entirely inappropriate as no one is objecting to the science or claiming that the work should not be published on scientific grounds?
The Forum agreed that it is not up to the editor to decide who is an author on a paper. The editor is not in a position to know the details of the dispute. This is the responsibility of the authors and their institutions and needs to be resolved by them or by an independent party. However, the paper is unacceptable as it stands, and the editor should put a note on the paper saying that the authorship is in dispute. The editor might even suggest that the institution has been unable to resolve this dispute. This may prompt the authors or institution to resolve the issue. The editor could suggest to the authors that they find an independent arbitrator to review the case and whose decision they agree to abide by. Another suggestion was for the editor to suggest including author X on the paper, and then giving the other authors the option of withdrawing their names.
The editor told the Forum that, subsequently, the head of department has suggested that author X should be listed as the second author on the paper and author A seems to accept this. If this is the case, the Forum advised the editor to emphasise on the correction notice that the paper is being corrected on the recommendation of the institution.
Since the case was discussed, the editor has focused on getting the institution to take full responsibility for taking a decision. This has been effective to the point of getting all parties to indicate they would accept the decision, although on circulating the proposed corrigendum, the first author (A) reverted to saying that author X was not acceptable. The institution stuck with the decision, and the corrigendum will appear shortly.
In 2008, our journal published a phase 2 randomised controlled trial of a new medicine. In 2011, the regulatory authority in the country where the study was performed decided to undertake routine monitoring of completed studies and this trial was selected for random inspection. The author informed the journal of the inspection and provided a translation of the report (independently verified as accurate by our journal).
The following concerns were raised by the regulatory authorities: (1) There was no medical involvement in the process for informed consent, which was delegated to a non-medical practitioner. The country’s regulations require that a medical practitioner informs a participant and confirms this. The local ethics committee has been informed by the regulator about this lapse. (2) The integrity of blinding was questioned in an earlier inspection in 2007 and because of comments about the treatment’s efficacy and side effects by one of the investigators while the trial was underway. (3) The recording and assessment of adverse events was incomplete and the inspectors felt that the table of adverse events published in our journal did not reflect the clinical records for product safety.
The manuscript had two rounds of peer-review (seven reviews by four clinicians and a statistician). The only point of relevance to the above concerns was the comment that “the main weakness of the study is inadequate data on safety and adverse effects (in part unsurprising as this was a proof of efficacy study) and a rather overly positive presentation of the data”. The manuscript was revised and re-reviewed by this reviewer and a statistician; both were satisfied that the points had been addressed in the revision. After publication of the research article, our journal published two letters as correspondence. In one, the possibility of certain adverse events was raised, to which the authors replied that these had not been observed.
The authors have submitted a correction that states incorrect instructions by the contract research organisation resulted in under-reporting of adverse events for headache, migraine, stress and depression in people who had experienced these conditions before enrolling in the trial. They also state that comments about the medicine made to local media were based on another study. The editors are concerned that taken in their totality, the issues raised by the regulator question the soundness of our publication. As we gather more information and await the ethics committee’s decision about the process for informed consent, the editors would be interested in learning what actions COPE would recommend.
The Forum advised that if the editor cannot decide what to do, a statement of concern could be published in the interim. If the editor thinks the methodology was insufficient (to detect side effects), then he should consider retracting the paper. Clearly a correction needs to be done. The expression of concern should mention the fact that the table of side effects may not be correct, in addition to the issue relating to consent. The editor told the Forum that he does not believe there has been any misconduct and the authors wrote the paper in good faith. On a show of hands, nine people suggested that the editor should do an expression of concern detailing the chain of events. Only two people thought the paper should be retracted. Hence the consensus was that it would be appropriate to put a statement of concern on the paper.
The journal has received a letter from the author that responds to the expression of concern and the inspection report. At present, the precise wording is being negotiated with the author.
Update (September 2013):
The journal published an expression of concern and a letter from the authors that responded to the expression of concern and the inspection report. Although there was insufficient evidence to retract the publication, the editors felt that uncertainties about the study persisted and therefore decided that the expression of concern should remain part of the published record.
Following publication of an article, a reader posted a comment raising some questions about the data analysis in the study and the availability of the dataset. We followed-up with the authors and they offered to share the dataset with the reader—the dataset involves genetic information from potentially identifiable patients and as a result the authors indicated that the deposition of the data was not possible due to patient privacy concerns. After several months the reader indicated that he had not received the dataset from the authors and that he had discussed the study with a member of the editorial board who shared the concerns about the reliability of the results reported. We further followed-up with the authors to reiterate the request for the dataset and they made the dataset available to the editors and the reader.
The reader has re-analyzed the datasets provided by the authors and he indicates that his results do not support the conclusions reported in the article. The re-analysis has been evaluated by the editorial board member who previously commented on the article and he agreed that the reliability of the findings in the article is compromised by the results of the re-analysis. We asked the authors to provide a response to the results of the re-analysis and we indicated that, in the light of the concerns raised, it may be necessary to consider retraction of the article. The authors have replied and offered to collaborate with the reader in further analyses, however they suggest that the differences in the results may be due to the different methodologies employed for the analyses and they have not formally agreed to retract the article.
We have offered the reader to submit his re-analysis for publication but he is not interested in doing this; he is however willing for us to make his re-analysis publicly available via a public notification on the published article if we decide that such a notification is necessary.
In the light of the concerns raised about the study, should we post a formal public notification on the article in order to alert readers of the concerns about the validity of the findings? If so, would it be appropriate to proceed with a retraction or given that the authors have not agreed to this, consider instead the publication of an expression of concern?
The Forum suggested that a better course of action would have been if the editor had asked the authors for their comments on the re-analysis, and then submitted the results of the re-analysis and the authors comments to an independent expect to review.
Although the reader is happy to have the re-analysis attached to a commentary, this will not be formally indexed or linked to the original article. The Forum agreed that ideally, the reader should publish the re-analysis. The suggestion was for the editor to try to persuade the reader to publish the results of the re-analysis. Getting the re-analysis published formally is the best option. If the reader still refuses to publish, then the editor should ask the authors to respond to the re-analysis and then ask an independent reviewer to look at all of the data and then publish this as a comment on the article itself.
In the light of the advice provided by the COPE Forum, the editor followed-up with the reader and he has agreed to submit his re-analysis for publication. The editor is awaiting the submission of the piece describing the re-analysis.