In November 2014, the first author of a decade old paper in our journal and a 15-year-old paper from another journal informed us that he faked the data in two figure panels in the paper in our journal and one figure panel in the paper in the other journal. The main gist of the manipulation was loading unequal amounts or delayed loading of gel lanes.
Self-admission of data falsification is a serious charge that is difficult to disprove, and we felt a challenge to identify evidence to counter or support this type of allegation. As general guidelines, we felt there were three types of evidence that could help resolve the standoff: (1) compelling original raw data with evidence for or against unequal or delayed gel loading; (2) verified replication already existing within the published literature; and (3) as a last resort, a replication study performed by a wholly independent laboratory.
In December 2014, we asked the first author to contact the corresponding author of both papers and the institute, but he refused. We informed the first author that we would inform the corresponding author of the papers and this might result in violating his confidentiality. In January 2015, we informed the corresponding author that we had received self-admission of fraud from the first author and asked the corresponding author to retrieve original raw data for the figures in question and provide them to us. We also urged the corresponding author to engage the institute ethics committee and get in touch with the first author in gaining a deeper understanding of the challenges.
In February 2015, we spoke with the corresponding author by telephone. The corresponding author did not believe that the first author had faked the data. We discussed potential ways to counter a compelling self-admission and agreed that the corresponding author would provide us with the raw data by the end of March 2015 and would inform his institute.
In March 2015, we were contacted by his institute. On request, we provided the contact information of the first author to the institute’s investigation committee after obtaining permission from the first author. The corresponding author told us that he has located all of the raw data. In contrast with what we agreed by telephone, he told us that he would not be sending us the raw data directly but would pass them to the committee. The first author provided both us and the committee with data that he said was contemporaneously produced and showed a different result from what was published, that he said was without manipulation with gel loading and showed no experimental effect.
In April 2015, we asked the committee to share their investigation results with us and also asked the corresponding author to provide the copy of the raw data to us. But the corresponding author and committee refused to share any useful information with us. The committee told us by email that they have an obligation to protect the corresponding author’s reputation.
In May 2015, we spoke with the research integrity officials of the institute by telephone and they agreed to share more information with us. In early June 2015, we received a summary but not the full version of the committee report, which cites that no further action is warranted because the evidence they gathered can neither support nor refute the first author’s self-admission. We were not provided with any of the original data. The summary report included information such as promotion schedules of both the first and corresponding authors, but these seemed irrelevant to us. We felt it essential that we have access to the full scientific information on which the committee based its recommendation.
In late June 2015, the institute shared with us the full report of their investigation. We were able to understand from this that their conclusion that no further action is warranted was based on the fact that there was no recorded falsification in the laboratory notebook. We feel this reason is not sufficient to counter self-admission of fraud as someone who intentionally fakes data would not likely record it in their laboratory notebook. We therefore were unsatisfied with recommendation to take no further action.
In July 2015, we interviewed the first author via Skype and asked him to describe again how he generated the data and how he intentionally manipulated the data to fake the results. What he described over Skype was consistent with what he has described to us in previous correspondences.
In July 2015, we also spoke with an institute senior official and explained again that only contemporaneous data collected by the first author, contemporaneous data collected by other members of the laboratory, or direct replication of the data by an independent laboratory reported in the published literature would be necessary to counter the first author’s self-admission of fraud. Since none of these avenues turned up evidence to counter the self-admission, we suggested that the experiments in question could be independently repeated by a third party or the paper will need to be retracted.
In August 2015, the corresponding author agreed to proceed to have the data in question independently repeated by a third party. We are now instructing the corresponding author to reach out to a laboratory to start repeating the experiments. While he agreed in principle, the corresponding author is dragging his feet and we are uncomfortable sitting on a serious allegation and eager to move forward with a resolution in a timely and responsible manner.
Question(s) for the COPE Forum • What are COPE's recommended procedures for handling self-admissions of fraud? • What is the journal’s responsibility when one author self proclaims fraud and another author says no fraud occurred? • What is the responsibility of the journal if the journal thinks an institutional investigation was not evidence based.
The Forum noted that this was a very unusual case, both fascinating and alarming. At its heart it would appear to an authorship dispute, and the journal was correct in involving the institution. The Forum suggested contacting all of the authors and asking for their input. It would seem that the only clear way of resolving the issue is to replicate the study and try to reproduce the results.
The Forum questioned why it has taken the corresponding author 10 years to contact the journal, as it would seem to be professional suicide. The Japanese government has recently issued guidelines to institutions to clean up their act following the Japanese stem cell scandal—could this be a factor?
The Forum acknowledged that the journal has handled this correctly by taking the allegations seriously. The Forum suggested publishing an expression of concern. The expression of concern should be worded in a neutral manner without apportioning blame or accusing the author. This also may prompt the corresponding author into action.
The Forum suggested continuing to work with the corresponding author to replicate the study. The only way to resolve this completely is to try to replicate the study, and it is in the interests of the corresponding author if he wishes to stand by his allegations. The journal does have a responsibility to pursue an independent investigation if the journal thinks the institutional investigation was not evidence based. The journal should give the corresponding author a time limit, after which the journal should review the situation and either amend the expression of concern or retract the paper.
The journal has published an expression of concern and will keep readers updated when the results of the investigation are available.
Follow up (October 2016):
The journal has now published two editorial expressions of concern and followed up with two editorial notes, explaining that the results of the independent investigations were inconclusive. The editor considers the case closed.
In 2014 we received a communication from the Research Integrity Officer of an academic institution informing us that a paper, published in our journal in 2013, included falsified or fabricated data. We were informed that, following an investigation, they had determined that scientific misconduct had occurred.
Within a few days we received a communication from one of the authors of the paper (who is no longer at the institution) reiterating this assertion and providing some further explanation; that a former student had fabricated data and that it affected the paper (but providing no specifics).
Over the next week or so, other journals by the same publisher received similar notifications from the same author. Initially, we were presented with no information regarding who the perpetrator was or the specifics of the affected data. We were therefore unable to determine how severely affected the validity of the overall paper was and whether a retraction or correction was necessary.
Our initial response was to request further information from the institution and the author. Initially, we were informed by both parties that, as a result of Federal privacy laws, they were unable to divulge any details pertaining to the investigation, aside from what they had already told us. In the meantime, we decided to publish an expressions of concern on all four papers affected by our publisher with identical notices detailing what we knew for certain and stating that we would seek further details from the institution.
Sometime later we heard back from the institution providing further specific information (ie, outlining the fabricated data) for three of the four papers. Of these three papers, two are now in the process of being retracted, while an academic editor has been consulted to advise on whether the third should be retracted or corrected, based on the additional scientific information now available.
However, in regard to the fourth paper, published in our journal, we were told by the institution that no further information was available. The author who contacted us has not provided any specific information either. Therefore, we find ourselves unsure of how to proceed next, as we still do not know to what extent the conclusions in the paper are valid.
Question(s) for the COPE Forum • Should we proceed with a retraction but simply state that we cannot provide further information (something we feel is unsatisfactory for our authors)? • Should we instead leave the expression of concern online but update it to say that we will not be able to provide any further information? • Does the Forum have any other suggestions?
The Forum asked the editor if the paper had been handled through the Office of Research Integrity (ORI) in the USA, as they post their findings on cases on their website. However, the laws related to the ORI are very strict and do not allow sharing of information, even with institutions, and so the only way of finding out any information is to look at what has been published in the federal registry. The editor told the Forum that there was no information on the ORI website.
One view was that, given the history of all of these papers, and the concerns about the data on this particular paper, the editor should err on the side of caution and retract the paper.
However, a more cautious approach was also suggested. COPE would advise that a retraction statement should be as informative as possible; a journal needs to give its readers a reason for the retraction. Hence, in the absence of further information, the editor may consider not retracting at the moment, but instead updating the Expression of Concern. The editor may want to explain that other papers have been retracted as a result of the same investigation but no further information is available on the current paper.
Another suggestion was to go back to the institution and insist that they provide further information on the validity of the data.
Advice on follow up:
Following the discussion at the Forum, the editor decided that there was insufficient information available to support a retraction. Therefore, the current Expression of Concern remains on the record pending further communication from the institution concerned.
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.
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.
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.
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.
To avoid a similar situation in the future, the Forum advised the editor to tighten the journal’s instructions to authors and request the contact details of all authors, not just the corresponding author, on submission of a paper. The Forum agreed that it is difficult to deal with the second paper until the issues with the first paper have been resolved, particularly as there is no evidence of misconduct in relation to the second paper. The advice was to contact the ethics committee or institutional review board in relation to the first paper, or if a response from the institution is not forthcoming, consider contacting any professional bodies the author might be a member of or the funding body. The editor might consider contacting any collaborating institutions listed on the second paper.
Despite a further letter to the university in question, the editor has not yet received a reply. The editor was given the email address of the head of the academic department from the author of the second submission. No response has been forthcoming. The editor is not aware of other bodies who could be contacted to shed light on the matter. The research project was funded internally.
The journal’s Guide for Authors has been updated and authors are made aware that extra information can be requested by the editors. Should the journal receive further submissions from this institution, they will receive thorough peer review and if there is any doubt as to the validity of the data, the journal will seek clarification from the authors.
Author A has published approximately 150 original articles since ~1994, with ~100 on one particular topic. Since some of these events were up to 16 years ago, and there are no formal records from then relating to these studies, the only information we have is the memory of the editors of the affected journals in post at the time. According to their accounts, suspicions were aroused over the validity of the data, in particular the similarity between baseline data of some of the different studies. When author A was pressed to provide raw data, he stopped responding and stopped submitting papers to the specialty journals, switching to general journals where he continues to publish. The editor of one specialty journal raised concerns with the author’s institution (in another country) approximately 12 years ago; it responded saying it saw no reason to investigate further. A letter, published in one of the specialty journals in 2000 by an independent researcher, asked the question “Why are author A et al’s data so nice?”, pointing out that the probability of such results occurring by chance were infinitesimally small, but as far as we know there have been no formal investigations of author A’s work
Following an April 2010 editorial in one of the specialty journals about research fraud in general, that mentioned this particular author by name, a correspondent raised the lack of investigation into author A, stating that his update of a systematic review was being hampered by the (suspect) influence of author A’s work in this area. The current editor-in-chief of that journal contacted the current editors of seven other affected specialty journals, who until this point were largely unaware of the problem, or its extent, having not been in post at the time the papers were submitted to their journals. We have since been discussing the problem and possible courses of action. The points raised are:
(1) Regarding the older papers:
(i) the journals themselves do not have the ability to mount an investigation;
(ii) it is unlikely that an investigator, bona fide or not, will still have original data from the older studies;
(iii) it is unlikely that author A’s institution will be interested in investigating studies so old, and we think he might have moved universities since then;
(iv) currently we do not have any firm data of wrongdoing, just suspicions. Options for gathering more data include asking the original correspondent and the systematic reviewer to provide a more formal commentary, although we have not done that yet. Meanwhile, one of the editors has gathered data on all author A’s studies: there are 135 in which author A is the first author, reporting almost 12,000 randomised patients in 17 years. Most are with one of the same three co-authors. The largest group of papers (by topic) are all very similar in design, with very little variability in baseline placebo event rates, and generally similar results although the outcome measures differ and there are one or two ‘surprising’ (at best) findings. One particular drug features in 71 studies. Dropouts are hardly ever reported.
(2) Regarding the newer papers:
(i) these may be easier to investigate since the data should still exist;
(ii) we could contact the editors of the non-specialty journals (there are many, publishing just 1-2 of A’s articles each) to alert them but the problem of having only suspicions remains (compounded by the relatively large number of journals, each with a small number of papers);
(iii) we could ask a respected academic in author A’s country to make discreet enquiries of author A’s co-investigators, some of whom may not realise what is going on, or they may have concerns themselves. However, this could be a delicate situation for such a person. We would welcome COPE’s advice on how best to proceed.
The Forum was unanimous in their opinion that this should really be resolved by the researcher’s institution. Although there is no hard evidence, it was suggested that all of the journals, as a team, approach the institution and ask the institution to conduct an investigation. It was felt that this would provide a more powerful case than a single editor on his own. Meanwhile, the editor should try and gather more evidence, perhaps by contacting the ethics committees who supposedly approved these studies. The editor may then be able to determine whether in fact the studies took place as reported. The Forum advised against informing the non-specialty journals at this point as there is no real evidence at this point, so it would be difficult for them to know what to do. The Forum also suggested that the editor should advise anybody doing a meta-analysis on this subject to include a sensitivity analysis to test the effects of including the data from these studies.
The group of editors-in-chief are planning on sending a letter to the author and the institutions. The delay has been in obtaining an independent analysis of the suspect works, which so far indicates that the likelihood of fabrication is very high.
Follow up (May 2011):
The editors are still planning on sending a letter to the author and the institutions but this has been delayed pending the analysis, which has now been submitted to journal A for publication! (It concludes that fabrication is almost certain.) Meanwhile, a separate publication scandal has distracted the editors’ attention recently.
We did not investigate ethics approval since we felt that should be for the institution to investigate. My main question is what to do with the analysis that has been submitted:
(i) process as usual and publish if accepted (after discussion with/approval by the publishers); that is, let the author/institution respond if they wish (ii) present it to the suspect author (with the analyst’s permission) and remove from the publication process for the time being (iii) present it to the suspect author’s institution(s) as per (ii) (iv) present it to the suspect author and institution(s) as per (ii)
I have sought an independent statistical review of the analysis from a respected statistician but have not had a response.
Advice on follow up:
There were various views on how to proceed in this difficult case. Some agreed with sending the analysis to the institution and the suspect author, at the same time, informing them that the intention is to publish the analysis in the journal, and then see what type of response this elicits. Others disagreed and recommended treating the analysis like any other submission (despite the fact that the review was commissioned by the journal and the editor hadn’t originally intended to publish it) — send it out for peer-review and publish it in the normal way. Most agreed that a copy of the analysis should be sent to the institution, either before or after peer-review. But the paper does not need to be peer-reviewed before it is sent to the institution.
The Forum also advised consulting the journal’s legal department before going ahead with publication.
A published paper has been under legal scrutiny due to fabricated data. The court has concluded that the evidence presented undermined the credibility of the study. We have read the COPE guidelines for retracting an article and have checked the flowchart 'What to do if you expect fabricated data'. From reading the guidelines it seems that the editor has the right to retract the paper and to do this promptly. However, because we have not had a case in which a paper has been discredited through a civil court process before, we would like to seek the advice of COPE before we ask for a retraction.
The case in more detail:
• 2006: journal publishes paper that explores the link between two drugs, A and B and vision loss.
• 2006: the drug company responds in a published letter, pointing out flaws in author’s case control study (mainly well known biases of observational studies).
• 2007: author becomes expert witness in case against drug company, based on his paper.
• 2009, June: journal receives letter from author outlining some changes he wants to make to the paper—corrections, and referring to re-contacting people and re-analysing, reaffirming result of link with vision loss in men with a history of MI who have taken drug A (but only drug A now and not B).
• 2009, August: drug company tells journal that author is expert witness and casts doubt on his letter. They want to release source documents to the journal that have been disclosed to them by the author’s university as part of the court case. The university is resisting because it wants the issues argued in court.
• 2009, October: journal consults COPE, who suggest not publishing the letter until the outcome of the court case is known. COPE clearly discussed it as a conflict of interest issue (letter driven by the fact that the author was the expert witness).
• 2009, August: drug company writes to say author has been excluded as expert witness in the trial because errors in the trial call the study’s reliability into question. Provides transcript of relevant court ruling. This makes it clear that the author became an expert witness in February 2007, after publication of paper but before submission of the letter. He clearly became an expert witness on the basis of the study. Transcript says that author acknowledges inaccuracies—11 of 27 patients who originally reported use of the drug before developing vision loss turned out, from original trial forms, not to have started drug A or B until after diagnosis of vision loss. The ‘history of MI’ in some of the men turned out to be a family history of MI. Author also claimed to have re-contacted patients during the trial but court found no evidence of that. Court concluded that these undermined the credibility of the study. The court also ruled out the letter from the author as being similarly inaccurate.
It is clear that the author as an expert witness was arguing that his study showed causation. It was a small observational study: it could never show causation. We have not yet approached the author for his comments.
So, we would like to take this back to COPE to ensure our proposed course of action below is the correct one. We do not think we have had a case in which a paper has been discredited through a civil court process so we want to make sure that the actions taken are still acceptable.
(a) Ask the author whether in the view of the court opinion he wants to retract the paper?
(b) If author says no, refer to his university, asking it to investigate and consider ordering retraction of the paper.
The advice from the Forum was to retract the article and to quote the reasons for retraction verbatim from the civil court ruling, pending any legal appeal. In the event of a legal appeal by the author, the editor should probably publish an expression of concern in the journal. The editor was advised to contact the author’s institution and inform them of the journal’s proposed course of action and ask them if they had anything further to add regarding the case.
Following COPE's advice, the editor wrote to the author informing him that the journal wished to retract the paper. The retraction notice will be published in the next issue of the journal.
Shortly after publishing a short report, another group involved in similar work accused one of the authors (A) of the short report of fabricating and/or stealing data from their lab. The other group also stated that author A’s conclusions about an image published in the short report were wrong.
We asked to see author A’s original data and talked to his co-authors and the institution where his studies were reportedly carried out. We were satisfied that the data presented in the short report were real and the author’s own, and there was no evidence of data fabrication or theft.
We asked for expert opinion on author A’s interpretation of the image. Three experts thought that the author could not draw the conclusions he had based on the scan he presented in the publication and that reference images produced from the original data were needed to support his conclusions. We went back to author A, told him we were satisfied that there was no evidence of data fabrication or theft, but that we did think he needed to provide more data to support his claims. He did provide some additional images. However, our experts’ view was that the data provided did not verify the author’s claims. He had used images from published articles as reference images, and not reference images from his original data.
In the meantime, the other group submitted a correspondence article explaining how their own studies conflict with author A’s claims. This was sent for review. The reviewer felt that author A’s article should not have been published, but that the other group needed to provide some more experimental detail and data. At this point we approached author A telling him that we did not think the data he provided supported his claims and that he might want to consider retracting the article. Author A responded by sending us several opinions from ‘experts’ he had found arguing that the article should not be retracted. None of these ‘experts’ is an expert in the imaging technique used. He also said he would now be able to provide reference images from his original data, although we have not seen them and do not know, without checking with our experts, whether or not they would be enough.
The short report describes an invasive clinical intervention and makes claims about its efficacy. This is a controversial area of research, and our concern is about leaving something that may not be accurate in the public domain, but we also do not feel that the author has intentionally misled us or the public. We feel at this point that the best course of action is to publish the critic’s correspondence article, along with the authors’ response, and let the public judge for itself. However, given the clinical nature of the short report and the doubts raised about the veracity of author A’s claims, we would like the committee’s opinion on whether the publication of the correspondence piece and the authors’ response is enough, whether we would be justified in publishing an expression of concern about author A’s article or whether there are grounds to retract.
The Forum agreed that the editor had done the right thing by allowing the authors to comment. Exchange of correspondence is ideal in such cases as this will be linked permanently to the original article and so the debate will be in the public domain. The Forum did not think the article should be retracted. Also, the Forum advised against publishing an expression of concern as this indicates that there is something wrong with the data. All agreed that the editor had done all he could except perhaps to write an editorial on peer review and post publication comment.
We did not publish an expression of concern but encouraged the ‘other group’ to submit their revised correspondence. They decided they did not want to, so we have not taken any further action.