Data falsification

An institutional review recommended retraction of certain works by a highly prolific and influential author who has since died. The institutional review focused on a relatively small portion of this author’s work. The institution recommended retraction based on deeming the articles unsafe and identifying several concerns, including that the articles' conclusions were implausible.

As a publisher, we are moving forward with reviewing potential retraction of the articles identified by the institutional report. We are questioning whether we should also review the other articles written by the author in the journals' backfile, based on the following:

1. The institutional report cited serious systemic concerns with the research and findings.

2. The author was highly influential.

3. Many of the articles were published in the 1970s/1980s or earlier.

4. Other areas of the author's work/findings seem contrary to current scientific standards (and potentially harmful).

Question(s) for the COPE Forum

• When responding to an institutional report recommending retraction of certain articles, should editors review the other works of an author as part of their response (and depending on the reasons the retraction was recommended and the potential relevance to the author's other articles, issuing an editor's note or expression of concern to reference the concerns identified in the report findings for the separate retractions).
• With respect to articles in the journal's historic backfile that reference findings that have since been overturned by later works and do not meet current scientific standards (and are potentially harmful or are supportive of a practice that has since been prohibited), is it appropriate for journal editors to initiate their own review of these articles? Should these articles be retracted, or would these cases be more appropriately handled with a “statement of concern” alerting readers to the concerns with the article's findings
• Is retraction an appropriate action so long (decades) after publication?                      

Editorial office staff at journal A noticed possible image manipulation in two figures of a new paper submitted by author X. These suspected manipulations involved images of gels which appeared to contain multiple duplicated bands. This prompted editorial staff to look at the submission history of author X to journal A in more detail.

It was found that author X had previously submitted to journal A numerous times. All previous submissions had been rejected for reasons unrelated to the concerns raised here but one paper had been accepted for publication. Unfortunately, this author X paper which journal A had published appeared to contain possible band duplications in two gel images, as did an earlier submission which had been rejected at the start of 2015. As at least three papers received by journal A from author X has suspected image problems, authors X’s recent publication history was examined.

Similar possible gel issues along with a suspected image duplication relating to a photo of bacterial colonies were identified in three papers published in three different journals (journals B, C and D). Two members of editorial staff along with the editor-in-chief of journal A have considered all of the suspected issues and feel confident they are legitimate. As it currently stands, journal A has rejected the most recent submission from author X on the grounds of possible gel issues identified. However, the suspected issues identified in the four published papers in journals A, B, C and D were not mentioned in the rejection letter to allow time for an appropriate course of action to be decided.

As the paper was only recently (12 August) rejected by journal A, it has yet to hear back from author X, if indeed it does at all.

Journal A feels that it is important that journals B, C and D are made aware of the issues in the papers they have published. However, they also feel that it is important that they are made aware of all of the papers involved so they can appreciate the full picture as this may determine how they choose to handle the issues in their own respective journals.

Question(s) for the COPE Forum
• Would COPE advise that journal A contacts journals B, C and D at this stage? If so, what sort of information could legitimately be provided to the other journals? Should Journal A provide journals B, C and D with copies of all of the papers involved, including the unpublished papers submitted to journal A which were rejected without review? Would this breech confidentiality or would the importance for full enclosure trump confidentiality concerns in this situation? As most of the suspected issues only become apparent when the brightness/contrast levels of images is adjusted, journal A has put together PowerPoint files for each respective paper involved to highlight the possible issues identified. Would COPE advise providing copies of these PowerPoint files to journals B, C and D so they are under no doubt about the possible issues identified or could this be considered a defamatory action in the (what we feel unlikely) event journal A is mistaken over these issues?
• What type of action would COPE recommend the journals take should all agree with the issues identified? Would retraction be called for, considering the numbers of papers involved? Should author X’s institution be contacted? Journal A feels it is important that these issues are addressed but also feels somewhat uncomfortable with the idea of having a hand in potentially destroying someone’s career and livelihood.
• Journal A has not looked any further beyond the papers mentioned above as every published author X paper examined appeared to have potential issues so a line had to be drawn somewhere. However, journal A suspects that there may be other papers from author X in the literature with similar possible issues. Who is responsible for checking the publication history of author X for issues? Would it be author X’s institution should you recommend this be referred to them?
 

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?

In June 2014 we received a manuscript by four authors from a well known research institution. They described a randomized trial comparing a variation in a procedure with standard care. In total, 200 patients were randomized, 100 to each arm. As measured by an interview, patients undergoing the new procedure were statistically significantly more content than those in the control arm. This manuscript was submitted 116 days after the same group of authors had sent us a first manuscript on the same topic.

The first manuscript, however, described an observational study: 50 patients had chosen the new procedure, 50 underwent conventional treatment. The patients rated the new procedure higher (statistically significantly). In their discussion, the authors mentioned as a limitation the non-randomized status of their study and called for a randomized comparison. At the time we rejected the manuscript because we were not convinced by the non-randomized design of the study. The senior author appealed our decision saying that it was very difficult and almost unethical to carry out a randomized trial. We did not change the decision but I granted the author that we would evaluate and possibly review a manuscript on a randomized study.

In the cover letter of the second manuscript, dated June 2014, the authors referred to this discussion and stated that 100 patients had been randomized to each group. [As an aside, in an online source detailing procedures carried out in the department of the authors, the procedure in question is said to have been performed more than 1200 times a year. As a consequence, it is conceivable that the authors have randomized 100 patients to each study arm during a period of 3–4 months. In his appeal to the rejection of the first manuscript, the senior author mentioned that the ethics committee had already expressed approval. And yet, common experience with randomized trials indicates that the present study would be an extremely fast trial regarding screening, consent, inclusion, examination (4 days after the procedure), and analysis.]

Here is the problem: the results are identical in manuscripts 1 and 2. In numerical form the results are only presented in tables (not in the main text and not in the abstract). In all three tables, the values are identical in both manuscripts. All three tables were submitted as one file, leaving open the possibility that the author mixed up files. The figure (a horizontal, stacked bar chart) is slightly different but the numbers indicating the results, however, are identical. This figure was submitted as a different file.

The main text of the second manuscript is identical to the first one except for minor updates in relation  to the numbers of subjects and study design. All four photographs illustrating the procedure in both manuscripts are identical. The reference list is identical.

I can think of only two ways to make sense of this submission: sloppiness or fraud. Under the sloppiness  assumption, the authors would have submitted a text referring to their randomised control trial and tables, referring to an earlier observational study. This is conceivable mostly because it is hard to imagine that authors believe they can get away with submitting the same data in two manuscript describing two completely different trials and separated by only 4 months. On the other hand, the tables and figures differ in layout and several details from those submitted with manuscript 1. If sloppiness is not the reason, it must be fraud, and we can only reject the paper.

I feel we should be frank with the authors about our decision to reject the paper. Confronted with this decision, however, the authors have no incentive to cooperate with us and to send us, for example, original data. Rather, they may blame the mess to an unfortunate confusion.

Question(s) for the COPE Forum
(1) We have decided to reject the paper but how does the Forum think we should now proceed?

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

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

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

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

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

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

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

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?

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

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

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

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

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