An online post-publication literature evaluation service aiming to highlight the best papers in medicine, received an evaluation of a basic science study funded by an NIHM grant. The evaluator declared in his/her competing interests that he/she is the director of a project that included the evaluated study as one of its components. The overall project was funded by an NIHM grant and paid the salary of the study’s first author. The evaluator did not supervise the study or write the paper. As competing interests were declared, the editor decided to publish the evaluation.
The editor presented the case in an editorial meeting, raising the following concerns:
Can we accept this evaluation considering the evaluator is the director of the overall project and may gain from promoting this study’s results?
The meeting made the following decision:
As competing interests were declared, the meeting felt we could go ahead with publishing the evaluation.
Competing interests declaration: I am the director of the grant that paid some of the expenses for the conduct of this study, including the first author’s salary. I did not supervise the work or write the paper, as you can see I am not a co-author. If you look at the paper, it indicates the financial support of a NIMH grant. I am the director of the overall project that included a component directed by the first author that conducted this study.
Would you have taken a different course of action? In particular, do you think it was right to publish the evaluation and is the declaration of interests sufficient in its current form?
Seeing that approximately 1% of evaluators declare any competing interests when probably 90% (again, a rough guess) have interests with regards to the articles they evaluate, would you have any suggestions on how we could improve the situation?
The chair commented that the post-publication literature evaluation services do raise some very interesting and new issues not encountered in paper journals. The majority view of the committee seemed to be that there was a clear and unacceptable conflict of interest and some argued that the evaluation should not have been published. However, the committee advised that it might have been useful to have determined in advance the exact involvement of the author in the study and to publish a more detailed competing interests statement. The editor should consider whether the service’s published advice on competing interests is sufficiently comprehensive.
We had a presubmission enquiry from a group regarding a paper reporting what seemed to be an uncontrolled trial in infertile women who were given soft tissue physical therapy. The authors wanted to know if we would be interested in their paper; if it was a problem that the trial had not been registered (because, they claimed, it was not a trial as no control group was used); and if it was a problem that ethical approval had not been gained (apparently, because the intervention was not a “medical” one).
We replied that they should have registered the trial (and could do so retrospectively) in line with new WHO policies on all interventional studies and that the Helsinki Declaration would require ethical approval for research which examines the effects of an experimental procedure on human health. We asked the authors to tell us which ethics body would provide oversight for their research. The authors thanked us but did not provide the information we asked for.
We were worried that human research had been done without ethical approval and tried to find out more about the research study. (Because this was only a presubmission enquiry, not very much information was included.) Three of the authors were located at a private company in the US carrying out physical therapy and did not seem to be qualified doctors. The affiliation of one author was not clear. Two other authors were qualified doctors. The research seemed to have been carried out at the private company on women referred by themselves or by doctors.
We are not sure who to write to with our concerns. We can write to the medical board(s) and hospitals for the two doctors who are involved but have no idea what body is responsible overall for such a study. We cannot identify an ethics body at the private company.
Who is the company accountable to with respect to the human research it carries out?
As the authors were working for a private company, the advice was to pursue the issue along regulatory authority lines. The editor could write to the medical boards of the authors or the regulatory authorities at the state level. Another avenue could be to contact RESOLVE–The National Infertility Association in the US. The committee questioned if this was in fact a trial, and as there was no patient consent, could there be assault issues?
We wrote back to the authors explaining our concerns and asking for a response. The authors said that they did not think they had violated any legal or ethical requirements (in that they thought IRB approval was only required for entities regulated by the federal government, and not private physical therapy clinics). The authors also claimed their work was not experimental, so it is questionable whether this really was a trial. We plan to write to the authors to say that we cannot consider the study, and that any future research they do in humans should be approved by an appropriate ethics committee. We also plan to write to the state medical boards regarding the involvement of the medical practitioners who were involved in this research.
An online post-publication literature evaluation service aiming to highlight the best articles in medicine has received evaluation of articles published in supplement issues of journals. Given that many supplements are funded by pharmaceutical companies, should we have a different policy on how to handle such evaluations? If so, what suggestions do you have?
The committee felt that it is not necessary to dismiss supplements out of hand as some can be very informative (published abstracts, non-commercial supplements). On the other hand, some members of the committee felt that the conflict of interest combined with the commercial interests of the pharmaceutical companies should deter publication of any evaluations of supplements. The majority view, however, was that a different policy for supplements is not necessary, as long the sponsorship and conflict of interest issues are transparent. It should be made clear if funding is received from pharmaceutical companies.
Author X recently published a paper in Journal Y and has asked for the paper to be retracted. The reason given is that part of the data presented in the paper was published without the permission of a colleague, who is not listed as an author of the paper (and probably does not qualify for full authorship). This colleague is now seeking to publish the data in another journal and it is implied that Author X is also a co-author on the second paper (which has been submitted, not yet accepted). During correspondence with Journal Y, Author X has confirmed that the data presented in the published paper are 'accurate and reproducible in all respects' and the conclusions of the paper are not affected. Author X acknowledges that this is a dispute regarding the use of data without permission, and understands that retraction is a serious matter. However rather than publish a correction, Author X prefers to retract the published paper in order to maintain a good relationship with colleagues. The decision to retract was reached through discussion with the researchers involved, and has not been requested by the authors' institution. As far as Journal Y knows, the institution has not been involved. Can and should Journal X refuse to publish a retraction on these grounds?
As the author has clearly stated that the data are correct, and the only dispute is a small section of the paper that was published without permission, the committee felt that a retraction is not necessary. As the degree of overlap is so small, this is unlikely to constitute duplicate submission. The second paper could cite the first paper and make a note that the data were published previously in error. The journal could publish a correction or an acknowledgement but the committee felt that the editor should hold firm and not agree to a retraction. The committee felt that contacting the author’s institution was not necessary in this instance.
The editor wrote to Author X and explained that COPE committee members had agreed that there were insufficient grounds to retract the paper published by Journal Y. Instead the editor recommended that Journal Y publish a correction to the paper acknowledging the input of the colleague who generated the data in question. The editor also noted that it should be made very clear to the editors of the other journal that the data had been previously published in Journal Y. Author X passed this recommendation onto his colleagues who then agreed to publication of a correction rather than retraction of the paper. Author X expressed appreciation to us and to COPE for helping to resolve this matter.
This is regarding a case of suspected plagiarism in our journal. I as editor have received a manuscript which was published by me in our January 2006 issue and on subsequent follow up after availability of plagiarism detection software the manuscript - a review article - seems to have a lot of similarities to another article written in a website and though the language is not the same -the flow of the article and the subheadings and the text is too similar.It was pointed out to me by my associate editor.There have been no complains yet but does that mean one should not investigate?Is the editor entitled to conduct investigations without complaints.Can plagiarism detection software be applied retrospectively?What action can be taken if only ideas are copied in the same sequence though the article is not copied verbatim.The photographs seem to be same but captions different.Should this be investigated further?How?
The committee agreed that plagiarism detection software can be applied retrospectively. Even if the editor has not received a complaint, plagiarism is serious misconduct and should be investigated. The fact that the illustrations were the same could raise issues of copyright. The advice was to contact the author in the first instance, requesting an explanation. The letter should set out the case but not make any allegations. The author should be given a time limit in which to respond. If no reply or an unsatisfactory reply is received, the editor should inform the author that he will contact the author’s registration body. If the editor decides to contact the author’s registration body, he should include the two papers, express his concerns and request an investigation. If plagiarism is proved, the editor can then decide to retract the paper. Other advice was to inform the website of the situation to determine if there has been a breach of copyright.
We had a paper submitted reporting results of a randomized trial. The trial seemed to look at immune responses in lung fluid in participants receiving either a particular vaccine or placebo. We got a copy of the trial protocol before going to peer review as per our normal editorial policy, and made sure the trial was registered.
One reviewer pointed out major discrepancies (principally in sample size and outcome measures) between the trial report, and the protocol document and registration record. We asked the authors to revise and to explain why these discrepancies had happenned. The authors explained that that the protocol and registry record originally sent were actually for a totally different study, and they had now separately registered the trial reported here. They also sent a new protocol document apparently now corresponding to the study in question.
This revised paper then went to re-review and the reviewers were happy. However in house journal staff were still worried about differences between the new protocol and the study reported in the paper. The new protocol did not seem to describe the conduct of a trial but rather a case-control study. There were also differences in the number and timing of invasive procedures being used to assess outcomes in the study, and there seemed to be more of these in the study report than in the protocol.
We went back to the authors to say we were very concerned about this and would need their explanation. If they weren't able to provide an explanation then we would alert their ethics committee.
The authors wrote back to us, cc'ing the heads of their two research ethics committees, to say that indeed, the manuscript did not match the two different protocols they sent us. They explained that there was a fault in the manuscript and not in the work carried out. They explained that the paper they sent us did not describe a single study but rather parts of 4 different approved studies taking place over the same time frame and being carried out on overlapping study populations. They then detailed aspects of these studies and explained that the different interventions, assessment of outcomes, etc, that were reported in the paper indeed corresponded to sections of approved protocols. (Although, no single protocol explained all of the aspects reported in the paper).
At this point we are very concerned about the following things:
Individual participants being recruited into many different ongoing studies - were the ethics committees aware of this and is it wise?
Selective reporting of findings. Presumably the main outcomes for the protocol describing a trial (ie the one involving randomization to vaccine or placebo) have gone unreported. Why? We are also very worried about validity of the data and analyses (even to the point of suspecting fabrication, of a sort), because of this level of selectivity.
Misrepresentation in the original manuscript. Our assumption when we see the report of a trial is that, unless it is presented as a secondary, follow up, or other type of ancillary or nested analysis, then the report describes all of the main aspects outlined in the approved protocol. This wasn't the case here, but how serious is this? Is it a form of scientific misconduct and if so who should we report it to? (The ethics committee may not care - are there any "rules" that a trial, once approved, has to be published in the form it's approved?)
At this point we are considering rejecting the paper essentially on the grounds of protocol deviations, and sending all relevant documents and correspondence to the ethics committees (who are already aware of the issues raised).
The committee warned that the ethics committees could be part of the problem, and so seeking help from them (who are already aware of the issues raised) may not be very useful. The editor provided the update that the paper has now been rejected and that the author has made a formal complaint about the editor on the grounds that the paper was mishandled. The committee were unanimous in their support for the editor who they said should remain firm in the face of the authors’ allegations. Further advice was to contact the authors’ institutions and inform them of the issues. The committee cautioned that this case highlights the need for trial registration for all studies.
The paper was rejected. The editor wrote to the chairs of both ethics committees enclosing a copy of the paper and protocol documents. The Director of Publishing dealt with the author’s complaint about the editor, and wrote back to the author to uphold the editor’s handling of the paper. We did not hear back from one of the chairs of the ethics committees but the editor did speak to the other chair, who felt that we had not understood the realities of conducting clinical research, in which protocols may change. We decided not to go to the authors’ institution to pursue this case further.
After peer-review, a general medical journal published a household survey of violence following a coup against the country’s elected President. The survey revealed high levels of violence and human rights abuses, only a small minority of which were attributed to supporters of the deposed regime. The manuscript stated that none of the interviewers had political affiliations and the authors declared that they had no conflict of interest.
Within days of publication the Editor was contacted by an expatriate from the country and by a local aid worker who expressed incredulity over the fact that the findings attributed so little of the violence to supporters of the deposed President’s political party, It was also pointed out that one of the authors was acquainted with the deposed President and had previously published pieces under a different name which were supportive of him. Some of these pieces were cited in the manuscript.
The author admitted that she had done this and the co-author, her thesis supervisor, stated that he was aware of these facts and did not consider them a conflict of interest.
Not satisfied by the responses from the authors, the Editor asked the Dean of the authors’ institution to undertake an internal investigation to verify that the data had been coded accurately. Results are expected by the end of 2006.
This interesting case prompted much discussion. The committee felt that the conflict of interest should have been identified in the peer-review process and were surprised by the reviewers’ responses and their failure to pick up on the political bias. The committee agreed that the editor has a duty to his readers to inform them that an investigation is ongoing. He should tell his readers that there have been allegations made about the paper but that it is not possible to establish the truth as yet. Hence the advice was to issue a statement of concern in the journal or possibly write an editorial highlighting all sides of the issue.
Following discussion of the case, a statement was published in the journal, a summary of which is given below.
In response to credible allegations that one author’s former activities might constitute an undisclosed conflict of interest, the journal began an inquiry. The authors’ institution was asked to investigate the matter, and the issue was referred to the Committee on Publication Ethics (COPE).
The institution audited 100 questionnaires selected by computerised randomisation. Outcome details on the original handwritten records corresponded with the project’s computerised database. The overall distribution of rapes and murders were re-analysed according to alleged perpetrators, and the results agreed with the published findings. Outcomes were then compared by political affiliation of the interviewer and for the author’s own data (as an interviewer). Again, there was no evidence of systematic bias. On the basis of this investigation, the journal has confidence in the authors’ findings as published.
COPE recommended that readers should be made aware that the author had published as a reporter under another name, and that failure to disclose a separate name, under which relevant material had been published and cited in her paper, constitutes an undeclared conflict of interest. The journal’s position on transparent disclosure of potential conflicts of interest is in accordance with guidelines established by the International Committee of Medical Journal Editors. The journal has made this position prominently available to readers and to authors, and stated clearly that incomplete disclosures will be amended in a published statement in the Department of Error section, which will also be linked electronically to the publication in electronic databases. Such a correction for this study appears in today’s journal.
To realise their full potential to benefit populations, research findings must influence practice. Intelligent debate is part of that process. The journal encourages genuine debate, and will always consider seriously allegations of scientific misconduct. It is unfortunate, however, that in this case much of the debate was aimed at exploiting historical divisions in the country in question. That process has obscured the message of the authors’research and detracted from the real issue—the welfare of civilians in that country—to whom attention should now turn.
An article was submitted simultaneously to our journal and another journal (who is a member of COPE) on the same date. Both journals received letters saying that the article had not been submitted to another journal. When they received a favourable response from the other journal, and the article was published, we were informed by the authors that they wished to withdraw the paper from our journal. The authors claim that this was a result of a misunderstanding and poor communication between the authors.
I believe this is a poor excuse and I am not sure that I believe the authors. What do the committee think would be a proper reaction?
The advice from committee was to write to the author’s institution, reporting the behaviour of the authors. The committee agreed with the editor that it is most likely that the authors mislead the editors on this occasion as they must have signed two letters on the same day stating that the article had not been submitted to another journal.
The editor wrote to the authors but received a very unsatisfactory reply. The editor reported back to the editorial board. The editor has decided not to accept any submissions from these authors for the next two years.
An article by a Far Eastern group was published in our journal in November 2005. We were later alerted by an interested reader that the same article, slightly changed, was published in an American journal. I contacted the American journal and the article will now be officially retracted from that journal. Part of the explanation could be poor communication between the authors, but I am not sure this is the whole truth. Two of the authors accept guilt but are now asking that the others not be “punished”.
I would appreciate the committee’s advice on this matter as I have no experience regarding how to react to such situations. What is “the accepted way to react/punish”?
The committee agreed with the editor that it is unlikely that this was “an honest mistake” or misunderstanding on the part of the authors. It is most likely that the two papers were submitted for publication at the same time. The advice was to contact the author’s head of department informing him of the situation and asking him to consider investigating the case. Other advice offered was to contact the American journal and ask them if the authors had stated in a letter that the paper had not been published previously.
The editor received a very profuse apology from the authors who stated that the misunderstanding arose because of lack of communication between the authors. Those authors who thought that the paper had been rejected started a process with the American journal (where the paper was published 6 months later). The editor contacted the chief editor of the American journal and informed him of the situation. The article was officially retracted from the American journal. The editor has decided not to pursue the matter any further.
A Middle Eastern author submitted four papers on different subjects at around the same time (two single author, two with other authors). During in-house assessment, it was noted that two of the papers were very similar to previously published papers. Fuller inspection of the complete papers indicated unequivocally that plagiarism had taken place—in one of the papers even the figures have been copied from the published paper. Software was not used. The key was the fact that the plagiarised papers were quite recent and so appeared prominently on Pubmed.
We contacted the author asking him to confirm that the submitted papers do indeed represent original research but received no reply. The papers are now on hold as we contact the head of the institution in question.
The editor of the journal confirmed at the committee meeting that no reply has been received from the author and that the paper is no longer on hold as the journal has decided not to publish. The editor is pursuing the head of the institution in question. The committee commented that the correct course is being pursued, in accordance with COPE’s flowchart on “Suspected plagiarism in a submitted manuscript”.
The editor wrote to the prospective Middle Eastern author (who submitted two papers which had been copied from papers published previously by other authors) and to the head of his institution, without reply.
One might have hoped that the individual in question would have realised that detection was inevitable, but it appears not. After the author had been contacted by the editor by email, one of the plagiarised papers was published in a peer reviewed pathology journal (although not one indexed in Pubmed).
We propose to contact the editors of the journal in question—there is a European editor based in the UK—alerting them to the situation and asking them to investigate.
Should we also contact the plagiarisees and/or the journal their paper was published in?
Advice on follow up:
The Forum agreed with the editor’s course of action to contact the editors of the journal. The Forum also supported contacting the author, as well as the wronged authors whose work was plagiarised and the wronged journal where their paper was published.
Update (December 2007) We contacted the authors of the published manuscript that had been plagiarised, and they agreed that there had been flagrant misbehaviour. The author in question is on the editorial board of the journal in which the bona fide paper was published.
We then contacted the editor and European editor of the pathology journal (the former apparently a Brigadier by day), who responded with shock and regret. The offending (plagiarised) paper has been removed from their website, and a note is going to be published in a forthcoming printed copy of the journal to explain the situation. We have drawn the COPE website to the editors’ attention for future reference.
Update (February 2008) The editor considers the case now closed.