The journal is operated by institute A, and the editor is an employee of institute A. A manuscript was submitted late in 2014 by authors from institute B, a similar type of organisation in the same country. The manuscript was reviewed by two referees who both recommended publication following minor revision. One of the reviewers noted that the abstract contained a vague statement related to the effectiveness of a treatment for a major type of export from the country but there was no further detail in the main text. In addition, the issue of worker safety was raised in the introduction but not discussed elsewhere. There was also a lack of context for the work and a lack of relevant conclusions. The authors were asked to add more detail on each of these points.
In May 2015, the authors submitted a revised version of their manuscript, which contained more relevant information and references to support their statements. The editor and associate editor considered that the authors had dealt with the issues raised by the referees and accepted the paper. The paper was published on 4 July 2015.
A senior manager at institute B rang the editor a few days after publication. The manger stated that the original manuscript had been approved for submission by institute B but the revised manuscript had not, and asked the editor to remove the paper from the journal’s website immediately. The editor said that this was not possible and further explained that if institute B wanted the paper retracted then they would need to provide a written justification.
Within an hour, the editor received three emails from the manager at institute B. The first one said that the paper “contains errors and speculation which were not able to be addressed at the time of finalising the text, as the paper was not re-submitted to the institute B editorial process following review by the journal” and that institute B believed “the paper is not in the interests of furthering an accurate and complete scientific record of the research in this field and therefore respectfully ask that it is retracted”.
The second email said that the manager at institute B had “since been in contact with the industry group who funded the project and they believe the inaccuracies are ‘significant’. As such, I’d like to emphasis the urgency in our request. I understand that in general journal referees remain anonymous unless they choose to identify themselves. In this instance I’ve been asked if we are able to learn the identity of the referees. Would you please comment on this so that I may respond appropriately?”
The third email said “Since I was in touch with you earlier today, the funding agency has had feedback from the relevant government department who have offered their support with responding to ensure the paper is corrected. I think this indicates the concern that these parties have in ensuring the information is accurate. The errors of fact and subsequent speculation to consequences related to worker safety and fumigation efficacy are problematic.”
The editor gave this matter urgent attention by reviewing the paper and checking the journal’s ethical guidelines (which are those of COPE). They concluded that a retraction was not warranted because the majority of this paper had not changed post revision so the potentially misleading revisions amounted to just a small portion of an otherwise reliable publication. The editor also concluded that, in accordance with COPE guidelines, the authors should submit an erratum detailing the specific passages of text that were incorrect and provide factually correct rewording. The editor sent these conclusions in an email to the manager at institute B the same day and waited for an erratum to be submitted promptly given the apparent seriousness of the situation. The editor did not reveal the names of the referees as the journal operates a closed review process. The editor also alerted the journal’s overseas publisher to this issue in order to fast track the erratum.
Ten days later, no erratum had been submitted to the journal but the editor was copied into an email from the funding agency to the manager at institute B. The agency thanked the manager for drafting an erratum but advised them that the funding agency and government department considered the risk associated with publishing an erratum to be too great so one should not be published. The funding agency also asked that both institutes A and B “manage their processes to ensure that any similar event does not occur in future”.
The manager at institute B forwarded that same email to the editor with a note saying that an erratum would not be submitted. The editor replied expressing surprise that an erratum had been drafted (but not submitted) and that it was not up to the funding agency/government department to decide whether or not an erratum should be published. The editor explained that the authors had an ethical obligation to correct the scientific record if errors existed. However, if there were no factual errors but simply statements that some people happened to disagree with, then no erratum was necessary. The Editor asked the manager at institute B to confirm which of these situations was the correct one and the manager replied stating that there were “no errors in the paper”.
Since then, the editor has been advised by colleagues that the funding agency has been alleging that publication of this paper could harm a key export industry for the country and cause substantial economic losses, and that institute A was at fault by allowing its journal to publish such sensitive work. These allegations are being strongly refuted by institute A. At no point have the authors of the paper communicated with the Editor.
The Editor has submitted this case to highlight concerns that: • key stakeholders in a published work (but not the actual authors) have attempted to suppress legitimate scientific results because of possible economic and political damage to an export industry; • this is a serious breach of scientific ethics; • unfounded allegations have been levelled at the journal’s owner for allowing the paper to be published.
Question(s) for the COPE Forum
What further steps or alternative actions does COPE recommend be taken?
This is essentially a conflict of interest issue, not with the authors, but with the employers/funders, emphasising the ubiquitous nature of conflicts of interest. The editor proposed that having clear guidelines and examples for similar situations from COPE would be helpful to resist pressure from funders or employers.
The Forum congratulated the editor for standing her ground, and agreed that the editor had done the right thing here in not bowing to pressure from the funders. As a way of avoiding a similar situation in the future, a suggestion was to ask authors to submit a statement on “the role of the funding source” as a way of outlining the role of the funder and clarifying issues such as: did the authors have control of the data at all times, and did the funder have a role in the analysis or submission of the paper? This would also help define the roles of the authors and funders. The authors are the researchers and should be in control of the data. There should not be any pressure from the funding source to try to manipulate the analysis or interpretation of the results or to influence the decision on where to submit the paper for publication. Both parties need to understand their roles.
Some journals ask each author to complete a separate conflict of interest form, and this may be something the editor might consider for the future.
A suggestion from the Forum was to write an editorial, highlighting the issue. This is an important issue and also raises the fact that government or other funders can be as conflicted as private companies, and this is especially true in small countries and for journals that are national journals.
Author Written and approved by COPE Council June 2008 Version 1 2008 How to cite this COPE Council. Guidelines for the Board of Directors of Learned Society Journals. Version 1. October 2008 https://doi.org/10.24318/cope.2019.1.5
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Our journal was contacted by a representative of a company following acceptance of a manuscript that was based on a clinical study sponsored by that company. Upon acceptance, the senior author had forwarded a copy of the manuscript to the company, who had identified some discrepancies between the data presented in the article and an initial report that had been presented to them while the study was still underway. They stated that these discrepancies had been brought to the authors' attention but that a satisfactory resolution had not yet been reached and that they had requested a full independent audit.
The authors, who were copied on this correspondence, were asked by the journal to clarify the discrepancies. In a letter to the company and the journal, the authors responded to each of the concerns that had been raised. They stated that the discrepancies resulted to some degree from the use of a different analytic technique in the submitted article, citing the CONSORT statement as evidence that this technique has become the favoured form of analysis since the initial report, which was presented almost 15 years ago. They also acknowledged that one of the numbers presented in the initial report was inaccurate and that they had redone their analysis to ensure accuracy in their results. A revised manuscript was included with this letter.
The company responded that they were not satisfied with the authors' responses and repeated their request for an independent audit. The authors responded that they did not have the resources for an independent audit but would conduct an extensive internal one. The associate editor who had accepted the manuscript and a representative of the editorial board were asked to assess the company's claims and the authors' responses and they felt that the authors had satisfactorily answered the questions that had been raised.
The company contacted the ethics committee of the authors' institution and reported their concerns. The institution's CEO reported that the ethics committee, as well as the institution's board, had investigated the situation and found that while errors had occurred, they did not constitute research misconduct and that they did not see this as an ethics issue. They said that the decision regarding publication should be left to the discretion of the journal's editors.
Our publisher's legal team was consulted, and they felt that if the journal editors were satisfied with the authors' responses and the relevant changes to the manuscript, then they did not see any reason not to publish the paper. They also advised that our society's board of directors should review the situation and recommended that the case be submitted to COPE, a recommendation endorsed by the society's board.
The company continues to maintain that an independent audit is needed. The authors contend that the company is seeking to delay or stop publication of the article, perhaps because of its implications for a line of products produced by the company.
The Forum asked whether the company had any contract with the authors requiring them to have company approval before publication. The editor told the Forum that the only contract that was found was a 15 year old letter about the authors promising to produce results.
As the institutions found no evidence of misconduct, and the editor is satisfied with the paper, most agreed that the paper should be published but that the editor should perhaps consult the journal’s legal team and the society's board. All agreed the editor has done all the right things and ultimately it is his decision whether or not to publish. An editor does have a duty to publish good research.
The Forum thought it might be helpful to consider whether the editor is reacting differently because a commercial company is involved. Also, the editor should be prepared for any negative publicity or even legal ramifications if he publishes the paper. How will the editor handle letters from the company criticising the paper? Will he publish them?
Another suggestion was for the editor to write a commentary or editorial outlining the issues involved in this case.
Following review of the Forum discussion, the society's board of directors agreed to proceed with publication of the article. Rather than drafting a full editorial to explain the controversy, a footnote was added to the manuscript to explain the unusual delay between acceptance of the manuscript and publication. The authors were notified of this, and agreed to the proposed language for the footnote. The company that had raised the concerns was also notified that publication would proceed and provided with the relevant deadlines should they wish to submit an official correspondence. The correspondence arrived within days and it and a response from the authors were both published in the issue that followed the one with the article itself. Because the letters are now linked to the article and its entry in most citation databases, the company's concerns and the authors' response are now entered into the public record. The society and editors are grateful to the Forum for its advice; being able to say that an independent body had reviewed the situation was beneficial.
Following publication of an article, the editors noticed that the paper reported results of a clinical trial, but no details of trial registration were included in the article. (The journal does have careful checks on trial registration by staff at submission but this paper was not well written and it took careful reading to work out that it did in fact report on a clinical trial).
We contacted the authors to request details on trial registration and the study protocol, which are journal requirements for clinical trials. The senior author (co-chair A of his institution) eventually acknowledged that the trial had not been registered and they provided a document for the study protocol which we considered unsatisfactory. The authors at that stage requested ‘withdrawal’ of the article.
We replied to the authors to indicate we had the intention of issuing a notice of concern based on lack of trial registration. Given the new issue about the lack of a satisfactory protocol for the study reported, we then requested a copy of the letter of approval issued by the ethics committee/institutional review board cited in the article. Around this time, we were spontaneously contacted by co-chair B of the authors’ institution (who is not an author on the paper) expressing serious concerns over the work reported given that:
(1) they considered the description of the work as potentially misleading given it fulfilled the criteria for a clinical trial; and (2) the ethics committee/institutional review board cited in the article does not exist at the authors’ institution.
Co-chair B indicated they would like to remain anonymous but would be willing to publicly outline their concerns as part of an internal investigation if a formal request for an enquiry was sent to the institution. We did not hear back from the authors for some time after our request for a copy of the ethics committee approval, so we posted a comment on the article to make the readers aware about the fact that the article did not adhere to the journal’s requirements for clinical trials and replied to the authors to explain the implications of a retraction—versus a ‘withdrawal’—and also reiterate the request for the letter of approval issued by the ethics committee.
In a further development, the authors finally then contacted us to say that the study was not in fact done at their institution but in a separate part of the country, that they did have approval from an ethics committee other than the one stated in the paper and provided a copy of that ethical approval in a non-English language. They provided no explanation for the discrepancies in study setting and ethical approval. It is not clear to us who recruited the participants as no authors seem to be based at the institution now claimed as providing ethical approval.
We have been unable to independently verify the authenticity of the claimed ethical approval and have concerns about the discrepancies in the various accounts of what took place. We think it is important to retract the paper and propose to do that, highlighting the lack of trial registration, lack of an appropriate protocol and that the ethics committee named in the article did not seem to give approval.
Is it adequate to proceed to retract the article on the basis of the concerns raised and the lack of an adequate response from the authors, given that we have been unable to establish whether the trial did or did not receive ethical approval? We also propose to submit a formal request for investigation to co-chair B of the institution (who currently wishes to be an anonymous complainant) and update the retraction later should we receive further clarification from them.
The Forum agreed that the editor certainly has enough grounds to issue an expression of concern. However, most agreed with the suggestion that the editor should submit a formal request for an investigation to be carried out by the institution. If the investigation provides evidence of misconduct, then the editor should retract the paper.
However, some of the Forum argued that there are already grounds for retraction and that retraction is justified on the basis of the lack of appropriate protocol, lack of trial registration and possible lack of ethics committee approval. Hence, although ideally a formal investigation should be conducted and the editor should wait for the outcome, if the institution does not respond or if the response is unsatisfactory, the editor should retract the paper anyway.
The editor wrote to the co-chair of the institution to ask for a formal investigation, and received an acknowledgement to say this would be done. The editor has not yet received any further details from them but is following up to find out more.
The journal plans to issue an expression of concern and have had to set up the ability to do this as a new type of article in their production systems.
Follow up (December 2011):
We heard from the institution's investigation committee, which determined that the trial had not been conducted by the authors of the paper published in our journal. Rather, the authors of our paper had received samples from the investigators who had conducted the trial, and were reporting results of analyses done on those samples. The individual named in the investigation committee report as the principal investigator for the trial was not named in the manuscript published in our journal, either as an author or as an acknowledged person. The investigation committee reported that the oversight and conduct of the trial had been appropriate, but that ethics approval had in fact been given by a different ethics committee from the one named in the manuscript published.
The investigation committee reported that the trial, funded by a commercial company, had in fact been carried out at the company, recruiting as participants employees of the company. We were not aware of this fact when we published the paper and the setting and participant recruitment for the trial were not well described in the manuscript. The investigation committee reported that they would not have expected this study to have been registered as a trial, bearing in mind their country's local laws. This was because the intervention used in the trial was an approved medicinal product —essentially it was a postmarketing study. In that country, such studies do not need to be registered.
The journal editors have decided to proceed with an expression of concern, noting that the ethics committee named in the paper as giving approval in fact did not, and that a different ethics committee gave approval. We plan to describe the setting for recruitment of participants and state that the company employees were participants. We would like to state that the trial was not registered and should have been, under our journal's criteria and ICMJE criteria, even though it may not have been a legal requirement in that country.
We received a paper describing the results of an analysis of pathogen gene sequences from patients who had been given an investigational drug as treatment for their infection. The study had been done in Europe. One reviewer said that the paper did not explain whether the patients had been treated in the context of a trial or not and that no information about study sponsorship, ethical approval or patient consent had been included.
The reviewer was concerned that an attempt was being made to publish data without the approval of the trial sponsors. The editors rejected the paper but recommended that the authors submit it to a sister journal at the same publishing company, but that they would need to address all of the points raised. The paper was then submitted separately to the sister journal but without any response to the reviewer’s points. The authors eventually explained that the patients in this study had been enrolled in an expanded access program for the investigational drug, which was underwritten by governmental sources. This was not regarded as a trial, and the authors explained that gene sequencing was carried out as part of routine clinical care, following national treatment guidelines.
The editors felt that there were insufficient grounds for them to follow-up further, and decided to withdraw the paper from consideration at the sister journal, recommending that the authors describe the context for the study more fully in their paper when they prepare it for publication elsewhere.
Should we have done more; is it reasonable that ethical approval and informed consent would not be needed for this study?
The Forum commented that this is probably an example of different rules for ethical approval in different countries. This would seem to be the issue here. The Forum agreed that no further action was required and that the matter should not be pursued.
The journal followed the COPE Forum’s advice and did not take further action.
An editorial board member of a journal submitted an unsolicited review article on a drug. The editor said the journal would consider the article, but suspected that the article had been commissioned or even written by a drugs company. S/he stipulated that the author must provide a financial disclosure statement before the article could be accepted. The journal published the review article, which had been refereed by two independent reviewers. The author disclosed in his competing interests that he had been a paid consultant for the company that markets the drug. Several months after publication, an agent for the drug company ordered reprints of the article. The agent requested the wording: “This literature review was supported by [X]” be included on the cover sheet of each reprint. The agent was advised that this statement could not be added because the author had not disclosed it. The agent insisted, so the journal contacted the author. The author asked: “Does the final article have these words or something that states the article was in part supported by [X]?” A copy of the agent’s wording and the competing interest statement from the published article were sent to the author, who replied that he was fine with it as long as the publisher was. The author was then asked to explain the extent of the drug company’s involvement in writing the review article. The author replied that the competing interest statement in the article was accurate; the review had been written independently of any pharmaceutical company, and that the requested statement from the agent was inappropriate. The author was contacted again to point out the contradiction in his two replies. At the same time the agent was asked to question the drug company as to whether it had paid the author to write the review, and to confirm the extent to which the drug company had been involved in preparation of the manuscript. The agent did not reply; neither did the drug company. Eventually, the agent cancelled the reprint order. The author finally replied to confirm that he had been confused by the original request, thinking that clarification of whether he was a paid consultant to the drug company was required. He said that when it became apparent in a follow-up email that the drug company wanted the extra statement added, he realised it was inappropriate. The author assured the editors that the drug company would write a letter of explanation soon. The letter has yet to arrive.
- This case raises serious concerns. The connection was not made clear and this is a full conflict of interest. - The paper should be retracted. - The author should be asked explicitly if s/he had been paid by drug companies to write this review.
A large study—parts of which have been published in several major journals— purported to show that a drug may reduce side effect X without acting through an important intermediate process Y. This suggests that the drug may have important advantages over similar drugs in its class, and indeed it had been marketed as such. But a critic thinks that the drug may indeed act through the intermediate process Y but that this had been disguised by the way in which the drug had been taken. This was not described in the major papers, but has now been reviewed in a comparatively minor study. The editor had tentatively agreed with the critic to consider publishing a paper that discussed the mechanism, but it had been difficult to find out information on the trial protocol. - Could the authors have deliberately misled readers by not describing the drug route? - Does this amount to deception?
- It is impossible to know from the initial information whether the authors deliberately attempted to deceive by disguising the manner in which the drug was taken. - Why had it been difficult to find out information on the trial protocol? Had the pharmaceutical company exerted pressure for this information not to be released? - The editor should publish something to the effect that the apparent benefit may arise from the manner in which the drug is taken.
Somebody—possibly a representative of a drug company or a PR acting for the company—rang an editor on behalf of study authors to say that she would guarantee to buy 1000 reprints if the journal would continue to consider for publication a study that conflicted with a policy that the journal had just introduced. “And”, she said, “I will buy you a dinner at any restaurant you choose.” The paper was rejected, but should further action be taken?
_ Generally drug companies have policies against PR companies approaching journals and if the drug company was identifiable then the editor could contact the company concerned to complain. _ The lead author of the study should be informed about the actions of individuals representing the product being discussed in the paper. _ The drug company might also want to know what the PR is doing on its behalf. One of the members relayed how in a similar circumstance he had complained to the drug company which had withdrawn its contract with the offending PR company.
The editor admitted that he could not remember the name of the person involved and was unable to trace the article, but he promised to mention the incident in the journal. He fulfilled his promise.
A systematic review on the effectiveness of a comparatively new group of drugs was submitted. The review had originally been for an independent body, so the submission was an abridged version. A reviewer pointed out that the review made no reference to a Cochrane review and the trials it cited, which had been published some four months before submission of the paper to the journal. The reviewer suggested that this was more than incompetence: he knew the authors were aware of the existence of the Cochrane review. He also questioned the role of the study’s advisory group which had supposedly “provided peer review and advice regarding the protocol, analysis, and interpretation.” He thought that the advisory group had not been involved throughout the project and had not peer reviewed the submitted manuscript. Another member of the advisory group seemed to confirm these suspicions. What should be done now?
_ The Cochrane Database of Systematic Reviews is designed to be used by anyone. The paper was an incomplete systematic review so it should be rejected. _ Was the advisory group aware that the authors were not submitting a complete review? _ In effect, drug companies are often the advisory group. _ If the authors are asked to revise their paper, they should describe the role of the advisory group and refer to the previous Cochrane review. _ Their findings could conflict with the Cochrane review, which could itself, of course, be flawed, but the authors should include all relevant studies if asked to resubmit a revised version, and to detail why any flawed studies had been excluded. _ Write a frank letter to the authors asking how their review differed from the Cochrane review, and to explain the exact role of the advisory group. _ Transparency is required: ask the authors to declare any competing interests.
The case was referred to the journal’s ethics committee and the matter taken up with both the advisory group and the authors. The authors have not responded to all the editor’s concerns, and the ethics committee feels that it is not in a position to judge whether the authors had been deliberately dishonest. The role of the advisory group was found to be within the bounds of normal practice. Futher follow-up The journal’s ethics committee investigated the case thoroughly and compiled a report, concluding that the paper was muddled but that the authors had committed no outright research misconduct. The editor sent the report to the authors and requested that a copy be sent to the advisory group.
A randomised controlled trial raised three aspects of concern: 1. The participants’ physical characteristics at entry to the study were listed in a table. For the two groups—intervention and control—one physical characteristic was given as a mean ± the standard deviations (SDs). However, the SDs for both groups were much smaller than they should have been. 2. The inclusion criteria were unusual. These excluded half of the eligible population. 3. The intervention was more successful than the control in managing the condition. The language of the paper adopted the style of an advertisement. The company manufacturing the intervention had assisted financially in the study. An independent statistical reviewer did not believe that the over stringent selection criteria could have explained the low SDs. Does COPE feel that these concerns might indicate research misconduct?
_ Was this a simple mistake between standard error and standard deviation? _ Further meta studies should be requested. _ Further clarification from the authors should be obtained along with a request for the original data.