An editorial was commissioned from a distinguished doctor who was subsequently found guilty of research misconduct overseas. There was a lack of consensus in the journal’s country as to whether this judgment was correct. The author continues to work, but is awaiting a judgment from his regulatory body. - Should the editorial be published? - Should the editorial be published with a footnote referring to these events? - If so, what should this footnote say? - Should the editorial be rejected on ethical grounds?
- The commissioned editorial did not arise out of the issue of misconduct for which the expert was found guilty of research misconduct. - It would be unfair to prematurely pass judgment and the journal should hold the editorial until the regulatory body had given its own judgment. - Hold the editorial until the regulatory body has given its judgment.
A paper submitted to an international medical journal was reviewed externally and the authors were subsequently invited to submit a revised version. The initial submission included authors from two different research institutions and one author from a corporate sponsor. The initial submission was accompanied by an appropriate description of the individual authors’ contributions, a negative conflict of interest statement, and an appropriate acknowledgement section. When the revised manuscript was submitted, the covering letter stated that to comply with the requested revisions and with the International Committee of Medical Journal Editors’ definition of authorship, the list of authors had been amended, but that this amendment could be renegotiated if the editorial team considered that necessary. The amendment involved the removal of all the authors from the second of the two research institutions, leaving the authors (a husband and wife) from the first research institution and the funder. The second research institution was now only mentioned in the acknowledgement section. The conflict of interest declaration had also been changed in the revision, stating that the remaining authors had filed a patent application for the technique described in the manuscript. The paper was subsequently re-reviewed internally and externally and a further revision of the manuscript was invited and submitted accordingly. The final version of the paper was accepted for publication. At proof stage, the senior author from the second research institution contacted the journal to enquire about the progress of the manuscript. During the course of this discussion it became clear that neither he nor his colleagues were aware that they were no longer authors, nor that the paper had been accepted for publication. On their instigation an investigation was initiated by the appropriate authority at the first research institution, and subsequently by the federal government, because the second research institution had received government funding for the project. On discovering the authorship dispute, the journal cancelled the planned publication and informed the corresponding author that the authorship dispute would have to be resolved before publication could be considered. The remaining authors at the time of acceptance initially refused to cooperate with the investigation and formally withdrew the manuscript. They also requested that the journal should not communicate with the authors who had been removed and should not provide a copy of the revised manuscript to any external party. The journal cooperated with the investigations and released information on the paper despite this request.
- The journal had been correct to cooperate with the institutional investigations despite the authors’ objections. This was an example of the public interest overriding the duty of confidentiality between editor and author. - Usually institutions have significant rights over work done internally. - Some journals write to “removed” authors to double check that they have agreed to this. - Major changes in authorship, including priority of authorship, should prompt journals to question authors further.
An article written by eminent doctors on a subject of great public interest, with implications for public health policy, was published in Journal A. They subsequently wrote to Journal A, indicating that an article had been published in Journal B, which heavily plagiarised theirs. The editor of Journal A wrote to the authors of the second paper, but has received no satisfactory replies. The second paper claims to report the results of examinations of 30,000 people and is therefore the largest epidemiological study in the field. The editor of Journal A, who is an expert on the issue described, suspects that the study could not have been done with the financial or logistical resources available to the authors. The authors include at least seven whose institutions are nowhere near the location of the study, and their contributions are not mentioned in the manuscript. The work would have had to have been carried out in a public facility, but when the editor wrote to the head of that facility, s/he knew nothing about the study. A literature search revealed that the same group of authors had published several papers claiming to have investigated large study cohorts. The editor suspects that such large pieces of work would have been very difficult, as the authors would not have had enough, time, patients, or funds to support these studies. The authors have also published many other studies detailing the results of other controlled trials. Cursory examination of these reveals many similar patterns and deficiencies between the number of potentially available patients and the extent of the cohort reported. The editor has detailed his concerns to a national body in the field. What should he do now?
- The editor should write up a detailed critique of the papers. - The editor should contact Journal B to get the article retracted.
A journal published a highly critical obituary, which provoked uproar and prompted the deceased’s family to complain to the national body responsible for regulating the media. The journal believed that the basis of the criticisms were accurate and acknowledged that it had not cited sufficient evidence in the obituary. The journal was considering whether to publish the evidence in full. The journal used journalists to write the main obituaries and considers it important to publish all aspects of a person’s character.
A critical obituary is permissible so long as it is accurate and does not deliberately set out to upset the deceased’s friends and family.
A research article published some time ago detailed an invasive test. The authors obtained informed consent from the patients, but did not seek ethics committee approval. Subsequently, the journal published correspondence from X, detailing the article’s problems. X and others had attempted to replicate the study and had failed to achieve the accuracy levels as described. X stated that this was not an established clinical test and that there had been no prior publication of its application for the purpose stated in the paper. Additionally, the authors did not have the certification required to use the test, and the patients had a condition which affected them neurologically. Although problems with the article were published only six weeks after it first appeared, the authors could not produce the raw data for the investigation. X stated that the national regulatory body had stated in correspondence with him that it would leave it to the journal to decide on whether there was fraud or not. The editor stated that this was not the journal’s understanding of the national regulatory body’s judgment. The journal decided to wait for the outcome of the national regulatory body’s investigation. The issues were complicated by senior members of the authors’ institution accusing X of disparagement, which initiated a further investigation by the national regulatory body. X was cleared of this charge. The investigation found no hard evidence of fraud. The journal’s editorial committee has repeatedly discussed the issue and feels that it should publish the findings of the national regulatory body and ask the authors to reply.
- To retract a paper, there needs to be irrefutable evidence of fraud in the public domain, and the only body capable of exercising due process in this matter had made no definitive ruling on fraud. - A notice withdrawing aegis also requires proof of misconduct as it amounts to the same level of accusation. - X should write to the journal and include the correspondence from the national regulatory body, provided he is happy for this to be published. - The authors should be given the right of reply, as should the national regulatory body. - The journal should take legal advice in regards to the above.
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.
A short obituary for a recently deceased doctor was received. Just before the issue went to print, one of the editors recognised the deceased as having been at the centre of disciplinary proceedings for having had a sexual relationship with a patient. As a result, he had been removed from the medical register for professional misconduct around two years before his death. This was not mentioned in the obituary, nor had the deceased’s brother, who had written and submitted the obituary, advised the editors of this. The proceedings had, however, received extensive media coverage. The deceased had had a 40 year, otherwise distinguished, career as a consultant psychiatrist. Members of the editorial committee had differing opinions about what should be done. - Publish the obituary unchanged: nobody tells the truth about the dead. - Publish the obituary with a note that the deceased retired following disciplinary proceedings. - Refuse to publish the obituary and establish a policy that obituaries of doctors who have been deregistered for professional misconduct will not be published.
- An obituary is not necessarily a plaudit for the deceased. - Medical journal culture has tended not to speak ill of the dead, although this does not sit well with an accurate scholarly record. - Instead of running a negative obituary, the journal could instead run a news piece on the doctor’s general story or focus on the misconduct. - The journal shouldn’t publish a piece that represents the doctor as something he was not and which left out an important and serious fact of his professional life.
The journal offered the brother an opportunity either to revise or withdraw the obituary. He chose, somewhat unhappily, to withdraw it.
A published study reviewed the use of particular devices for performing a clinical manoeuvre. One of the authors worked for a consultancy, but declared that he had no conflict of interest. Subsequently, the journal received a letter pointing out that the consultancy had been set up explicitly to persuade governments and their regulatory organisations of the virtues of new drugs and technologies. This editors felt that this was a conflict of interest that should have been declared, and asked the author if he agreed. The journal’s advice is that if there is any doubt authors should declare an interest as there are rarely any problems taking this approach. The author explained that he had moved jobs after carrying out the research and writing the paper, but before the peer review and publication process had occurred. The author had cited his current address as being the place of contact. The journal is considering publishing a notice of undeclared interests, but should it do more?
Many authors are unclear as to what constitutes a conflict of interest, and a balance has to be struck between exactly what should or could be declared. - The journal does not need to take further action other than that suggested by the editor. - The editor should consider publishing an editorial in the journal to help clarify the issue for authors.
The authors of a paper published in another journal wrote to the editor of Journal A, complaining of apparent blatant plagiarism of their work by N et al. , whose paper had been published in the journal earlier in the year. Further investigation revealed that the text of the two papers was almost identical. S et al. had used one drug and N et al. had used a different one of the same class. The published results in the second paper closely matched those of the first. The paper also seemed to have been copied entirely from the first paper, including the ethics committee approval. The editors wrote to N et al. asking for an explanation, evidence of the raw data, and copy of the ethics committee approval. The time line of ethical approval, submission, and publication meant that it would have been difficult to have recruited for, and completed, an eight week treatment study. N responded, stating that ethical approval was not required even though it was a double blind, placebo controlled study in children, and so had not been sought. The author also claimed that the lack of response from the ethics committee was synonymous with approval. The author then claimed to have sought ethical approval retrospectively, and a letter from the ethics committee was sent to the editors. When the editors attempted to contact this committee they were passed onto another ethics committee in a different area. The letter was sent to the author’s institution head. Unsigned letters and emails, purporting to be from the co-authors’ head of institution, were sent to the journal, and the author supplied an Excel spreadsheet detailing data from just 15 patients. A review of the author’s publication history revealed that s/he had changed “routes” over the past 5-6 years, publishing only fairly brief reports.
- The letter from the ethics committee chairman might have been fabricated. - A spreadsheet on 15 patients is unacceptable; the original data should definitely be available for such recent research. - The editors should write directly to both the current and previous institution heads. - The editors should also consider contacting the author’s regulatory body. - The journal should also write to the co-authors’ head of institution as they seemed to have taken complimentary authorship. - The journal should retract the article if it felt that there was sufficient evidence to suggest fraud; but if not, it should certainly publish a notice of concern.
A case control study that links miscarriage to a particular event was published in Journal A. The paper says that most women were pregnant when interviewed. Whether or not they had miscarried when interviewed matters because of “recall bias.” In fact, most of the women who miscarried had already miscarried and so were not pregnant. The statement that most of the women were pregnant is “true” because all of the controls produced live births and were pregnant. The statement is thus misleading. Journal A was alerted to the problem by an editor from Journal B, which had accepted, but not published, a paper from the same authors with the same design. Their reviewers had identified the problem, and the authors were asked to change their wording. The editorial team of Journal A felt that the authors should have alerted them to the problem when it was flagged up by Journal B, as it may well affect the validity of the results. Should the authors have made the same change in the Journal A study? Might they be actively misleading readers? Should any action be taken?
_ The authors should have come back to the editorial team about the problem. _ Such a change warranted at least an erratum in the journal and the editor should go back to the authors and ask for an explanation. _ The editor felt that the authors should publicly apologise for their actions but felt that these probably did not constitute a serious enough breach to retract the paper. _ The editor should copy his letter to the head of the institution in order to raise awareness in the institution.