A referee’s report on a paper informed this editor that the authors had submitted a very similar paper to another journal. Both papers analyse the same 30 cases of an unusual neoplasm, and the tables and five of the photomicrographs are identical. There is also considerable duplication of text in the article.
We have written to the authors requesting them to clarify how this has arisen and told them that when such duplication arises it is regarded as tantamount to fraud.
The committee questioned the use of the term “fraud” in these circumstances, saying it implied an action far more serious than perhaps was the case. Fraud suggested that there was a deliberate attempt to mislead or the submission of falsified data. In reality, this was more a matter of misconduct involving a breach of publishing rules. The committee asked if the authors’ were new to writing so possibly somewhat naïve, but the editor confirmed that they had published previously.
It was felt that the most appropriate course of action would be to write to the authors again, in the strongest terms possible, asking for an explanation and giving them a deadline by which to reply. If no reply is received, then the editor should write to their head of department or institution, laying out the facts of the case clearly.
No reply received so letter sent to host institution; no reply as yet. The institution has since replied and is investigating the matter.
Further update (April 2007)
No response was received from the host institution despite reminders, and so after six months the paper was automatically rejected.
A manuscript was submitted to our journal regarding a chart review of a novel treatment of a musculoskeletal disease, done at a private clinic in a western country. The patients had given informed consent for the novel treatment, but there was no ethical approval.
We contacted the authors, who have replied that ethics approval could not be obtained, and indeed was not needed, because the private clinic is not affiliated to a university and because the study was merely a retrospective chart review. The five authors on the paper are all affiliated with universities with ethics committees. We also noted that the owner/director of the private clinic is not listed as an author.
We have also found that on the clinic’s website there is a reference to a “research study” regarding this novel treatment, which was started nine years ago. The retrospective chart review of the submitted manuscript dates back to approximately the same time. We are concerned that this current chart review may be based on a prospective study without ethical approval. We are also concerned about competing interests, as the director of the clinic, who presumably has been performing this treatment, is not listed as an author, nor named in the acknowledgements.
We have written to the authors regarding our concerns and are awaiting a reply.
Should we also contact the authors’ institutions?
Who do we contact regarding ethical practices at a private clinic?
What more should be done?
The COPE code of conduct states that if an editor considers research presented in a submitted paper may be unethical, then the matter should be investigated. This would be so even if ethical committee approval had been obtained. However, contacting the institutions of the authors may not achieve very much as the work was conducted at the private clinic and they are affiliated with outside universities, having been brought in at the invitation of the clinic’s director. Indeed, one of the authors said that his institution had already contacted him regarding the study, independently of the editor.
If the editor feels the study is unethical, the paper should be rejected. The authors’ institutions should not be contacted; however, the appropriate regulatory body for the clinic should be informed about the editor’s concerns, and any investigation should be left to this authority. The editor should ask for a response and make a note that he might need to remind the regulatory authority from time to time.
After much discussion back and forth, we finally understood exactly what was being done to the patients in the research project. While not a completely new therapy, it was a novel application of an existing technique, had not previously been studied, and was not approved for use by any ethics committee. We did reject the paper, but have not heard back from the licensing body of the independent clinic. I have asked for an update from them, however.
A reader contacted the editorial staff of Journal A after noticing that Journal B, which is primarily non-English, had published a paper that was remarkably similar. The editor of journal A contacted the editor of Journal B. Both editors reviewed the two papers and agreed that the paper from Journal B contained methods, results, and conclusions that formed a part of the paper from Journal A.
The authors were contacted by the editor of Journal A and asked for an explanation. They have replied that the two papers were intended for different audiences, and since the paper in Journal A was a more comprehensive study, this did not constitute duplicate publication. The papers were submitted at approximately the same time, and neither paper referenced the other.
The committee felt that the authors’ excuse that the papers were intended for different audiences did not stand up. If the two papers were basically the same, with most of the data in the tables being duplicated (overlapping data) but with an extension of the data in one of the papers, then this was clearly a case of duplicate, or “redundant”, publication. It would have been acceptable for the author to publish both papers, provided permission to do so had been obtained from the editors of both journals, and that the matter was acknowledged in both papers. However, neither paper referenced the other.
Therefore, the committee advised that Journal A should issue a notice of redundant publication. Ideally, the authors should issue the notice, but probably the editor would have to do it. When writing to the authors, the editor does not need to go into great detail, just point out that it has been discovered that this particular study has been published in full or part by another journal, and that consequently a notice of redundant publication will be published in the journal.
This case was resolved by publishing a notice of redundant publication. The author was not willing to write the correction initially, but did approve the final draft that went on to be published.
This journal specialises in one form of treatment. It is the only Medline listed journal that is widely accessed in Europe by people who use this form of treatment. No international journals provide a suitable alternative. In the USA, the one journal most similar to this is much less specialised and hardly ever accessed in Europe.
The journal editor is a leading researcher in this form of treatment. He therefore has a clear conflict of interest in deciding whether to submit, as an author, a report of original research to his own journal. He wishes to establish a means of dealing with this conflict of interest, and would value the experience and advice of COPE.
The journal’s current peer review policy for this type of article is to have two reviewers, at least one of whom is external. It would clearly be possible to change this to two external reviewers for articles from the editorial board. However, there is a conflict of interest even in the choice of external reviewers. “I personally have no problem in selecting “severe” reviewers, but how can I make this be seen to be objective?”
I can find no case discussing this conflict of interest on the COPE website.
The issue here basically revolves around whether it is acceptable for editors to publish their own work in their journals; if it is, then the review process must be made as transparent and rigorous as possible. Certainly there are examples of editors publishing studies in their own journals, particularly in those circumstances where the choice of journals is limited, as in this case. Provided every effort is made to minimise any bias in the review process by having another associate editor handle the peer review procedure independently of the editor (recognising that it would be impossible to remove bias completely), and the process is absolutely transparent, then this would be the most appropriate route to take. It was suggested that the editor send the article out for review without any names on it, but he said the subject field was so narrow and specialised that any reviewer would know who had written the paper. As an extra precaution, if and when the article in question is published, the editor might like to publish an accompanying commentary showing how transparent the reviewing process had been.
The editor was grateful for the advice which is now journal policy.
A paper was submitted describing a novel technique for preparing tissue, which was noted immediately by a referee to be a modification of a method used by another researcher. The other researcher is thanked but is not included in the author list. The referee asks for advice as he feels that he is in a grey area of ownership of an idea and the degree of novelty needed to make it a “new” idea. The referee knows the other researcher and requests permission to enquire whether or not he/she is aware of the new paper.
The committee felt that any correspondence from the reviewer to the other researcher should go through the editor, and it should be the editor’s decision whether or not to contact the researcher. The reviewer should not contact the researcher directly.
Reviewer accepted suggestion and incorporated edited version of comments into report. These have now been sent to authors based on two referee reports with rubric major changes based on the two reports.
Further update (April 2007) The final decision was to reject and resubmit if major changes could be made, including anonymised comment about the existence of the other previous work in the referee reports (as it happens raised by at least two). No revised version has been received.
This is a summary of a problematical research interaction between a pharmaceutical company and academic collaborators at a University involving a widely used drug. A pharmaceutical company appears to have exerted undue influence in an attempt to control the scientific literature.
The research involved an important retrospective secondary endpoint in the three key randomised trials used to prove the efficacy of this drug for regulatory approval.
It is critical to understanding of the mechanism of this class of drugs. The outcome of the research also has practical clinical relevance in terms of choice of drug therapy and therapeutic monitoring. It is pertinent to interpretation of a recent head-to-head trial of this drug versus its main competitor. The information is also relevant to a wider debate about the evidence required for regulatory agencies to licence related drugs.
For the company there was an important issue at stake in terms of the outcome of this research.
This core problem involved refusal of the pharmaceutical manufacturer to provide crucial raw data (principally randomisation and event codes and information about confounders) to clinical academic collaborators. Thesedata were required by the academics to verify scientific reports, statistical analyses, meeting abstracts, and draft publications "ghost written" by the company in their names.
Initial refusal to supply data was compounded by continued refusal even after considerable information emerged to suggest that data analysis and data presentation had been incorrect and misleading. It appeared that "fair" analysis of the data might not have yielded findings desired by the sponsor. This interfered with the ability of the academics to discharge their duties as responsible scientists and medical doctors. It prevented correction of the published literature. It also violated the actual and implied terms of contract between the sponsor and the academic institution.
Later evidence emerged to convince one academic (the intended first author and first author on abstract presentations) that information presented in his name had been misleading. The company and his collaborator then attempted to alter the study hypothesis in retrospect and threatened to eliminate him as author if he refused to sign consent for publication even though he had not seen the data. They maintained that PhRMA guidelines justified their actions and that access of authors to data is not required.
These events were brought into focus by resulting poor collegial relationships, conflicts of interest, and other alleged research misconduct. Collaborators disagreed over the right balance between honesty and the need to secure funding from the sponsor.
What should the editor do next?
The journal could publish the entire story. The paper sounds unpublishable and the study is not hosted by an institution, so there is no apparent investigative body. This was similar to another case where an author objected to the other authors and was hounded out of her position.
It was suggested that this could be a case for the Panel for Research Integrity. The ABPI was also suggested, but it was pointed out that this is voluntary and a ‘toothless tiger’. The HMRA could be another possibility. The committee discussed what the author could do; there were several suggestions, for example - get legal advice orpass the material to an investigative journalist. Also if published the author could write to the GMC concerning any named authors who are on the medical register if he believes the material is fraudulent.
Among the recommendations made by COPE was a suggestion that the author should contact the MHRA and may wish to discuss his concerns with an investigative reporter. It appears that the author took up this suggestion, as a story about the matter appeared first in the Times Higher Educational Supplement and then on the front page of the Observer (a national UK Sunday newspaper) on December 4th. The matter is also being investigated by the Medicines and Healthcare products Regulatory Agency.
The journal commissioned a Seminar that arrived in September 2004 and was sent for peer review. In March 2005, we received a peer reviewer’s comments pointing out a very similar paper by the same authors in another journal, published in December 2004.
On careful comparison, there was over 70% text copied word-for-word, sometimes with trivial alterations, from the previous publication.
When challenged the authors replied in great detail arguing about the exact extent of duplication but also saying this was an ‘honest mistake’ of not disclosing the other paper to us as it was not yet accepted. They still argue for the value of their paper.
We have rejected the paper pointing out that duplicate submission is unacceptable.
Should we do more?
The authors should have self disclosed. The authors tried to defend themselves by arguing that a certain percentage of duplication was acceptable in a review article. It was thought this issue should be taken further. The committee thought that the authors were being dishonest and had tried to fool the editor into duplicate publication and also fool the readers.
The advice was to ake this further–write to the author’s institution pointing out that this sort of behaviour is not in the institution’s interests.
We contacted the author’s institution. The head of institution actually wrote back agreeing that this behaviour is completely unacceptable and that he will ensure that this is understood by all in his institution.
An article reviewing approaches to modelling the impact of widescale therapy for a particular condition was submitted to the journal. The editors mistakenly sent the article to an individual (reviewer A) whom the authors had requested be excluded as a reviewer (the article was critical of some of the reviewer's previous work). Upon realizing this mistake, the editorial board decided that they would disregard that particular review when it was received, even though the reviewer had already agreed to referee the article. No comments were received from reviewer A for over 3 months, and it was assumed that none would be forthcoming. In the meantime, additional reviews were received from other referees. Based on these, the authors submitted a revised version of the manuscript, which was subsequently accepted for publication. The manuscript is currently in preparation for publication.
Following the manuscript's acceptance, reviewer A contacted the editors citing major concerns about the article. In particular, reviewer A was opposed to the authors introducing in a review article a new mathematical model that had not been previously peer-reviewed, and suggested that the authors presented issues that had previously been addressed by others as if it were their own work. If the article had not yet been published, reviewer A requested that publication be delayed until their concerns had been addressed.
The editors wrote back to reviewer A saying that the article had already been accepted for publication and that it would be unfair to the authors to delay publication, as it had already been through peer review. In addition, they explained why they disagreed with reviewer A's concerns. However, reviewer A would have the option of writing a letter based on the published version, to which the authors could then respond. Reviewer A has re-iterated their concerns and expressed an intention to write such a letter.
How should the editorial board handle instances in which an article is sent to a reviewer by mistake?
What are our responsibilities to authors and reviewers in such cases, particularly if the reviewer has some concerns that could be legitimate?
The issue of asking for authors who they would like to exclude was discussed. It was questioned if it was generally allowed for authors to suggest excluding reviewers. Also there was a potential problem in that the option to excludereviewers was shown last on the electronic submissions system, so it was possible to mistake them as possible reviewers. A recent study suggested that author suggested reviewers on average makemore favourable comments. Another study found there was no difference in quality, but author suggested reviewers were more likely to support publication of a paper. It was also pointed out that in some journals, authors were asked not only which reviewers they wanted to exclude, but why, and this sometimes provided important information.
It was also pointed out that the exclusions were only suggestions, the editor could use these people as reviewers if they liked.
The journal should have told the reviewer that the paper was sent in error (which it was). Nonetheless if there are legitimate concerns with the paper, the editor should seek further advice, and put the concerns to another reviewer or the other original reviewers. It was also thought the editor had a duty to pursue any concerns.
Also the editor should change the form on the journals electronic submissions system so that excluded reviewers are flagged and shown first.
We published the article as originally intended. The reviewer expressed their intention to write a letter to the editors in response, but so far we haven’t received anything.
We received a pre-submission enquiry about whether we were interested in publishing a case report of a novel therapy that provided “a complete cure for heart disease.” The therapy involved a “membranotrophic drug” combined with diet and exercise.
The therapy had been given to a patient who had experienced a myocardial infarction. Eighteen months later, the patient was apparently free of heart disease.
The presubmission enquiry stated: “This experimental treatment was at all times under the supervision and with the consent and approval of several cardiologists, a cardiac surgeon and a neurologist.” But there was no mention of whether the patient had consented to receive this “experimental treatment” or whether an ethics committee had approved the n of 1 experiment.
We wrote to the lead author to clarify these two points, and the lead author wrote back to say that he himself was the patient, and that he wanted to spread the word about this dramatic treatment and the “membranotrophic drug.” The article had previously been rejected by four biomedical journals.
It remains unclear whether the patient knew this was an n of 1 trial. He is delighted with the outcome, and is writing up the case, but can we assume that his delight constitutes sufficient consent?
This paper was written in a very oblique form. It is also very unusual, because the author is the patient! The paper is from the US from a private practice and the editor was not able to find out more about the co-authors. The author of the paper was a surgeon. The author of the paper was not able to provide a consent form (signed by himself). The committee thought that was a rather unusual situation, but was concerned if the treatment had not worked. Then the doctors providing the treatment would have been at fault. Other editors shared their experiences of where authors had applied the procedures to themselves and then tried to publish the papers.
The committee thought it was doubtful that the editor could take this any further.
A paper was submitted which enrolled elderly nursing home patients to an experimental study of the effect of a medicinal plant on skin ulcers. Although the plant is licensed for use in other skin conditions, it does not have a specific licence for this indication. The study did not mention ethical approval or whether consent was obtained so the editor wrote to the author to query it. The author replied that the patients were informed that the study was an experimental pilot study, and either they or their ‘tutor’ gave oral or written informed consent after a ‘complete explanation’. However, it is unclear what explanation was given, whether the patients were cognitively able to give informed consent, and whether ethical approval was obtained.
Is the author’s explanation sufficient?
Is oral (as opposed to written) consent acceptable in these circumstances?
It was argued that if there is no consent then the paper should be rejected. In the Netherlands all interventions are reported, and the author would have been questioned why they had no approval. In the UK the GMC might take disciplinary action.
What ever sort of consent occurs, there should be a detailed audit trail - there needs to be some sort of evidence. If this was a UK case then the editor should go to the hospitals clinical director, or the Dean or Head of Department. It should be passed up the line and must be followed up.
This type of verbal consent is unacceptable, there should be a detailed audit trail. The author should receive a stern letter outlining the reasons this is unacceptable and the case should be followed up through the authors institution.
Following the last COPE meeting I went back to the author with the following questions:
1) Was ethical approval sought from the appropriate ethical review committee?
2) The details of consent process for each patient are unclear. Specifically how many people gave written consent? How many people gave oral consent? How many gave consent by proxy, i.e. by their “tutor”? Who obtained consent from the patients? Although oral consent may be acceptable under these circumstances you should have a record of the audit trail e.g. written documentation that consent occurred. Can you provide us with evidence of the audit trail?
3) Can you please confirm where the study took place (the address of the nursing homes) and the institution to which it you are affiliated?
And I received the following reply:
1. The protocol was approved and signed by the medical and nursing teams of the institutions. No ethical committee exists in our institutions. The preparation was already present in our internal pharmaceutical list and used without standardisation. The aim of this preliminary paper was to write a protocol for using it in a standard matter and to document eventually the benefit by photos.
2. Five out of seven patients gave written consent (of which three by proxy or tutors). Two patients gave oral consent. Consent was obtained together by the chief of the nursing team, by nurses, and by myself. The chief of the nursing team signed an appropriate form in the two cases of oral consent.
3. I confirm that the study took place at the nursing homes indicated fully after my name in the documentation send to your journal.
So it's now a question of whether COPE considers his responses sufficient.
Advice on follow up:
The committee noted that the author did not answer the question regarding the institution he was affiliated with. If he was a “tutor” with a higher education facility, then there would be an ethical committee, but in many places there is nowhere to go. However, “tutor” might be a term used for a carer or guardian, so out of COPE’s aegis. It was felt that this issue of research being conducted at private institutions, where there are no ethical committees, was something COPE should focus more attention on. In the meantime, the editor has to consider whether anyone was put at risk as a result of the research conducted. If so, then the matter should be referred to the appropriate regulatory body.
Further update (April 2007)
The editor in chief wrote a letter to the ethics committee. No reply was received. Correspondence with the author fizzled out as it proved impossible to find his institutional address. The journal’s ethics committee said unless there was a risk of harm to patients then a stern letter should be sent to the author with no further action.
The handling editor felt that she had reached the end of the line with this author, and that questioning him further would achieve nothing. It was agreed that there was little point in pursuing the author, but the editor in chief wrote to the author drawing his attention to the details laid out in the Declaration of Helsinki.