I analysed the results of a randomised controlled trial that had just been completed by some of my colleagues. The trial compared an oxygen radical scavenger with a placebo in patients with acute myocardial infarction. One of the major outcome measures included infarct size,as measured by nuclear imaging. My analysis showed that there was no significant difference between groups for either of these parameters, but statisticians from the pharmaceutical company involved concluded that the treatment provided significant clinical benefit. The main difference was that they had performed within-group analyses,which showed a significant reduction in infarct size in the treatment group. The study had already been presented at conventions using this analysis. I maintained that the within-group analysis was not only inappropriate,but misleading,and even unethical. I suggested that because of the small sample size (around 60 patients), they should be happy that the results leant towards a benefit for treatment, and what they really needed was a larger trial. Unfortunately, the study contract forbade publication without the drug manufacturer’s permission. I contented myself with the thought that I had prevented the publication of wrongful claims, and we continued to lecture that there was insuf?cient evidence for the use of this drug in coronary artery disease. To date, the drug continues to be a best seller. The story then hit the headlines, when it was published in a journal. The concession to its publication had been the inclusion of some statements pointing out that the conclusion was based on within-group analysis. I was appalled. How could they purposely publish a misleading claim, and ignore all references to alternative analyses? The problem is compounded by the following: The principal instigator is a senior cardiologist,professor emeritus in our college,and a leading figure in heart associations. He sits on many committees that approve funding for projects (some of which are mine). He has lectured far and wide that the drug is actually effective. The editor is a good friend of his. What should I do?
This is not within COPE’s remit as the case was not submitted by an editor. Suggest that the complainant submit a letter to the editor of the journal concerned. A systematic review of published studies would expose the flaws.
A paper published in journal A in 1990 was published almost verbatim in journal B the following year, and yet again in journal C in 1993. None of these publications made any reference to the others. The case emerged in the process of one of the authors applying for a professorship. The authors conceded their error when tackled on the issue. One editor agreed to publish notice of duplicate publication, but difficulties were experienced tracking down the third editor.
Notice of duplicate publication should be published across all three journals, preferably simultaneously.
A consultant in public health and a consultant clinical biochemist employed by a health authority submitted a paper. It sought to address the question of benzodiazepine abuse and re-sale on the black market. The authors identified the practices with the highest prescribing rates for benzodiazepines, and asked GPs to agree to request urine samples from patients with a benzodiazepine prescription.The paper presented no clear patient selection criteria, except that cases were selected by GPs according to whether they felt confirmation of compliance would be useful.They found that only 83 of 158 patients prescribed benzodiazepines had positive urine samples, and concluded that “random urine testing is a good idea.” The paper did not make clear whether the prescriptions requested were first or subsequent prescriptions. No mention was made of ethics committee approval or of patient consent. When these issues were raised with the authors they responded very promptly, agreeing with the concerns. They argued that it was a mistake to have called this piece of work a study.They outlined the background of concern which led to this piece of work, and argued that rather than a study, their work represented a decision to extend the availability of urine testing for benzodiazepines to three practices that were under considerable pressure at the time.They argued that they did not see this as a research project, but as a means of coping with a difficult situation by extending to these practices good practice and facilities already available to the community drugs team. Cost considerations, they said, had prevented open general practitioner access to urine testing for drugs. This, they said was why they did not submit the proposed change for ethics committee approval. There was also no specific consent sought from patients other than the standard consent obtained under a doctor’s duty of care. They argued, however, that the testing of urine for drugs of dependency is standard practice for a community drugs teams, and in general practice, in some cases. The authors requested advice on to how to present such a piece of basic public health work in an ethical manner. They also asked what were the ethics of publishing pieces of work that were never intended as research, but which turn up important information; and conversely, what were the ethical implications of not making available important information arrived at during routine work, and how one should deal with the ethics of obtaining genuine informed consent from patients for a test that is being used to assess their honesty. The responsible editor thanked the authors for their swift reply, but pointed out that on purely scientific grounds the journal did not want to publish the study. What is COPE’s view of the ethics of the authors’ actions? How else might the editors respond to the questions they raise? Should the journal take any further action?
_ Explain that this is a study for which ethical committee approval is needed. _ Tell authors they have misbehaved, although we can understand how it happened. _ Don’t involve GMC, but tell authors that if they want their work to be considered as research, they need to design a proper study and obtain the appropriate approval. _ The health authority funded the study: should they be informed? If the health authority’s consent were obtained, it would make a good illustrative case study to report. _ Journal to write an editorial to raise awareness of the issue.
A notice of duplicate publication was issued. The paperwork for the case was lost, stimulating the journal to adopt a different filing system.
A paper from Taiwan was reviewed and accepted for publication. However, one of the reviewers raised the question of ethics committee approval. When the editors checked with the authors, they responded that there is no ethics committee at their university and they were therefore not able to seek ethical approval. What is COPE’s view on this? The study was fairly straightforward involving a questionnaire, some simple lung function, skin, and blood tests.
Can we verify that there is no ethics committee at this University? Taiwan does have ethics committees and the authors should know that they need such approval. It must be made clear to investigators that their work will not be published without ethics committee approval. The editors should contact the authors and tell them that their paper cannot be considered for publication.
A paper by Turkish authors was submitted to journal A. The paper was virtually the same as one published in the equivalent US journal B of the same specialty,but with different authors. The paper submitted to journal A seems to have been plagiarised from the paper published in journal B. The editor has written to the deans of the faculties of medicine to which the authors are attached. What more should he do?
It was agreed that the editor should have written to the authors for an explanation first. Only if a satisfactory reply was not forthcoming should the editor have contacted the deans.
The editor received no response from the deans of the faculties of medicine to which the authors were attached, and no response from the authors.
A paper was published for which the authors’contributions were as follows: A and B had the original idea and planned the study. A was also responsible for collecting the samples and patient data. C established the database and participated in planning the clinical trial. D developed the enzyme linked immunoabsorbent assay and analysed all the samples. E and F were responsible for the statistical analyses of the data. The paper had been written jointly by B, G, D, H and A. A and B were guarantors of the study. D complained to the Danish Committee on Scientific Dishonesty, arguing that the contributor list had been altered from what had been agreed by the authors. The Committee upheld this complaint and the journal agreed to publish a correction to the contributor list, as follows: A and D took the initiative to the investigation. A collected the clinical material. F updated and validated the clinical data, which was initially registered and arranged by C. F and D analysed in cooperation the samples for PAI-1. F and E conducted in cooperation the statistical analysis. F, B, D and A interpreted the statistical results. A and B wrote the first draft of the paper and were in charge of the final manuscript. All authors actively participated in discussions regarding the conduction of the work and in preparation of the final manuscript. The findings of the Committee have subsequently been disputed.
A paper was published in January 1998,and seven authors were credited. B was thanked for his contribution in the acknowledgements section. One year later B wrote to the editor, outlining two alleged incidents related to this paper. First, the cohort reported in the January 1998 paper was one that B had been working on since the early 1990s. In 1992–3 he sought collaboration with another research group. A grant was applied for and granted. At that time B, who was a co-signatory on the grant application, moved abroad but the grant specifically included money for him to travel back to his home country to continue the collaboration. Moreover, all the collaborators agreed that he would be a co-author of all subsequent papers. As the collaboration proceeded, B felt he was being edged out of the group. A senior colleague in his home country felt the same way and eventually resigned from the collaboration. B was unaware that a paper was being prepared for publication from this study. The first time that he saw the paper was after publication. He only contacted the editor after several colleagues urged him to bring the matter out into the open. Not only was he not included as a full author on the paper, but his permission had not been sought for acknowledgement, in direct contravention of the Vancouver Group guidelines. The second allegation concerning this paper is that the hypothesis subtly shifted between the grant application and the published paper. The hypothesis as stated in the grant application is different in an important way from that stated in the introduction to the paper. The results of the research support the hypothesis as cited in the paper,but directly contradict the hypothesis as cited in the grant application. B alleges that the research group concerned has indulged in post hoc hypothesis generation so that the results reflect their beliefs about the meaning of the data rather than their pre-specifed hypothesis. Another paper from this research group,in which B is cited as an author, again without his permission, is currently being held by the editor of a specialist journal pending the outcome of this particular case. All of the co-signatories and collaborators on the original grant application have been asked (with B’s permission) for their view on the allegations. A further complication is that although the grant awarding body has a procedure for dealing with allegations of misconduct, one of the authors of the paper is one of their unit directors.
The editor was advised to inform the grant awarding body of this case and tell them that he had referred the matter to COPE. The editor should also urge the grant awarding body to act with some urgency and, that given the circumstances, the initial investigation cannot be referred to the unit director. The editor should await responses from all collaborators and authors and then show them to B. It was agreed that editors should not get involved when authors fall out but the fact that the paper is published has involved the editor.
The editor heard from all of the authors that the individual making the allegation knew about the work all along and they refute his allegations. Their response to the editor’s challenge about the hypothesis change was that that was the nature of scienti?c progress. However, from the responses,it is clear that there has been a major falling out between the two sides of the collaboration. However,this team did not agree with the allegations either. The senior author now feels that the editor is “destroying”the collaboration and that all parties should get together and discuss. In addition the editor has now been contacted by an editor of another journal who has received a paper from the same stable which has problems around authorship.
Advice on follow up:
COPE advises that the editor should now: Go back to the person who made the original allegations and get his response to the above. Discuss this with the grant awarding body. Involve the journal ombudsman. Invite a representative of the grant awarding body to attend a COPE meeting so that the case can be considered in its entirety. Inform authors and heads of institutions and research council that COPE are considering this case. This gives a line of accountability. The journal ombudsman felt that there was nothing further the journal could do. Two representatives of the grant awarding body attended a COPE meeting. They agreed to instigate an investigation and to raise additional questions about the change in hypothesis with the authors. The grant awarding body has clear procedures and guidelines for research misconduct and they will be revising these to clarify the issues of authorship.