- Case
The missing ethics committee and lack of written consent
A study that helps with the microbiological diagnosis of a clinical condition had been peer reviewed and accepted for publication when it was discovered that the study had no formal ethics committee approval and that the patients had given verbal rather than written consent. The journal contacted the authors, who responded by saying that the chairman of the ethics committee in their area did kn… - Case
Authorship dispute
An article was published with three authors’ names. Not all of the authors’ signatures had been included on the original submission letter. A complaint was lodged by Y, who said that X had submitted the paper without either his or Z’s consent or knowledge, and that there were several specific errors and omissions. Y then submitted a statement for publication in the journal dissociating himself… - Case
Undeclared conflict of interest
A paper on a controversial topic from three authors was published. All three authors completed forms to say that they did not have competing interests. This was stated at the end of the paper. A reader subsequently contacted the journal to say that she had clear evidence that one of the authors did have competing interests. He had, she said, been involved in legal cases and received substantial… - Case
The wrong standard deviations, the over stringent selection criteria, and the overt attempt at advertising
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… - Case
The hazardous drug used in an unlicensed way
The author (a clinician) sent in a case series, involving two patients. Both patients presented with severe pain, which was resistant to strong analgesics. The author then gave them a drug with potentially very serious sideeffects, including a small risk of disability or death. This drug is only licensed for a small number of indications. Neither of these two patients met the clinical criteria… - Case
The study that may or may not already have been published
A study purported to have been stimulated by a systematic review that had already been published in the journal. The new study included 15 patients who had been treated in one arm of a study and 15 who had been treated in another arm. The peer reviewers noticed that the original systematic review included 31 patients from the same authors. The editor contacted the authors asking them to make cl… - Case
A paper describing a case of possible medical negligence
A paper was submitted, describing a doctor who had given an injection of a drug (actually a herbal/homeopathic remedy) to a patient who had already experienced recurrent swelling when given previous injections of the drug. The patient suffered a severe anaphylactic reaction, but survived. The reviewer suggests that it was negligent to give such an injection. It seems at least plausible that thi… - Case
The unacceptable use of a placebo
This was a small randomised controlled trial of a medication for an active inflammatory condition. The trial was unnecessary, as several large trials and a recent non-systematic review had shown that the medication was beneficial for flare-ups of the condition. In this case, all patients were taken off non-steroidal anti-inflammatory drugs (NSAIDs) and then they were randomly allocated to recei… - Case
Paper submitted by a PR company without the knowledge of the authors
A paper was submitted for which there were seven contributors, but no corresponding author. The only identification of who had sent the paper was an accompanying e-mail from a public relations company. When contacted by the editorial office, the PR company confirmed that the paper was to be considered for possible publication. The named contributors were then contacted and asked whether they ha… - Case
Duplicate publication based on government data
A group of researchers from departments of psychology and public health submitted a paper based on a survey that had been commissioned by the NHS Executive. The paper was received at Journal A on 14 May 1998 and a decision to offer publication of a revised version was made on 25 June 1998. Over a year elapsed between this offer and the resubmission of a revised version of the paper due to illne… - Case
The single author, randomised controlled trial
After a randomised controlled trial from a single author had been published, a letter was received in which the correspondent suggested that the original trial might be fraudulent. Firstly, the writer claimed that it was highly unlikely that just one author could perform a prospective, randomised, double blind, placebo controlled trial, especially in a small district hospital. The correspondent… - Case
Editorial compliance with duplicate publication
An editorial that was very close to a paper that had already been published in another journal was submitted for publication. The authors did not make clear that the editorial was essentially the same as the one already published, but this was discovered during the peer review process. Nevertheless, the journal went ahead and published the editorial without disclosing that it was very similar t… - Case
The overlapping papers with conflicting data
Three papers concerning one hospital problem had been submitted to three different journals. Before publication the three editors of the journals became aware of the three different papers and the substantial overlap between them. The three editors communicated with each other and realised that they had four concerns: 1. There was very considerable overlap among the three papers. There didn’t s… - Case
A surgical series that is scientifically meaningless, has no ethics committee approval, and does not mention informed consent
A study from a foreign author was submitted in which he describes a series of patients whom he has operated on to treat their migraine. The operation is something that he has devised himself and consists of suturing a superficial temporal artery. The surgeon has operated on over 1200 patients. There is no clear definition of how the diagnosis was made and no control group. There is no mention o… - Case
Author dispute concerning ownership of data
A paper submitted to Journal X was reviewed and rejected with the recommendation that it be submitted to a more clinical journal. The paper was duly submitted to Journal Y. The authorship was A, B, C, D and E, with E being the corresponding author linking together two research groups in different cities, but in the same country. Journal Y sent the paper to reviewers and, after discussion, thei… - Case
Misconduct on a massive scale?
Almost five years ago two outsiders approached an editor suggesting that a large series of papers from a particular researcher, including some published in high profile journals, might be fraudulent. Those contacting the editor thought it possible that the patients described in the studies had never existed at all. Round about the same time a few papers from this author were circulating in the… - Case
The declared and the undeclared competing interests
An editorial was published on a particular subject in which the author’s competing interests were declared. He had given evidence on behalf of patients making a claim against a manufacturer. Three people then separately pointed out that we had already published a commentary on the same subject in which there had been no declaration of competing interest for the author. The three people all said… - Case
The results that were too good to believe
A study made it a long way through the peer review process before one of the statistical advisors said that the results seemed “too good to be true.” The authors were asked to send in the original data, which the statistician analysed. He remained very concerned about the data. The authors were notified and the journal asked the university to investigate. Has the editor done the right thing? - Case
Invasive intervention without consent
A study was submitted on the safety and feasibility of treating patients with acute stroke with an invasive procedure that would cause them considerable discomfort. The editor did not want to publish the study because it had negative results, did not include a power calculation, and was almost certainly too small to detect a clinically useful difference. The study had obtained local ethics comm… - Case
Publication bias arising from an editor’s activities
The committee’s attention has been drawn to alleged publication bias in Journal X. It is alleged that an editor on X had invited a young trainee in radiology to author some 14 commentaries over the past 5 years. His most recent commentary draws attention to one important study from France but otherwise covers the same territory as his previous commentaries without mention of relevant contrary…