- 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
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
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
Compromise of patient confidentiality?
A paper containing three case reports of the same disease was accepted for publication. The disease reported is fairly rare. The parents of one of the cases consented to publication on condition that their daughter was referred to in the paper by her first name rather than as a case number. This particular case has been discussed in the course of a national inquiry, but it is not clear whether… - Case
Ethical status of authors’ actions?
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… - Case
What happens when there is no local ethics committee?
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 quest… - Case
A lost author and a new hypothesis
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 researc… - Case
Retrospective ethical approval?
A paper reported a questionnaire study of patients’ views on their preferences between minimal access and open access surgery. The questionnaires had been given to patients attending two types of clinic. The paper made no mention of ethical approval and the author was asked to clarify. He responded that he had not obtained ethical approval but that he had spoken to the chairman of the hospital… - Case
Confidentiality and conflict of interest
A paper reporting an attitudinal study was sent for peer review. The editor received a letter from the reviewer stating that as he was personally acknowledged in the paper, he felt there was a conflict of interest and so unable to review the paper. The reviewer also pointed out that the research in question was part of a larger commissioned project with strict conditions of confidentiality. Th… - Case
Triplicate publication with possibly different data in each
A paper describing an outbreak of infectious disease was submitted to three journals. The submission to one journal described the index case; the submission to another included investigation and follow up of other cases and contacts in the country where the outbreak had occurred. The third paper looked at the spread of the disease into other countries. A considerable amount of the epidem… - Case
Patients with vitiligo treated with anti-fungal drugs by a general practitioner
A letter was submitted for publication in which a general practitioner described how he treated patients with vitiligo “simultaneously with an anti-fungal and anti-bacterial medicament over a prolonged period.”He has done this because:“As is now known,a fungus resembles the human being genetically and there is a possibility that a fungus can hide in the melanocyte (analogically as is being do… - Case
Unethical research
We have received a study in which patients with healed duodenal ulcers were randomly allocated to treatment with either placebo or ranitidine. Patients were also categorised as to whether they were type A or type B personality; the hypotheses being tested was that patients who were type A might be more likely to relapse. Patients did not have their H pylori status determined. Subjects we… - Case
Failing to get consent from an ethics committee
This case was described to me by an author who is about to submit a paper. He has discovered that a member of his team has produced a lot of fraudulent data for other studies, and has forged consent from ethics committees. This researcher has been reported to the GMC and his case is pending. The problem with the paper about to be submitted to us is that the fraudulent researcher falsely claime… - Case
Unethical research undertaken by a single handed GP
We have received a paper from a GP testing the hypotheses that because 24,25 cholecalciferol has a similar structure to commercially available statins, it may act as an inhibitor of HMA co-reductase. He screened 350 patients in his practice and identified 77 who had a cholesterol concentration above 6.5 mmol per litre. Thirty-three of them agreed to return for a second test 2 weeks later. They… - Case
Not getting consent from an ethics committee
We had provisionally accepted a randomised controlled trial of an exclusion diet given to young children with a particular condition. The trial design was that one group started the exclusion diet a month before the second group. In other words, both were given the “treatment.” One part of the trial was that children who were thought to have an allergy to a particular food were rechallenged wit… - Case
Informed consent
A group of researchers are conducting a study of whether women aged 65 to 69 years will accept screening for breast cancer. They plan to invite these women for screening in the same way as they invite younger women for screening but will not know that they are part of a research study. The authors want advice on whether journals would be willing to publish their results, despite the fact that t… - Case
A commentary on a piece of (unethical) research
We have received a paper in which the authors have exposed a group of babies to physiologically unnatural circumstances. These circumstances do however arise quite regularly in some peoples’ lives. None of the babies had anything wrong with them, but some of them were siblings of babies who had died. Some of the babies showed physiological changes in the unnatural circumstances, which raised th… - Case
False memory syndrome
A doctor has submitted an account of how his daughter falsely accused him of having abused her as a child. His daughter is another British doctor. We would like to publish the account as part of a package of articles on false memory syndrome. The questions we are considering are: (1) Can it ever be right to publish something that describes the intimacies of a family conflict, to illustrate a s… - Case
Living unrelated (commercial) organ transplant
A paper submitted for publication describes a series of children with renal failure who had had kidneys transplanted from commercially acquired donors. The authors of the paper had not carried out the transplants. Indeed, they had been carried out in another country. The authors simply reported what happened to the patients after they returned. The paper, while not of high priority for publicat…