- Case
Consent to publication for case details, and potential for journal violation of patient anonymity
We received a paper reporting on the outcomes of treatment of an individual with obsessive–compulsive disorder and body dysmorphic disorder, which seemed not to respond to standard treatment. Following ethical review and approval, and individual consent, the individual was treated with several distinct courses of an experimental therapy. The individual’s clinical and family history, and their o… - Case
Randomisation and ethics of pilot trials
We received a paper with potentially important results. After review and revision, we accepted the paper. On further reflection, and asking more of the authors, we became concerned. It is an RCT and the only protocol available was slim but appeared authentic. There were two protocols: one for a pilot trial and, if that was positive, a second protocol aimed to randomise more people. One residual… - Case
Incorrect allegations from the head of an institute?
After a number of appeals and revisions, and having satisfied ourselves about the results being “too good to be true”, we eventually accepted a paper. In September 2007, we received a letter from the head of the institute (and also a member of the university ethics committee) expressing concern about the paper. The allegations were: the funding source could not be that acknowledged; the authors… - Case
Allegation of fraud and insider trading
A manuscript was submitted to our journal describing a clinical trial funded by a commercial sponsor with almost all authors being either employees or having financial ties to the company. Although generally favourable, during the extensive peer review process several reviewers raised concerns about the data being “too good to be true”. The editors sought additional statistical adv… - Case
Retraction of article from 1994
Professor A and professor B has been in a dispute over a certain type of treatment for over 15 years. Professor A has accused professor B of killing a patient while he was (in professor A’s view) doing research on the patient without consent. Professor B has accused professor A of research and publication misconduct because he published a paper in journal X in 1994 that included a selected grou… - Case
Potential case of plagiarism
One of the referees of our journal has brought to our attention a potential case of plagiarism. The referee feels that the a manuscript submitted to our journal, representing a retrospective study of a cohort of patients with a particular condition, plagiarises an article published in another journal in 2003. The authors are from an institute in a middle-eastern country. The submi… - Case
Sponsorship, ethical approval and consent for study done as part of an expanded access program
We received a paper describing the results of an analysis of pathogen gene sequences from patients who had been given an investigational drug as treatment for their infection. The study had been done in Europe. One reviewer said that the paper did not explain whether the patients had been treated in the context of a trial or not and that no information about study sponsorship, ethical approval… - Case
Researchers give an experimental therapy to patients based on a laboratory study published in our journal
We published a paper in the journal which reported on microarray expression profiling of cell lines from a specific type of cancer (not named here, to preserve anonymity). That paper suggested that a particular compound might affect the function of a protein expressed in the cell lines; this compound could therefore be a possible candidate drug for use in this type of cancer, which might be exp… - Case
Possible case of fraud
A paper was submitted to us describing an RCT carried out in a Far Eastern hospital. Soon after the manuscript had been sent out for review, one of the reviewers sent a letter alerting us to a “possible case of fraud”. The reviewer in question appears to have compared notes with another investigator in his institute, and together they realised that the same group had submitted two… - Case
An investigation into results that were “almost too good to be true”
A general medical journal received an RCT from a seldom-published, single-author, in an eastern European country. The results were striking, with an effect size that surpassed that of established medications for this condition, so the manuscript was sent for peer review. One reviewer commented that the results were “so highly statistically significant it is almost too good to be tr… - Case
Is ethics approval required?
The journal received a paper on an imaging technique which reported changes in a normal healthy volunteer. No adverse events were experienced. This study demonstrated the feasibility and safety of the imaging studies in a particular condition. The paper was rejected on methodological and priority grounds but during the review process it was noted that no specific mention was made of ethi… - Case
A survey of doctors’ opinions, with no IRB approval or written consent
A doctor who trained in country A took the licensing examinations in country B because he wished to work in country B. After the examinations, he carried out a survey (with a very poor response rate) of other doctors who had taken the same national licensing examination. The survey asked four major questions: How representative was the examination relative to the scope of your reading?… - Case
Unusual consent process in a vulnerable population
A clinical trial was conducted in a low income country. The trial involved two schools. At the first school (the control school), children would receive a one-off drug treatment for a common infection (such “mass drug administration” is the norm for treating and breaking the transmission cycle of this infection). At the second school, children would receive the same one-off drug treatment plus… - Case
An appropriate response to concerns of research validity
A paper describing a novel technique was submitted. Three out of four external reviewers felt that the results could not be true. The manufacturers of the tool used in the technique provided evidence to support the reviewers’ claims that the results were not feasible. The editor wrote to the authors asking them to explain their results. The authors replied saying that they were unable to… - Case
HIV testing without offering treatment to affected individuals
A team of Western researchers carried out a longitudinal study of pregnant nomadic tribeswomen in Africa between 2002 and 2003. They took blood samples during and after pregnancy to test for a specific disease. Those who tested positive were treated. An attempt was also made to trace contacts, and the women’s status was rechecked after pregnancy to ensure effective treatment. The resear… - Case
Studies where there is no research ethics committee, or where committees disagree as to the need for approval
The editor of this journal, in common with other journals, requires that, where appropriate, studies published should have been approved by the relevant ethics committee. In some cases researchers have reported to the editor that they have found no committee willing to accept competence, or that different committees are taking different lines on which studies require approval. As an exam… - Case
Effect of the British Human Tissue Acts on biological monitoring
Biological monitoring is a common procedure in assessing the dose of contaminants from a workplace atmosphere. It may include measuring a contaminant, such as lead in blood, or a resulting metabolic product, such as mandelic acid in urine following styrene exposure. A related process is using adhesive tape to strip the surface layer of a small area of skin to measure the dermal deposit. Clear… - Case
Confidentiality and privacy issue
A manuscript was submitted from UK authors. The study was a case series of infants with a particular condition. A table in the manuscript contains descriptive data which are critically important for the readers with respect to understanding the risk of this condition in young infants and the likelihood of abuse. The question is whether this table violates the law with respect to confiden… - Case
Plagiarism case
A letter was sent to the editor indicating that three articles (one of them in the editor’s journal) on identical subjects had been published in the same year (2006) by the same authors, accusing the first author of all three articles of stealing data from and plagiarising a previously published article from the academic institution where the first author previously worked. The letter, sent by… - Case
Lack of patient consent for a case report, patient confidentiality
A case report was submitted to journal X reporting on a child who had been admitted to hospital suffering an injury, which the doctors suspected resulted from a deliberate cigarette burn. This was not proved until the child returned to hospital with other non-accidental injuries, and following a full criminal investigation the child’s parents were convicted of child abuse. Patient consen…