- Case
A case report of an experimental therapy, submitted by the patient
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 o… - Case
Sufficient consent?
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… - Case
Legal advice
We have just had a paper submitted as an ethical debate in which the author details ethical concerns about a study previously published in another journal. The study involved complementary/alternative therapy for an infectious disease in children. The author alleges that the study gave insufficient protection to vulnerable subjects, who were exposed to unwarranted risks and discomfort; and that… - Case
No control group, arbitrary dosage, undiagnosed condition
In summary, we have a case series, with no control group, of patients with different conditions treated for an undiagnosed underlying condition with an arbitrarily prescribed dosage of a drug which is not registered for treating any of the conditions nor the undiagnosed underlying condition. I rejected the paper for publication and let the author know that the ethics committee of the journal wi… - Case
“Medical research” using data in the public domain
Information on competitors participating in a popular sporting activity was obtained from a website in the public domain. The authors used this data to see if the competitors' personal characteristics (height, weight etc.) affected their chances of winning. The editor asked the authors how they obtained consent from the competitors for this study. The authors responded saying that this data was… - Case
Ethical approval procedural lapse
An observational study submitted to an institutional journal was sent for peer review. The authors were invited to submit a revision six months later. They did so, but had not responded fully to the reviewers' points, so they were asked for further clarification of their selection criteria, publication plan, and evidence of ethical approval. A paper by the same authors describing the same cohor… - Case
Consent and ethics approval questioned after acceptance
In a paper detailing a physiological study of healthy human volunteers the authors stated that ethics committee approval had been granted and that the participants had given informed consent. After peer review the paper was revised and accepted. During the production phase the journal received an email from a researcher who was reviewing another paper from the same authors for a differen… - Case
Ethical approval and fabrication of results
A group of authors, based in private practice, submitted three manuscripts to Journal A and one to Journal B. All the manuscripts described the application and effectiveness of a spinal manipulation technique. The first manuscript in Journal A was a case series of 21 patients. After publication, a member of the journal’s editorial board pointed out several flaws in the study design, incl… - Case
Interactive case report of a patient with ongoing health problems
The case of a patient with unresolved upper abdominal pain and weight loss was written up and submitted by her family doctor to a journal that publishes interactive case reports. The intention was to present it as an unfolding story in three parts over five weeks. Responses would be invited on the journal’s website from readers to questions about diagnosis and management, and about what to say… - Case
Case report and consent
A journal provisionally accepted a case report. When requested, the authors could not identify patients to obtain their signed consent. The authors offered to anonymise the data, but the journal was inclined to decline. - What should the editor do?… - Case
Interpretation of regulations: when is a waiver of authorisation acceptable?
Some authors tested the effect of a food on the menstrual cycle. The manuscript included patient identifiable information, but the authors did not provide formal confirmation that the patients consented to publication of the study. Information was sent to the corresponding author, outlining legal obligations in respect of patients' consent to publication. But the authors stated that they consid… - Case
Plagiarism in a review article
A review article was spontaneously submitted and sent out to three peer reviewers, which is standard practice for the journal. One of these reviewers expressed “serious concerns” about the paper. In a telephone conversation, s/he explained that the structure (headings, subheadings, etc), large “chunks of the text,” and most of the references had been plagiarised from a teaching syllabus that s/… - Case
Online trial of a new diagnostic tool
A paper was submitted that attempted to evaluate a new tool for diagnosing an acute symptom. This symptom is one that could be linked with various medical conditions—some causing little harm and some life threatening. The researchers recruited (and continue to recruit) patients into the study through a website devoted to this symptom. Patients viewing the website are asked if they would like to… - Case
The case of a physician in private practice offering an experimental intervention
A physician in private practice wrote to our journal asking if we were interested in a paper discussing his experience of offering a novel intravenous therapy to his patients. He hoped we wouldn’t discriminate against him for being an author in private practice. He had given this therapy to nine patients with a variety of acute and chronic illnesses, including himself. The physician says that a… - Case
Possible malpractice revealed in a case report
We received a case report describing the diagnosis and treatment of a middle-aged woman who presented to a gastroenterology service in England with weight loss and a right iliac fossa mass. The authors did a barium swallow, duodenal and gastric biopsies, and diagnosed Crohn’s disease by the radiological appearances on follow-through. They did not do a colonoscopy, or biopsy the mass in the term… - Case
Lack of ethics committee approval?
An editor received a paper and requested details of ethical approval from the authors. The authors replied that they had approached the ethics committee about carrying out a more extensive study than the one submitted, for which ethical approval was denied or possibly thought unnecessary - the authors’ English isn’t clear in their responses. Before the start of the more extensive study, the aut… - Case
Obtaining consent for a study of people with severe learning disabilities
A paper was submitted which reported a study of observing people with severe learning disabilities and their interactions with staff on a locked hospital ward. The journal was keen to consider the paper further, but had concerns about ethical approval. The authors stated in their cover letter that ‘Ethical approval was sought from the Research Ethics Committee, but the Committee deemed that the… - Case
Potentially unethical publication
A new Editor was appointed to a society journal in a minority medical specialty. An officer of the society immediately handed him an anonymous letter from a reader of the journal complaining that an article recently published was unethical. The Editor is a personal friend both of the previous editor who accepted the paper, and the author of the paper. The paper is by a single author who gives n… - Case
Research on volunteers without informed consent or ethics committee approval
An experiment on a volunteer in hospital was written up. The volunteer was an asthmatic who was stable at the time and given a combination of intravenous magnesium sulphate and salbutamol to observe the pharmacological effects. The drugs were given under supervision in intensive care as they carry some risk of cardiovascular side effects. The paper reports: "After discussion with colleagues, a… - Case
Retraction of false authorship
Dr X asked for a statement to be published to the effect that the letter he had published in the journal with two co-authors was not based on any work that he had done, but on that of his colleagues. The editor asked the other two authors why they had signed a copyright form in these circumstances. Both authors stated that they had not signed any such form, and when presented with a copy, state…