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Ethical oversight

Ethical oversight should include, but is not limited to, policies on consent to publication, publication on vulnerable populations, ethical conduct of research using animals, ethical conduct of research using human subjects, handling confidential data and ethical business/marketing practices

Our core practices

Core practices are the policies and practices journals and publishers need, to reach the highest standards in publication ethics. We include cases with advice, guidance for day-to-day practice, education modules and events on topical issues, to support journals and publishers fulfil their policies.
Case

Research involving unethical animal experimentation

00-18

A manuscript was submitted which described an intervention that partially corrected the results in stress injury in an animal model. Two reviewers drew attention to the fact that the stress model used in these experiments would not be ethically acceptable in the UK.

Case

Clinical misconduct(?), incidentally discovered

00-15

An author submitted a speculative article offering a new explanation for the aetiology of premenstrual syndrome, and a new suggestion for its treatment. The paper was wholly based on a priori reasoning, rather than evidence. It was rejected. The authors appealed, citing as evidence in favour of publishing their paper that they had had successful results treating two patients with the proposed medication—corticosteriods. The dose used was not stated.

Case

The missing ethics committee and lack of written consent

00-14

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.

Case

Authorship dispute

00-13

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 from the published article.

Case

The hazardous drug used in an unlicensed way

00-10

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 for its use, yet the author gave it to them in a quasi-experimental way.

Case

A paper describing a case of possible medical negligence

00-08

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 this was negligence, and the question for the journal is whether any action should be taken.

Case

The single author, randomised controlled trial

00-04

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 was also worried that there was no mention of other standard treatments.

Case

The overlapping papers with conflicting data

00-02

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 seem to be any justification for publishing three papers rather than one or two. 2.

Case

A surgical series that is scientifically meaningless, has no ethics committee approval, and does not mention informed consent

00-01

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 of ethics committee approval and no mention of informed consent.

Case

Invasive intervention without consent

99-24

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.

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