Participant consent

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.

A submitted paper detailing the negative experiences of overseas doctors applying for a training post in a district general hospital was poorly presented and scientifically weak, but on a topic of great interest and importance. The study consisted of an analysis of the CVs of the applicants and an analysis of responses to questionnaires sent to them with their rejection letters. Over a third of the questionnaires were returned.

A case report was submitted to a journal, describing a patient with a very serious, curable infectious disease who had been given complementary medicine (plant extract) rather than the standard treatment. A search of the literature indicated that the authors were known to support complementary therapies. The alternative treatment was not evidence based. The case took place in a country were the standard treatment was easily available.

A paper was received, which detailed a research project conducted on newborn babies, which involved taking an invasive (and painful) sample from them. The paper was worthy of publication from the point of view of scientific value, but two issues worried the editors. First, it was unclear whether the sick babies’ samples were going to be used as part of their clinical management or whether these samples were taken simply for the trial.

Journal A received a letter from a reader claiming that a figure in a paper published in the journal had appeared in various guises in three other learned publications over the course of 12 years. The origin of the figure was disputed and the reader believed the original source was not the authors. The authors of the paper in Journal A were asked to comment. They refuted the claim.

A study was submitted in which the authors describe a new surgical technique, which includes radiofrequency coagulation, to treat complete prolapse of the rectum. They say in their paper that: “in the treatment of complete rectal prolapse, no operation stands out in comparison to the others.” The authors do not seem to have received either ethics committee approval or consent from the patients. How should the editors proceed?

A paper reported a randomised controlled trial relating to a common investigational procedure. There are two different postural positions into which a patient may be put while the procedure is carried out, and individual operators may have a preference for one or the other, but both are in routine use.

A journal received an account by email from outside Britain of how 14 patients infected with a potentially lethal virus had been treated with an unusual non-pharmacological treatment. The treatment seemed bizarre, and furthermore, there was no mention of approval by an ethics committee or of informed consent. The author was twice emailed to ask if he had ethics committee approval and if he had obtained informed consent. There was no response.

A paper was submitted, describing surgery on the sexual organs of four women. The paper was poorly written and hard to follow, but it seems that this surgery was undertaken primarily because of the unsatisfactory sexual experiences of the women’s partners. There was no mention of ethics committee approval or of the women having given consent, not only for the surgery but also for taking part in an experiment. The paper came from overseas.

A manuscript was received from a group of authors who had not submitted to the journal in question before. The review was extremely critical and the paper was rejected. In a covering letter the reviewer said that not only was the experimental design flawed, but he was also convinced that the experiment described had never been done.