Protection of subject (human)

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

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.

Case

Unethical research

98-10

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Subjects were withdrawn from the study if their duodenal ulcer relapsed.

Case

A commentary on a piece of (unethical) research

97-09

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.

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