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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

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Subjects were withdrawn from the study if their duodenal ulcer relapsed.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

Failing to get consent from an ethics committee

98-05

This case was described to me by an author who is about to submit a paper. He has discovered that a member of his team has produced a lot of fraudulent data for other studies, and has forged consent from ethics committees. This researcher has been reported to the GMC and his case is pending. The problem with the paper about to be submitted to us is that the fraudulent researcher falsely claimed that he had gained consent from three ethics committees for patients to be x-rayed.

Case

Unethical research undertaken by a single handed GP

98-03

We have received a paper from a GP testing the hypotheses that because 24,25 cholecalciferol has a similar structure to commercially available statins, it may act as an inhibitor of HMA co-reductase. He screened 350 patients in his practice and identified 77 who had a cholesterol concentration above 6.5 mmol per litre. Thirty-three of them agreed to return for a second test 2 weeks later.

Case

Not getting consent from an ethics committee

97-17

We had provisionally accepted a randomised controlled trial of an exclusion diet given to young children with a particular condition. The trial design was that one group started the exclusion diet a month before the second group. In other words, both were given the “treatment.” One part of the trial was that children who were thought to have an allergy to a particular food were rechallenged with that food.

Case

Informed consent

97-10

A group of researchers are conducting a study of whether women aged 65 to 69 years will accept screening for breast cancer. They plan to invite these women for screening in the same way as they invite younger women for screening but will not know that they are part of a research study. The authors want advice on whether journals would be willing to publish their results, despite the fact that the women will not have given informed consent to be part of the study.

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.

Case

False memory syndrome

97-07

A doctor has submitted an account of how his daughter falsely accused him of having abused her as a child. His daughter is another British doctor. We would like to publish the account as part of a package of articles on false memory syndrome. The questions we are considering are: (1) Can it ever be right to publish something that describes the intimacies of a family conflict, to illustrate a subject?

Case

Living unrelated (commercial) organ transplant

97-04

A paper submitted for publication describes a series of children with renal failure who had had kidneys transplanted from commercially acquired donors. The authors of the paper had not carried out the transplants. Indeed, they had been carried out in another country. The authors simply reported what happened to the patients after they returned. The paper, while not of high priority for publication, is acceptable from the scientific point of view. Can it be accepted on ethical grounds?

Case

Should we have had author consent for a randomised controlled trial of a peer review?

97-02

A medical journal conducted a randomised controlled trial of papers submitted to it without getting consent from the authors concerned. An author found out and objected. Should the journal have sought consent from its authors?

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