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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.

Compromise of patient confidentiality?


A paper containing three case reports of the same disease was accepted for publication. The disease reported is fairly rare. The parents of one of the cases consented to publication on condition that their daughter was referred to in the paper by her first name rather than as a case number. This particular case has been discussed in the course of a national inquiry, but it is not clear whether the other two cases were discussed.


Ethical status of authors’ actions?


A consultant in public health and a consultant clinical biochemist employed by a health authority submitted a paper. It sought to address the question of benzodiazepine abuse and re-sale on the black market.


What happens when there is no local ethics committee?


A paper from Taiwan was reviewed and accepted for publication. However, one of the reviewers raised the question of ethics committee approval. When the editors checked with the authors, they responded that there is no ethics committee at their university and they were therefore not able to seek ethical approval. What is COPE’s view on this? The study was fairly straightforward involving a questionnaire, some simple lung function, skin, and blood tests.


A lost author and a new hypothesis


A paper was published in January 1998,and seven authors were credited. B was thanked for his contribution in the acknowledgements section. One year later B wrote to the editor, outlining two alleged incidents related to this paper. First, the cohort reported in the January 1998 paper was one that B had been working on since the early 1990s. In 1992–3 he sought collaboration with another research group. A grant was applied for and granted.


Retrospective ethical approval?


A paper reported a questionnaire study of patients’ views on their preferences between minimal access and open access surgery. The questionnaires had been given to patients attending two types of clinic. The paper made no mention of ethical approval and the author was asked to clarify. He responded that he had not obtained ethical approval but that he had spoken to the chairman of the hospital ethics committee who would consider giving this retrospectively.


Confidentiality and conflict of interest


A paper reporting an attitudinal study was sent for peer review. The editor received a letter from the reviewer stating that as he was personally acknowledged in the paper, he felt there was a conflict of interest and so unable to review the paper. The reviewer also pointed out that the research in question was part of a larger commissioned project with strict conditions of confidentiality.


Triplicate publication with possibly different data in each


A paper describing an outbreak of infectious disease was submitted to three journals. The submission to one journal described the index case; the submission to another included investigation and follow up of other cases and contacts in the country where the outbreak had occurred. The third paper looked at the spread of the disease into other countries.


Patients with vitiligo treated with anti-fungal drugs by a general practitioner


A letter was submitted for publication in which a general practitioner described how he treated patients with vitiligo “simultaneously with an anti-fungal and anti-bacterial medicament over a prolonged period.”He has done this because:“As is now known,a fungus resembles the human being genetically and there is a possibility that a fungus can hide in the melanocyte (analogically as is being done by the HIV virus) and therefore cannot easily be diagnosed by laboratory means.”The research seem


Unethical research


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.


Failing to get consent from an ethics committee


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.