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2007

Case

Sponsorship, ethical approval and consent for study done as part of an expanded access program

07-32

We received a paper describing the results of an analysis of pathogen gene sequences from patients who had been given an investigational drug as treatment for their infection. The study had been done in Europe. One reviewer said that the paper did not explain whether the patients had been treated in the context of a trial or not and that no information about study sponsorship, ethical approval or patient consent had been included.

Case

Researchers give an experimental therapy to patients based on a laboratory study published in our journal

07-31

We published a paper in the journal which reported on microarray expression profiling of cell lines from a specific type of cancer (not named here, to preserve anonymity). That paper suggested that a particular compound might affect the function of a protein expressed in the cell lines; this compound could therefore be a possible candidate drug for use in this type of cancer, which might be explored further in clinical trials. (This compound currently has approved uses for other cancers.)

Case

Possible case of fraud

07-30

A paper was submitted to us describing an RCT carried out in a Far Eastern hospital. Soon after the manuscript had been sent out for review, one of the reviewers sent a letter alerting us to a “possible case of fraud”.

Case

An investigation into results that were “almost too good to be true”

07-29

A general medical journal received an RCT from a seldom-published, single-author, in an eastern European country. The results were striking, with an effect size that surpassed that of established medications for this condition, so the manuscript was sent for peer review. One reviewer commented that the results were “so highly statistically significant it is almost too good to be true.

Case

Attempt at dual publication

07-26

In October 2005, our journal commissioned a review on a specific topic from an expert in that field. The commission was accepted, and a submission date set. This was followed up and renegotiated several times over the coming months. A first draft was received in January 2007, and assessed inhouse for feedback to the authors. Some suggestions were made regarding structure and content, and the manuscript was officially submitted in August 2007.

Case

Inadvertent discovery of salami submission

07-28

The journal submitting this case to COPE sent a paper [paper 1] to a reviewer who wrote this in the review: “…That apart, this manuscript seems to be another report of the already published **** trial, looking at the data from a slightly different angle. I am not convinced, however, that the data is worthy of so many submissions.”

Case

Author dispute over internal report

07-27

Author A was paid to facilitate a meeting and write a meeting report for internal purposes.  He was paid to do this by author C’s company. The report was posted as a PDF on author C’s company website. No authors were listed on the report.

Case

The judgement of Solomon: a case of two strikingly similar papers

07-25

In February 2007, author A and a colleague submitted a paper (paper A) to our journal, which uses double-blinded peer review. We sent paper A for external review.

Case

Is ethics approval required?

07-24

The journal received a paper on an imaging technique which reported changes in a normal healthy volunteer. No adverse events were experienced. This study demonstrated the feasibility and safety of the imaging studies in a particular condition.

Case

A survey of doctors’ opinions, with no IRB approval or written consent

07-23

A doctor who trained in country A took the licensing examinations in country B because he wished to work in country B.

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