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Unusual consent process in a vulnerable population


A clinical trial was conducted in a low income country. The trial involved two schools. At the first school (the control school), children would receive a one-off drug treatment for a common infection (such “mass drug administration” is the norm for treating and breaking the transmission cycle of this infection). At the second school, children would receive the same one-off drug treatment plus a long term oral nutritional supplement.


Author trap/fabrication detection


This is how I dealt with an author who submitted a fabricated manuscript to my journal.


Controversy regarding ownership of a device


A paper was submitted which described the outcomes of a clinical trial evaluating a particular device. The device was claimed to represent a placebo version of an active device intervention. The paper was reviewed fairly critically and one reviewer pointed out that from the reference list it did not seem that the authors had developed this type of placebo device, while the title of their paper suggested that they had.


Non-compliance of author with request for information


In April 2007, an original scientific article was published on line (ahead of print—it is now published in print, September 2007). In July 2007, the editors received the following request from a scientist who read this article: "Since I am interested in this subject and I already work with it, I need to know some technical information from the authors. I have called the group five times and wrote them several emails, but unfortunately there was no response.


Signing on behalf of other authors


The editors received a manuscript from a Far Eastern country ready to accept. The senior author (who has spent a lot of time in the West) was in the US when the editors asked for final signatures to be sent.  The senior author instructed his team to collect and fax signatures while he was away and this was sent to the editors.


An appropriate response to concerns of research validity


A paper describing a novel technique was submitted. Three out of four external reviewers felt that the results could not be true. The manufacturers of the tool used in the technique provided evidence to support the reviewers’ claims that the results were not feasible.

The editor wrote to the authors asking them to explain their results. The authors replied saying that they were unable to replicate their initial results and wished to withdraw their manuscript.


HIV testing without offering treatment to affected individuals


A team of Western researchers carried out a longitudinal study of pregnant nomadic tribeswomen in Africa between 2002 and 2003. They took blood samples during and after pregnancy to test for a specific disease. Those who tested positive were treated. An attempt was also made to trace contacts, and the women’s status was rechecked after pregnancy to ensure effective treatment. 


Studies where there is no research ethics committee, or where committees disagree as to the need for approval


The editor of this journal, in common with other journals, requires that, where appropriate, studies published should have been approved by the relevant ethics committee. In some cases researchers have reported to the editor that they have found no committee willing to accept competence, or that different committees are taking different lines on which studies require approval.


Effect of the British Human Tissue Acts on biological monitoring


Biological monitoring is a common procedure in assessing the dose of contaminants from a workplace atmosphere.  It may include measuring a contaminant, such as lead in blood, or a resulting metabolic product, such as mandelic acid in urine following styrene exposure.


Confidentiality and privacy issue


A manuscript was submitted from UK authors. The study was a case series of infants with a particular condition. A table in the manuscript contains descriptive data which are critically important for the readers with respect to understanding the risk of this condition in young infants and the likelihood of abuse.