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Questionable/unethical research

Case

Ethics committee approval

15-07

We routinely ask for ethics committee approval from every research manuscript submitted to our journal. Sometimes, studies from different countries may not have ethics committee approval and authors may claim that their study does not need approval. In such situations, we consult COPE’s “Guidance for Editors: Research, Audit and Service Evaluations” document and evaluate the study at the editorial board and decide whether or not it needs approval.

Case

The ethics of self-experimentation

15-03

The author was the subject of his study. He depleted himself of a vital nutrient until he had overt clinical and biochemical signs of the deficiency. He monitored various biochemical parameters as he became more deficient and submitted two manuscripts presenting his results: one detailing the biochemical changes and one detailing the differences in results obtained from different commercially available assays for the nutrient.

Case

Institutional review board approval required?

14-09

We have a query regarding institutional review board (IRB) approval for a paper in production.

The paper reports on a 2 year follow-up and cost-effectiveness evaluation for a treatment programme. A previously published paper reports on the original evaluation of the treatment programme. The authors have not obtained IRB approval for either body of research.

Case

Institutional review board approval needed?

14-08

A graduate student submitted a paper to a journal and noted that in her country, unless the research is directly medical, institutional review board (IRB) approval is not required or completed. The journal has a policy of requiring IRB approval on any human subjects’ research. This study was looking at practitioners and their work with students having a particular diagnosis.

Case

Fraud or sloppiness in a submitted manuscript

14-05

In June 2014 we received a manuscript by four authors from a well known research institution. They described a randomized trial comparing a variation in a procedure with standard care. In total, 200 patients were randomized, 100 to each arm. As measured by an interview, patients undergoing the new procedure were statistically significantly more content than those in the control arm.

Case

Ethical concerns about a study involving human subjects

13-14

A manuscript was submitted to our journal describing a study of a new drug. The manuscript had only one author who gave their affiliation as a company that we can find no record of online. It describes a study in which they appear to have developed a new drug, carried out a toxicology study in mice and then, because no adverse effects were seen, tested it on one patient and five healthy volunteers. There appear to have be no stages in between.

Case

Findings of a published trial called into question by a subsequent audit of trial conduct

13-04

In 2008, our journal published a phase 2 randomised controlled trial of a new medicine. In 2011, the regulatory authority in the country where the study was performed decided to undertake routine monitoring of completed studies and this trial was selected for random inspection. The author informed the journal of the inspection and provided a translation of the report (independently verified as accurate by our journal).

Case

Ethical concerns and the validity of documentation supplied by the authors

13-03

We became concerned that not all of the co-authors were aware of a research paper submitted to our journal due to the difficulty receiving responses from the email addresses that had been supplied and their nature, given that the authors all worked in a hospital/academic institution. Despite repeated requests and attempts we remained dissatisfied with the responses and did not feel certain that all of the authors were aware of the paper.

Case

Inadequate assurance of human research ethics for a questionnaire

12-33

A questionnaire was distributed to knowledge workers in an organisation to investigate the following hypotheses:

— H1.There is a positive and significant relationship between ethics and organizational performance.
— H2. There is a positive and significant relationship between ethics and intellectual capital.
— H3. There is a positive and significant relationship between intellectual capital and organizational performance.

Case

Fraudulent data presented in a manuscript

12-29

Author A submitted a trial comparing the safety and feasibility of two delivery techniques in patients. The trial, which was done at author A’s institution, was assessed by inhouse editors, who decided to send it out for peer review.

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