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Service evaluation as research in a controversial area of medicine
We received an email from a reader relating to the ethics statement in a research article published in 2011. The article presented data collected at a clinic relating to a controversial area in medicine. The ethics statement in the article indicates that, in accordance with regional guidelines, the research ethics committee deemed that the study was a service evaluation and formal ethical revie… - CaseOn-going
Authorship dispute and possible unreported protocol amendment
Our journal accepted a randomised controlled trial for publication which has not yet been published online. In the submitted paper, the randomised controlled trial is described as commencing in 2004 with completion in 2011. We have received an email and telephone call from an individual not listed as an author or reviewer of the paper with the following alleged disputes:• He was an invest… - CaseCase Closed
Parental consent for participants
As editor of a psychology journal, I received a manuscript from a group of scholars. The authors describe a qualitative online study with adolescent girls, aged 15–18 years, who met in person with a stranger they first ‘met’ online. The girls describe their reasoning about the risks, the safety measures they used and reactions to discomfort they experienced in the meetings. The authors n… - CaseCase Closed
Low risk study with no ethics committee approval
A manuscript was submitted to our journal that describes a social media advocacy campaign that was run by an international NGO for the purpose of eliciting public support for a new law in a low-middle income country. The authors are from the NGO and the government department in that country, that together funded and ran the campaign, and also collected and analysed the data used in the manuscri… - CaseCase Closed
Data anonymity
A paper was submitted to our journal. The managing editor was concerned about patient information in the paper and queried the authors. The authors responded that the data were collected from routine samples and so consent was never obtained. The patients were lost to follow-up, and there was no ethics committee approval as it involved the study of existing data, but they did discuss with the i… - CaseCase Closed
Ethics committee approval
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 editor… - CaseCase Closed
The ethics of self-experimentation
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 a… - CaseCase Closed
Institutional review board approval required?
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. The initial research wa… - CaseCase Closed
Institutional review board approval needed?
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. The editor r… - CaseOn-going
Fraud or sloppiness in a submitted manuscript
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. This manusc… - CaseOn-going
Ethical concerns about a study involving human subjects
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 volunte… - CaseCase Closed
Findings of a published trial called into question by a subsequent audit of trial conduct
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… - CaseOn-going
Ethical concerns and the validity of documentation supplied by the authors
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… - CaseCase Closed
Inadequate assurance of human research ethics for a questionnaire
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 intelle… - CaseCase Closed
Fraudulent data presented in a manuscript
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. During the peer review process, some reviewers pointed out that “this work seems premature, experimental and hard to believe”, and also expressed suspicion… - CaseOn-going
Possible violation of the Helsinki Declaration on Scientific Research with Humans
A manuscript underwent peer review and the resulting reviewer comments raised grave concerns about the ethical legitimacy of the study.The reviewer: questioned the authors’ impartiality, suggesting that there was an undeclared conflict of interest; raised serious concerns about the extent to which participants gave informed consent; strongly doubted that the… - CaseOn-going
Unethical private practice
This single author manuscript describes the treatment of 300 women with psychological problems. The women were randomised to either therapy or pharmacological intervention, and this study reports the relative effectiveness of these strategies. At submission, the manuscript did not contain any mention of ethics approval, consent or trial registration. When the author was queried on these… - CaseOn-going
Authorship dispute
A manuscript was published by journal X and submitted by author A (last author). Author B claims that fraud occurred in relation to authorship for the following reasons. (1) Author A did not take part in producing the data for the paper and has never been a co-author on any version of the manuscript.(2) A paper with very similar content ,which was part of the PhD thesis of author C… - CaseCase Closed
Was this study unethical?
We reviewed and published a randomised controlled trial in which children’s exposure to parental secondhand smoke (SHS) was either sustained (usual practice control) or parents were asked to avoid smoking around their children (intervention group). The study included more than 400 children averaging 9 years old. Parents provided written informed consent. The study was approved by the ethics com… - CaseCase Closed
Request to withdraw as an author of an accepted but unpublished paper
Last March we accepted a paper written by a post-doctoral fellow (PD) and an assistant professor (AP). The work was done by PD in AP's laboratory; PD has now moved on (to another country, in fact). Soon after the manuscript was sent to production, AP sent an email asking to delay production of the manuscript because AP was worried that there may be an ‘error’ in the manuscript that might requir…