- Case
Unusual consent process in a vulnerable population
…author of the paper. The letter stated that he has been in contact with the IRB and the IRB has now granted retrospective approval for the consent that was used in the trial (ie, asking one PTA representative at each school to consent on behalf of all the parents). The senior author wrote to the journal asking if we would now reconsider the paper. The editors gave a firm no, saying that (a) such… - Case
No ethics approval or informed consent?
The committee were in agreement that the editorial team had a moral responsibility to take further action as there is a possibility that patients may be put at risk. The advice was that the editor should write to the ethics committee and/or the medical board to determine if approval had been obtained and whether it was obtained retrospectively. The editor should write to all of the authors… - Case
Potentially unethical publication
The committee discussed whether or not this was a retrospective cohort study without informed consent or ethics committee approval. The committee felt that this could also be an example of good clinical practice by the author in that having read about the potential for adverse effects of treatment X in patients with specific risk factors, he/she called back those patients at risk for a check… - Case
Plagiarism and possible fraud
…retrospectively, and a letter from the ethics committee was sent to the editors. When the editors attempted to contact this committee they were passed onto another ethics committee in a different area. The letter was sent to the author’s institution head. Unsigned letters and emails, purporting to be from the co-authors’ head of institution, were sent to the journal, and the author supplied an Excel spreadsheet… - CaseCase Closed
Institutional review board approval required?
The authors elected to ask a private institutional review board (IRB) to review the study, and the private IRB verified that the study was exempt (retrospective, de-identified data). We obtained a copy of the IRB’s decision and published the paper with an explanation of the exemption.… - Case
Potential case of plagiarism
One of the referees of our journal has brought to our attention a potential case of plagiarism. The referee feels that the a manuscript submitted to our journal, representing a retrospective study of a cohort of patients with a particular condition, plagiarises an article published in another journal in 2003. The authors are from an institute in a middle-eastern country. The… - Case
Attempt at dual publication
…had been made at any stage. A retrospective check showed that the first draft had been even more similar to the published version. Both authors were contacted to explain: - why a near-identical manuscript had been submitted; - how this situation had happened, given the timeline and date of original commission. In reply, the authors stated that the… - Case
Ethical approval for a study
…a problem that ethical approval had not been gained (apparently, because the intervention was not a “medical” one). We replied that they should have registered the trial (and could do so retrospectively) in line with new WHO policies on all interventional studies and that the Helsinki Declaration would require ethical approval for research which examines the effects of an experimental procedure on… - CaseCase Closed
Author displays bullying behaviour towards handling editor
…requested formally by a lawyer. The Forum suggested that in retrospect, perhaps the journal should have involved the other co-authors, given that it was the corresponding author who made the threats. It is possible the co-authors may not have been aware of the corresponding author’s threats. Also, with the benefit of hindsight, it is possible that after the author had done the social media… - CaseCase Closed
Ethics committee approval
…editorial board and decide whether or not it needs approval. However, as an editor, what should I do in the following situation? Any research, be it a retrospective analysis of routine patient data, an in vitro study or a study on bacteria requires institutional ethics committee approval in country A. In country B, ethics committee approval is not required for such studies (this information is… - CaseCase Closed
No ethics committee approval of a study
The Forum agreed that the described project was clearly research and not a service audit. It appeared, in fact, to be a prospective randomised trial and so it should have been registered and ethics approval obtained. Retrospective approval would not be appropriate. In addition, all participants should have given their informed consent. The lack of consent suggests a breach of the Helsinki… - CaseCase Closed
Post-publication correction because of lack of consent
…them with a 'formal reprimand', although no further action was taken. The journal will almost certainly have to redact at least part of the article (in addition to issuing a retraction notice) in the interests of protecting the identity of the participants. It is not possible to retrospectively anonymise the information. Question for COPE Council What are… - CaseOn-going
Ethical concerns and the validity of documentation supplied by the authors
…committee clearance has since been granted retrospectively after the paper was submitted. As a result we have significant concerns about this paper, its ethical clearance and some of the documentation that has been supplied. We have advised the authors that we have suspended processing of their paper and that we would seek further advice from COPE. Our intention is to report our concerns to the… - CaseCase Closed
Author requests permission to publish review comments
…retrospectively change what was in place when this paper was reviewed. Hence the Forum agreed that the journal has done all it can and no further action is needed here. A suggestion was to review the journal’s instructions to authors and instructions to reviewers to ensure the guidance regarding publishing reviews is very clear. The Forum discussed the wider issue of who owns the peer reviews. Copyright… - Case
The ethics of drug/medication use evaluation audit cycles and publication of the results
…baseline audit, obtain consent from the patient for inclusion (‘if required by local authorities’), conduct a brief postoperative patient interview regarding pain management and, after discharge, retrospectively collect pain management data from the medical record . Data were submitted to the national project team for collation and assessment, with individual and combined results fed back to… - CaseOn-going
Ethical approval requirements for case study reports
We have noticed a lot of variety in the way that ethical approval for Case Reports are published in different journals. For example, some state that the study was determined not to require Ethics Committee (EC) or Institutional Review Board (IRB) review especially if it was a retrospective review. Others state that all procedures were carried out in accordance with approved ethical standards,… - Case
The judgement of Solomon: a case of two strikingly similar papers
…themselves. One viewpoint was that, in retrospect, the editor should perhaps have allowed the papers to follow the usual editorial procedures, without interference, and should not have shared the information with the authors. Some argued that paper A should be published first as it was submitted first, but others suggested that from the reader’s point of view it would be more interesting for the two papers… - CaseCase Closed
Multiple complainants for a single article
…author has agreed to make the complaints public and give a reply in public. Can we conclude the case based on our current investigation results or shall we contact the ethical committee for further investigation? In retrospect, do we need to ask the author to give a point-to-point reply to the complaints from each complainant? The author was willing to cooperate at first but lost… - CaseCase Closed
Serial plagiarism by an experienced author
…editors of other journals in the field. We have also retrospectively checked the overlap of all submissions currently in process and identified several others with unacceptably high similarity indexes. We are asking those authors to withdraw their submissions or to revise them to eliminate the overlap. Of the 231 submissions that have been checked to date, 71% have an iThenticate…
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