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COPE Members bring specific (anonymised) publication ethics issues to the COPE Forum for discussion and advice. The advice from the COPE Forum meetings is specific to the particular case under consideration and may not necessarily be applicable to similar cases either past or future. The advice is given by the Forum participants (COPE Council and COPE Members from across all regions and disciplines).

COPE Members may submit a case for consideration.

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Search results for 'retrospective'

Showing 1–20 of 33 results
  • Case

    Retrospective ethical approval?

    …ethics committee who would consider giving this retrospectively. A subsequent email from the chairman of the ethics committee to the journal expressed doubt about the value of retrospective approval, pointing out that when a study was reviewed prospectively it was possible to suggest changes to the protocol, which obviously could not be done when it was viewed retrospectively. The chairman added…
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    Ethical approval for retrospective study

    A paper reported the clinical outcomes of patients suffering from a neglected disease before and after a change in the national treatment policy which raised the threshold of one laboratory parameter before a more toxic, but more effective drug could be used. The authors did a retrospective cohort study of patients treated under both policies, to see how this change affected outcomes. They did…
  • Case

    Retrospective trial registration

    …consider such trials only if they were adequately registered before journal submission. The ICMJE journals will accept “retrospective registration” of trials that began before July 1, 2005 (retrospective meaning registration occurs after patient enrolment begins).…
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    Case Closed

    Seeking retrospective ethics approval

    I received a submission that had asked a series of questions of visitors to a website about a mental health issue. It was reviewed by a senior colleague and myself. While the science was fine we were both concerned that no mention had been made of any ethics approval. I raised this issue with the authors, especially given that deception was involved. The authors then appear to have sough…
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    Case Closed

    Retrospective registration, outcome switching and ethical approval

    Journal A received a number of concerns from a reader regarding a paper published in the journal. These concerns were reviewed and sent to the authors of a paper, along with additional comments from the editorial board. The concern was largely around retrospective registration, and an inconsistency between the trial registry record and the published paper. An editorial board member conducted…
  • Case

    Retrospective correction: how far back do we go?

    In 1990 a case report was published in which it was alleged that the use of a particular endotracheal tube had led to tracheal damage, requiring the child to have a tracheostomy and a tracheal reconstruction. This paper was from a specialist surgical unit, and a letter was subsequently received from the paediatricians who had cared for the baby at the referring hospital before and after the tra…
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    Case Closed

    Low risk study with no ethics committee approval

    …by a human research ethics committee. Question(s) for the COPE Forum• Would retrospective research ethics committee review be appropriate to consider in this situation?…
  • Case

    Ethical approval and fabrication of results

    retrospectively looked at some more patients to make the number up to 50. He said that he did not think retrospective case studies had to be approved by a review board. The webpage for the specialist research society cannot be located. Do retrospective case studies require ethical approval? Can we ask the authors for proof of ethics approval for their previous study of 15…
  • Case

    Suspected plagiarism

    …flow of the article and the subheadings and the text is too similar.It was pointed out to me by my associate editor.There have been no complains yet but does that mean one  should not investigate?Is the editor entitled to conduct investigations without complaints.Can plagiarism detection software be applied retrospectively?What action can be taken if only ideas are copied in the same sequence though…
  • Case
    On-going

    Ethics approval for survey design

    The Forum noted that most universities had a statement related to institutional review board (IRB) approval with respect to the COVID-19 pandemic, generally stating researchers could not conduct research that required approval and obtain retrospective approval on the research. In this case, it seems that the authors submitted an IRB application and performed the research, assuming the research…
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    Case Closed

    License for using a published scale

    …scale, she was contacted by a person claiming that he was representing the scale's developer and asked for a retrospective license and license fee, and threatened that if the she did not apply for a retrospective license and pay the license fee, she may need to take legal responsibility and retract the published paper. He also said that if she does not pay the fee, then the team’s lawyer would contact…
  • Case

    Is it unethical to reject unregistered (or late-registered) trials?

    We would like other editors’ opinions as to whether adhering to the journal’s policy on trial registration may contribute towards the non-publication of trial results (and thus bias in the literature). All of our journals have the same policy on trial registration—for studies started before July 2005, we permit retrospective registration (providing it was done before submission)…
  • Case

    CV study: was ethics approval and consent required?

    …Individual consent would not have been required. However, the collection of individual comments may well have met with a different response. It is likely that we would have requested that further information outlining the purpose of the study and details of potential dissemination would have been required. We are not in a position to give retrospective ethical approval for research. We felt…
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    Has formal ethical approval been granted that satisfies publication criteria?

    …on the proviso they will not be identified individually. This study appears to do exactly that, except that this is not a retrospective audit, this is an interventional study whereby these players have been subjected to a specific regimen. In my opinion, there are several issues here. (A) A blanket proforma that these players were asked to sign does not constitute formal ethics approval…
  • Case

    Ethics, institutional review and studies from private practice

    …the private clinic is not affiliated to a university and because the study was merely a retrospective chart review. The five authors on the paper are all affiliated with universities with ethics committees. We also noted that the owner/director of the private clinic is not listed as an author. We have also found that on the clinic’s website there is a reference to a “research study” regarding…
  • Case

    Randomised controlled trial without ethics committee approval

    …they thought that approval had been required, and if so, whether they would consider giving it retrospectively. The ethics committee chairman replied that the project certainly should have been submitted for ethics committee approval and that it was not possible to offer retrospective review or approval. He also added that had the committee considered it, they would probably not have been satisfied…
  • 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)…
  • Case

    Possible suppression of data

    This is a summary of a problematical research interaction between a pharmaceutical company and academic collaborators at a University involving a widely used drug. A pharmaceutical company appears to have exerted undue influence in an attempt to control the scientific literature. The research involved an important retrospective secondary endpoint in the three key…
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    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…
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    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…

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