- CaseCase Closed
Withdrawal of acceptance based on potentially unconsented data
Two papers were retracted (without dispute from the authors) after a lengthy investigation. It was discovered that some of the data used in these articles were gathered without participant consent for the study or for publication (no participants are identifiable). The investigation was conducted by a public body in the country of the authors, and the journal has been told that they will not be… - 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, g… - CaseOn-going
An unpublished PhD thesis included in an institutional library is submitted to an academic journal
A manuscript was submitted to Journal A. A routine CrossCheck report revealed a 70% match to the author's PhD thesis. The journal recommended that the author expand the article with new content. The author raised an objection, arguing that the PhD thesis is not published in a journal, but is only included in the institutional library. The journal noted that related issues had been… - CaseOn-going
Ethical conduct of qualitative research studies
Publishers are seeing an increase in submitted data generated from qualitative research studies. These studies are answering important questions such as identifying unmet need or highlighting the lived experience, potentially adding real value to the body of evidence especially in rare diseases. They are often Pharma funded and / or patient advocacy group led. Many of these studies have… - CaseCase Closed
Reader concerns about ethics approval and consent from a vulnerable population
A reader raised concerns on social media about whether informed consent for research reported in a published article was obtained. An investigation by the journal resulted in the publication of a correction explaining that written, informed consent was obtained from the research participants. A separate, small group of researchers followed up and raised further questions regarding… - CaseCase Closed
Request to remove author from submitted manuscript due to academic misconduct
Regarding a submitted (but not yet accepted) paper from a scientific collaboration, one of the authors has asked whether an instance of academic misconduct or - for that matter - any non-scientific but rather unsavoury personal facts or accusations (e.g. a penal or civil proceedings) can be considered as a valid ground for requesting that the journal remove an author from the paper, as per the… - CaseCase Closed
Data availability for vulnerable populations
A paper on a vulnerable population was published in a journal. The journal followed their usual procedures for processing papers on vulnerable populations, by requesting and reviewing further information on the ethics approval and consent procedures of the study (e.g.: recruitment procedures; blank version of the consent document participants read and signed; the study protocol that was approve… - CaseOn-going
Dealing with cases with culturally offensive content
Society journal X and propriety journal Y have received complaints regarding historic papers published in their journals (generating a lot of anger on twitter). The papers outline a practise the society (who had a historic role in its development) no longer endorse. The society has released an apology about their involvement with the practise, but the practice itself is not illegal (in the majo… - CaseCase Closed
Where should journals escalate serious concerns about an institution or institutional review board?
A publisher received a submission to one of their journals that raised ethical concerns. The concerns were related to potential harm or undue risk for participants who may be vulnerable. The publisher reviewed the ethics approval statement, and the authors had met the journal’s policy requirements by prospectively obtaining ethics approval from their institution before beginning the rese… - CaseOn-going
Ethics approval and consent
A complainant raised six articles to the attention of the editor-in-chief, with concerns about ethical approval and possible conflicts of interest regarding the way that approval was granted. The studies all involved minority populations. Ethics approval had been granted by the institutions for all of the manuscripts involved, along with written informed consent and corresponding ethics… - CaseOn-going
Ethics approval for survey design
A manuscript was submitted to disseminate a cross correlational survey research study. The manuscript states that the data were collected through surveys for the two calendar months prior to initial manuscript submission, which occurred in the middle of the third month. The initial submission indicated the research followed the principles of the Declaration of Helsinki, but no other human subje… - CaseCase Closed
Is approval needed for a social media survey?
An author has contacted the journal enquiring about the need for institutional review board approval for a survey. The survey is not derived from a specific institution but rather out of the personal interest of the author(s) who are targeting a point of wide scientific interest. The authors have a broad reach in social media. The topic is of significant interest to the field, and there… - CaseCase Closed
Appropriate scope of review for retractions
An institutional review recommended retraction of certain works by a highly prolific and influential author who has since died. The institutional review focused on a relatively small portion of this author’s work. The institution recommended retraction based on deeming the articles unsafe and identifying several concerns, including that the articles' conclusions were implausible. As a pu… - CaseOn-going
Reproducibility of methodology
A whistle blower contacted journal A regarding two published articles. The articles focus on the effect of energy healing on an in-vitro model of disease. The whistle blower raised concerns about the appropriateness and reproducibility of the energy healing methodology used. The authors were contacted to provide an explanation of the methodology as there was a lack of clarity in… - Case
Publishing complications and patient safety
Journal A is dedicated to communication about practical treatments related directly to patient and personal experiences. These ongoing discussions have been part of this specific medical profession for the past 50 years and journal A is a platform for these discussions. Regarding new treatments and new developments, permission from the local medical ethical commission is mandatory as wel… - CaseOn-going
Authorship issue related to misleading action of one author
Our journal received a manuscript which was a report of an evaluation and enhancement of an online clinical decision support system (CDS) for a specific population at risk of a disease. The online CDS had been developed by a national agency with a mission to support health promotion and disease prevention activities. Evaluation of the CDS was supported through contracts and sub-contracts. The f… - CaseCase Closed
Authorship conflict
Author A contacted our journal following publication of a manuscript claiming that he was the rightful author. We asked the author for proof and he said that he had all of the data concerning the patient because he received the operative specimen and made the diagnosis. Author A said he also collaborated in writing the article with author B and hence was surprised that neither his name nor his… - CaseCase Closed
Scientific misconduct claim from a whistleblower where the institution will not investigate
A journal received an allegation of scientific misconduct from an anonymous individual stating they were from the group that had written the paper (Institution-1, there are two institutions involved in this research). The email stated that the scientific bases of the article were unreliable. The paper was currently with the authors who were revising the paper after the first round of review, an… - CaseCase 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 a… - CaseCase Closed
Ethics of non-active management of a control group
An article was submitted involving over 200 pregnant patients with a systemic illness (from 2010 to 2015) who were recruited and assigned to a control group or an active intervention group (of their systemic illness). The control group received routine antenatal care while the intervention group had active surveillance and management of their systemic illness during the pregnancy. There…