A whistle blower contacted journal A regarding two published articles. The articles focus on the effect of energy healing on an in-vitromodel 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 the articles. The corresponding author responded with a clear explanation of how they implemented the study but concerns about how this would be reproduced by others persisted.
Consequently, a post-publication peer review was conducted. Unfortunately, the post-publication peer review provided no comment on the energy healing methodology that was implemented. The reviewer focused only on the methodological elements that gave no cause for concern, and summarised that the methods are suitable and valid.
Given this review, the editor who handled the manuscript feels that no editorial action is required. However, concerns surrounding the energy healing methodology and its reproducibility remain. It has been suggested that the reviewer is contacted again for an assessment of the specific energy healing techniques used in these studies.
Question(s) for the COPE Forum
If the reviewer or the handling editor determine that the methodology is sound but not reproducible, how should the journal proceed?
Advice:
A suggestion from the Forum was perhaps to ask at least one other post-publication peer reviewer to specifically comment on this particular issue.
This is an ongoing problem in this field. Some techniques that people use for healing touch and many other types of hands-on healing are difficult to standardise. People who work in this field and use this technology most likely understand this and so the problem is probably more for people who are uninitiated. A suggestion was that there needs to be commentary in the article by the author about the difficulties of reproducing the techniques if that was not sufficiently addressed in the discussion.
A discussion of the limitations of the study could be addressed in the journal, through the usual post publication discussion process or letters to the editor.
Another view was that in a scientific publication, if the method is not reproducible, then it is not considered science. Reproducibility is the foundation to science and so if it is not reproducible, should it be published? However, the post publication review suggested the methodology is sound.
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 well as patient written permission for publication. For all other cases concerning standard practise reports about practical treatment issues, only written informed consent from the patient is needed before publication. As expected, only successful practical treatment cases are submitted for publication to journal A.
The society related to the journal organizes a biannual complication meeting which is attended by a small audience of around 120 doctors at which participants present their complication cases. At this meeting, many basic complications are discussed, which can be related to lack of education, lack of knowledge of materials, lack of knowledge about patient disease, or insufficient training, some of which have devastating outcomes. Many of these complications are avoidable.
As an editor and a doctor, I would like to publish some of these cases to improve patient safety and healthcare in general. However, the authors are often afraid of legal repercussions and patients are often not willing to provide consent after bad experiences. My solution would be to publish a series of these case reports as one publication with all authors in alphabetic order. I would leave out specific patient demographics, such as age and gender, and I would do so without written patient informed consent.
Question(s) for the COPE Forum
Would this publication violate COPE guidelines? If yes, how could this be resolved?
Is there any other way to resolve these issues?
Advice:
The Forum agreed that the idea of presenting cases which do not result in improved patient safety or actual patient harm for learning opportunities is an interesting one and worthy of exploration. If any of the cases in this series have pending legal issues within an institution, this would be a significant consideration to protect the legal process. The editor must consider the legal environment in the country of origin, including regulations on informed consent.
As there are 120 cases, are there also 120 authors? If there are many authors, it may be easy to anonymise the cases, especially if the authors could be added in alphabetical order to help disguise identities. Otherwise, it is difficult to anonymise the data and retain essential elements for learning purposes. A suggestion was to publish one case per issue, deidentifying the data and to make all 120 presenters (or however many there are) the author(s). Another suggestion was to have a recurring column in a journal that has an ethics committee, who would review the cases and make necessary changes for protecting subjects’ identities. The journal could also seek institutional review of the cases to ensure that blinding was sufficient.
The Forum noted that changing the data is not acceptable unless that is clearly indicated in the text; if the case is a composite, this must also be stated. The reason being that researchers might be interested in doing composites of these cases, which would be based on false data unless the original cases are clearly labelled as composite or fictional scenarios.
The journal should consider that an investigative journalist may be able to uncover the actual identities, which might harm the journal, the authors and possibly the patients. If the authors are not able to anonymise the data, patient or family permission should be obtained, as well as legal advice. The editor may wish to consult the COPE guidelines “Journals’ Best Practices for ensuring consent for publishing medical case reports” https://publicationethics.org/resources/guidelines/journals%E2%80%99-bes...
If the editor wants to develop this project, he needs to have a strategic plan to publish these cases that considers the larger picture, and involves a sound, rational approach, which might be very valuable to readers. The Forum encouraged a careful review of the potential legal and privacy issues that must be addressed.
Peer review is the hallmark of scientific and scholarly publications. These authors explore 5 principles of good peer review and suggest ways for journals to use these to underpin best practices. https://onlinelibrary.wiley.com/doi/full/10.1002/leap.1222
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 contribution appeared in the published article.
Author A alleged he gave authorisation to present the case in a conference to author B who later published the article in our journal without his consent.
Question(s) for the COPE Forum
• Who is the owner of this article?
• Is this a case of plagiarism?
• What action can we take regarding authors A and B?
Advice:
The Forum advised referring the matter to the institution. Journal editors and publishers cannot be involved in adjudicating authorship disputes. Only the institution(s) can determine who is the rightful author. Hence the advice was to contact the institution and request an investigation. If the institution agrees to investigate, the editor may wish to issue an Expression of Concern until the results of the investigation are available.
As this was a case study, was permission granted from the patient to publish the paper? The editor could seek out the patient consent form, and determine if that came from author A or author B. Case reports must not be published without informed patient consent.
Following a 10 month inquiry, the UK House of Commons Science and Technology Committee has issued recommendations to strengthen requirements and improve compliance with the existing 2012 Concordat to Support Research Integrity [full report].
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, and additional experiments were required.
The editors followed-up with the whistleblower requesting more information and their identity. The whistleblower emailed back, concealing their identity, but provided additional information, highlighting a specific component of the research as unreliable.
Institution-2 (the one that was not claimed by the whistleblower) was informed of the whistleblower. Institution-2 responded by saying that the authors believed there was an initial problem with the data used, but these had been updated and were not fabricated. Institution-2, however, was not the institution that carried out the experiments in question.
The editors made the decision to obtain more information. On resubmission of the paper, the three original reviewers looked at the manuscript but were not told about the whistleblower. All three were satisfied with the changes made to the paper and approved publication. A fourth reviewer was asked to look at the paper and told about the anonymous whistleblower. This reviewer found no clear evidence of fraud, but he could not assess the experiments in question. This reviewer did, however, raise new concerns about technical deficiencies in the work. Aside from fraud, these new issues made it unsuitable for publication in the journal.
The editors requested outside assessment from researchers with knowledge of the work to redo the informatics analyses to see if the raw data (included with the paper) gave the same results as the processed data. Again, there was no clear evidence of fraud, but there was difficulty in complete reproducibility due to poor methods descriptions and lack of access to all of the data.
At this time the whistleblower sent an email recanting his/her original statement and saying they have assessed the work and the authors have made the appropriate changes to fix everything. This was an odd email as there had been no change in the manuscript since the resubmission.
The editors ultimately decided to reject the paper based on remaining concerns of misconduct and the heavy criticism of the fourth reviewer.
The authors from Institution-1 requested a meeting with the editors. At this meeting the authors: expressly denied misconduct; showed the editors pages of data from the experiments of concern; and provided the editor with a copy of an email from an anonymous whistleblower that the leader of the group had received 2 days before the journal editor had received their anonymous email. This anonymous individual claimed to be from Institution-1, and stated that one of the authors (from Institution-1) had visited their institution and removed data.
An additional oddity is that the email addresses from the whistleblower to the editor and to the authors were created to indicate they came from the institutions claimed. Investigation of the email origins showed that the two anonymous whistleblower emails came from the same individual, not two different individuals as claimed.
Question(s) for the COPE Forum
• How should editors act on a tip from an anonymous whistleblower, where there is uncertainty about the unknown person's goals and that, should institutions take punitive action without investigation of the whistleblower’s intent, careers could be heavily impacted.
• If the institutions, when informed, decide to take no action, do the editors have a responsibility to investigate to get a better sense of whether they should further push the institution given the authors can simply submit a paper elsewhere where those editors will not know about the potential for misconduct.
• Due to the importance for the career of individuals on this paper, can the editors aid the authors submitting elsewhere, given that the whistleblower lied, but there is no way to disprove fraud. Or should the editors provide the information about the whistleblower to the institution.
Advice:
This was a very complicated situation and the editors have no clear means to further investigate beyond what they have done already. The editors had gone far beyond what is normally assumed to be the role of the journal in such cases. The advice from the Forum was for the journal to contact the head of the institutions and the ethics board. The editor can use the Office for Research Integrity (ORI) website to check affiliations if the institutions are outside the US (there are some listings of cooperating national ethics approval boards). The Forum advised contacting the authors first before informing the institution. The institutions should also be informed of the whistleblower’s behaviour and the apparent falsification of email addresses to create the appearance of two whistleblowers.
Suggestions for another journal and assistance with revision might be appropriate in some cases. Because of the issues raised by review #4, the article was not suitable for this journal but there are other journals in the field that might accept a revised article. The suggestions for revision already provided to the authors will help them modify the article and correct any errors.
Follow up:
The editor informed the authors of the overall discussions at the COPE Forum, saying that they had done all they could based on COPE guidelines in terms of trying to assess the veracity of the claims (and detailed the standard COPE guidelines). The editor told the authors that he felt that at this point, further investigation into the situation had to move to their institution if they wanted to pursue that avenue and gain some resolution. Because of the serious nature of this issue, the journal told the authors that they had an additional referee look at the work, one who was very familiar with the journal. He/she raised additional concerns about the work from the standpoint of suitability to the journal, and hence the decision was made that the work was not suited to the journal.
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 full comparison of the trial registry entry with the paper.
The authors have admitted honest error with full explanations. The editor-in-chief has asked for confirmation that all authors and institution are aware and outlined options for next steps. The suggested options for next steps from the editor-in-chief are: (a) retraction of the paper; (b) substantial corrections and explicit declaration of the flaws of the trial procedures and protocol violations and selective and misleading reporting; which may well render the trial invalid or at least biased, and then providing a better and corrected summary table and narrative of what can be legitimately said. This is not ideal and will regrettably give the impression of insufficient rigour in the execution of a trial and the data still being in the public domain, although a more confident statement of a negative trial is better than selective reporting of some positive findings; (c) or we invite retrospective critique and commentary on trial and trials in general when reported to be invalid or flawed; this is an important educative role, but does not remedy that the trial data are in the public domain and are misleading.
Again, the authors offered an apology claiming honest error and preference for the article not to be retracted. They have offered to publish a correspondence letter to explain the registration issues in due course or correct any inconsistent sections according to the review comments and registry information. The journal is now questioning the next course of action: retraction, corrigendum and/or an editorial outlining the issue.
Question(s) for the COPE Forum
• The Editorial Board were initially considering retraction but are now considering publishing a narrative/editorial of the issues for transparency, confirming the journal’s current/new policy of requiring prospective registration and an explanation of any changes in protocol in the methods section. Should this accompany a corrigendum?
• Ethics approval: approved in April 2011, but the protocol states study execution time is August 2010 to July 2013. The authors state that the first patient was referred in May 2011. Does this need further explanation?
• Should the editorial board consider retraction?
• Are there any other actions the board should consider?
Advice:
The Forum asked if the journal had contacted the institution and if there was an investigation in progress. The editor informed the Forum that the journal has asked for confirmation that all of the authors and the institution are aware of the issues, but no response has been received to date. The authors have stated that the institution was not aware of the need for prospective registration. The editor may like to pursue the institution for more information.
The Forum suggested publishing an editorial note on the paper or, if the institution agrees to undertake an investigation, publishing an expression of concern. As there seems to be no institutional oversight, perhaps the editor should give the authors the benefit of the doubt. This could be an important educational opportunity, to educate the authors regarding trial registration; although now an international standard, many authors do not know about prospective registration. Hence a lengthy corrigendum and an editorial highlighting the issues would be appropriate.
The Council of Science Editors has a lengthy section on their website about correcting the literature with samples of actual corrections (https://www.councilscienceeditors.org/resource-library/editorial-policie...). In general, the correction options are errata, corrigenda, expressions of concern, and retractions, although some of the wording is nuanced in ways that might be helpful in this situation. The editorial note referenced above seems to fall under the category of an Editorial Expression of Concern. The National Library of Medicine has a fact sheet (https://www.nlm.nih.gov/pubs/factsheets/errata.html) detailing the types of corrections that can be linked to an article. This list includes “Comments” which could be used to link commentary from the authors as well as from editors.
Some journals ask for the full protocol to be submitted to the journal along with the article. The journal then checks the protocol against the paper before the paper is peer-reviewed. The authors are asked to explain any deviations from the protocol. The editor may wish to consider this approach to avoid similar situations in the future.
Follow up:
The Senior Editorial Committee reviewed the advice from the COPE Forum and agreed with the suggested actions. The authors have drafted a Corrigendum, and this is currently undergoing review and revision by a board member with expertise in the field. Members of the editorial board are currently drafting an editorial for publication alongside the Corrigendum. An Expression of Concern will be published shortly to alert authors while the Corrigendum and editorial are drafted.
Resolution:
Case Closed
Advice on follow up:
Follow-up (May 2019)
The authors requested changes to the corrigendum which could not be accommodated. On this basis the Senior Editorial Committee decided to retract the paper. The retraction notice and editorial have been drafted and will be published online shortly.
Authors Steve Yentis (former COPE Council member and Editor-in-Chief, Anaesthesia) and COPE Council Version 1 March 2015 How to cite this
Yentis S on behalf of COPE Council. Sharing of information among editors-in-chief regarding possible misconduct. Version 1. March 2015 https://doi.org/10.24318/cope.2019.1.7
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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 review was not required.
Using the reference number cited in the article, the reader obtained the relevant documents from the research ethics committee via a freedom of information request. The reader argued that the documents from the ethics committee related to data that predated what was presented in the article. A review of the documents indicated that this appeared to be the case. In addition, the reader argued that service evaluations should not be presented as research articles as these are two separate things.
The editor of the journal wrote to the author of the article and asked for comment on the issues raised. The author replied that there had been regular contact with the ethics committee as the service period of the clinic was extended, and the ethics committee continued to indicate that the data were being collected as part of a service evaluation and further ethical review was not required. In addition, the data were collected anonymously, which would further exempt the study from requiring formal ethical approval. The ethics committee also provided the authors with a letter indicating that “this letter …may be provided to a journal or other body as evidence that ethical approval is not required under [the regional] research governance arrangements”.
The author indicated that similar requests had been made in the past and that, due to the controversial area of the work, many attempts were being made to retract articles that used the data from the clinic. Attempting to prevent further queries, the author asked the institutional head of research to post a public statement indicating that the work was conducted appropriately and met the highest ethical standards. As requested, the head of research issued a statement on the institutional website in support of the work.
The editor then responded to the reader indicating that the journal was satisfied with the author’s response and the support of the head of research. The reader was not satisfied with the editor’s response and forwarded the details of the case to a high profile blogger who writes extensively on this controversial area of medicine. The blogger then posted a blog criticising both the article and the journal’s handling of the case. The blog was shared widely on social media. From the journal’s perspective, the blog was inaccurate, misrepresentative and damaging to the publisher’s reputation.
Question(s) for the COPE Forum • Should we allow data collected in service evaluations to be published as research articles? In medical journals, this is often seen as an acceptable exception; however, if research ethics committees are declaring a study "not research", should journals do the same? • Should the journal have posted a correction on the article to provide a more detailed ethics statement, bearing in mind that anything labelled a "correction" in a controversial area would be misinterpreted as an error in the research by the critics? • How should journals respond to blog posts that they feel portray them unfairly and are damaging to the publisher's reputation?
Advice:
The Forum suggested that perhaps the issue is not whether or not the service evaluation is research, but was the evaluation carried out in human subjects (which would require a sound ethics approach) or were the data contained in registries where the patient data were anonymised. It would appear that the latter is the case and that this is a secondary data analysis, but the editor could ask for clarification from the author on the methodology as it needs to be adequately described. Was this a dataset developed out of a research project that had ethics approval for human subjects? If so, the secondary analysis might not need new ethics approval if additional analyses were covered in the initial approval. The methodology is confusing the issue of whether ethics approval was required. The Forum suggested these points need to be clarified before a decision on whether to add a correction on the article or to respond to the blogger.
This issue often arises with audit articles, which is often a term used for service evaluations. There is a contradiction in that journals publish research articles and yet audits or service evaluations are not thought of as research requiring ethics approval. However, it is up to the ethics committees and their procedures to decide what is research for the purposes of ethics approval. Separately, journals need to decide what they can publish so it is the editor’s decision on what to publish in their journal, irrespective of the decision of the ethics committee.
The Forum suggested that the journal may need to provide more information or specific guidelines for authors on what they mean when they say they accept waiving of ethics approval for service evaluations. What is meant by service evaluations?
The Forum agreed that posting a correction may be excessive and perhaps a short editor’s note would be more appropriate. The Forum advised against responding to the blogger and getting into a spiral of communication that could become problematic. A suggestion was to write an editorial on the concepts more broadly and how the journal’s policy is going to evolve in the future regarding secondary research being conducted as service evaluations/audits/quality improvement reporting and what the ethics requirements will be in the future. What are the expectations of the journal for future submissions of service evaluations?
The Forum suggested the editor may wish to consult the SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence) guidelines on how to publish quality improvement studies, which can be found on the Equator Network website (https://www.equator-network.org/reporting-guidelines/squire/).
Follow up:
The journal chose not to respond to the blogger and considers the case closed.