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 subjects’ protection information was provided. This is not unusual at the journal when the institutional review board (IRB) or organisation does not provide documents in English. The journal requires an English language translation copy of IRB approval on submission of the revision. After peer review, a revision was requested along with an English translation of the IRB approval letter, the exemption or the organisational policy or government regulation that clearly exempted the research protocol from ethics review.
The revised submission included an English translation of portions of the IRB approval that documented there were two review dates; both occurred after the initial manuscript was submitted to the journal and the initial “revise” decision was sent to the author. It is unclear if the IRB requested revisions to the protocol, which had already been completed, before approving. The editor rejected the manuscript at this point for ethical concerns.
The corresponding author requested an appeal of the editor’s reject decision. The corresponding author reported a different starting date for data collection than the original manuscript had listed, now only two weeks prior to initial manuscript submission. The corresponding author said that they had missed the IRB deadline in month 2, were triaged and not considered for review by the IRB due to the COVID-19 pandemic at the usual deadline for month 3, but were able to submit on the last day of month 3 and received approval in the middle of month 4 (after which the revised manuscript was submitted). The corresponding author acknowledged they chose to collect data prior to IRB submission and approval under the pandemic circumstances, with a self-determination they were following the requirements of the Helsinki Declaration and no other documented ethical or human subjects’ review prior to data collection was apparent.
The journal often receives manuscripts of survey results intended for an internal organisation needs assessment or evaluation, or for quality approval purposes. There are instances where the results of such survey analysis are appropriate to publish and exempt from IRB review, or for the authorship team to seek IRB approval for dissemination after data collection if an unexpected or novel relationship is found. However, in this instance, there is no clear documentation of the intent for a specific organisation’s needs assessment, evaluation, or quality improvement that would clearly meet exempt from review or ethical approval criteria.
Question(s) for the COPE Forum
Should the journal allow resubmission of the manuscript or an appeal to the reject decision, under the unique circumstances of the COVID-19 pandemic, which included the IRB triage of the corresponding author’s protocol.
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 would be approved. But most universities require researchers to wait for that approval—there is no right of retrospective approval. The Forum believed that the journal took the correct decision in rejecting the article and should not seriously consider an appeal. However, a suggestion was to consider contacting the original IRB to ask if they had a policy about retrospective data collection and if they were aware that the data collection had already occurred.
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 is a high potential for publication once the data are gathered and analysed. There are no patient data involved or publicised.
Question(s) for the COPE Forum
What is the policy on institutional review board approval for social media surveys or research?
The Forum agreed that institutional review board (IRB) approval is required for social media surveys or research. The Forum suggested that if the authors are associated with an institution, they should be using the institutional IRB for approval of the research. If researchers are gathering data about people, and social media is just a means of collecting the data, then some form of ethical oversight is needed.
The editor told the Forum that the response from the institution was that because the study did not involve an intervention on a patient, they were not responsible for oversight of the study. The Forum noted that often IRBs are only interested in interventional research, and they will not consider survey, qualitative or quality improvement research as part of their remit. In the USA, the American Association for Public Opinion Research has information on standards, ethics and suggested IRB forms. But ultimately, it is the university's responsibility to approve the research.
Surveys might be asking questions about people’s health, sexual orientation or criminality, for example, and the survey could involve vulnerable groups. An IRB would be concerned about these aspects and so the survey would clearly require ethical review in these circumstances. Most universities have a distinction in terms of light touch versus heavy touch institutional review, where the IRB might review the research questions, who the researchers are talking to, is private information being requested, are the individuals identifiable? Interacting with people online could also be considered an intervention and hence ethical approval would be required.
The authors ultimately decided to file for institutional review board approval at their institution and this was granted for the social media survey.
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?
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?
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.
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?
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.
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.
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.