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 (https://www.aapor.org/) 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.
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 publisher, we are moving forward with reviewing potential retraction of the articles identified by the institutional report. We are questioning whether we should also review the other articles written by the author in the journals' backfile, based on the following:
1. The institutional report cited serious systemic concerns with the research and findings.
2. The author was highly influential.
3. Many of the articles were published in the 1970s/1980s or earlier.
4. Other areas of the author's work/findings seem contrary to current scientific standards (and potentially harmful).
Question(s) for the COPE Forum
When responding to an institutional report recommending retraction of certain articles, should editors review the other works of an author as part of their response (and depending on the reasons the retraction was recommended and the potential relevance to the author's other articles, issuing an editor's note or expression of concern to reference the concerns identified in the report findings for the separate retractions).
With respect to articles in the journal's historic backfile that reference findings that have since been overturned by later works and do not meet current scientific standards (and are potentially harmful or are supportive of a practice that has since been prohibited), is it appropriate for journal editors to initiate their own review of these articles? Should these articles be retracted, or would these cases be more appropriately handled with a “statement of concern” alerting readers to the concerns with the article's findings
Is retraction an appropriate action so long (decades) after publication?
The Forum agreed this is a difficult case and one that increasingly arises in historic papers with questionable data practices. This is a reflection of a wider problem of how far back to go if there are problems with the data. Data maintenance practices in the past may not always have been very good. It is up to editors to have a look at the papers and see if there's anything very obviously wrong that could be investigated but if it is a general suspicion that the data might not be correct but there is no way to validate this, then an expression of concern might be appropriate.
There is a presumption that the institution must have had specific reasons why the 10 papers should be retracted and not the other ones. If the data are not available and it cannot be proved that there was any manipulation or whether the findings are correct for the other papers, then retraction would be inappropriate, and a statement of concern should be considered, given that the author cannot reply. If an author has committed misconduct, does that mean their whole body of work is invalid? The Forum suggested applying retraction to the 10 articles. For the other articles, a statement of concern for the other papers is appropriate if there is clear evidence of misconduct. Retraction for these articles is not appropriate unless the institution provides sound evidence that the data sets were manipulated or fraudulent.
For the 10 publications that the institution has suggested retracting, are there any living co-authors that could provide more information? The editor might consider contacting any co-authors for more information.
Regarding the fact that the findings of the previous articles may be unsafe, from the institutional perspective, this may not mean a danger to public health. Sometimes institutions use the term unsafe with regard to relying on the data that back the study. Perhaps unsafe means that there is little to support the actual findings and they should be disregarded or looked at it from an historical perspective. The advice was for the editor to apply common sense. There are many practices and treatments (eg, cancer treatments) that have changed dramatically over time and would be considered completely unsafe today, but we would not consider retracting those papers.
Two journals had published 10 articles that were identified by the deceased author’s institution as “unsafe” and recommended for retraction. The editors of these two journals reviewed the institution’s findings and agreed with the recommendation to retract. A retraction notice was issued by each journal for the related articles. The editors of these two journals also issued an expression of concern linked to the other articles by the author that were not identified in the institutional report. The expression of concern alerts readers to the separate institutional report and findings, informing readers that the articles linked to the expression were not part of the institutional review.
Several other journals published articles by the author that were outside the area of research by the institutional review and therefore not listed in the institutional report. The editors of each of these journals were alerted separately to the institutional report so that they could review the articles published in their journals and determine if any action was appropriate. To date, none of the editors have published an expression of concern or taken any other action.
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.
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.
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?
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.
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.
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 Virginia Barbour, Muhammad Irfan, Deborah Poff and Michael Wise on behalf of COPE Council Version 1 December 2016 How to cite this COPE Council. Journals’ Best Practices for Ensuring Consent for Publishing Medical Case Reports. Version 1. December 2016 https://doi.org/10.24318/cope.2019.1.6
Our COPE materials are available to use under the Creative Commons Attribution-NonCommercial-NoDerivs license https://creativecommons.org/licenses/by-nc-nd/3.0/ Attribution — You must attribute the work in the manner specified by the author or licensor (but not in any way that suggests that they endorse you or your use of the work). Non-commercial — You may not use this work for commercial purposes. No Derivative Works — You may not alter, transform, or build upon this work. We ask that you give full accreditation to COPE with a link to our website: publicationethics.org
As editor of a psychology journal, I received a manuscript from a group of scholars. The authors describe a qualitative online study with adolescent girls, aged 15–18 years, who met in person with a stranger they first ‘met’ online. The girls describe their reasoning about the risks, the safety measures they used and reactions to discomfort they experienced in the meetings.
The authors noted on our required information form that they “Confirm that all the research meets the ethical guidelines, including adherence to the legal requirements of the study country.” They also note in their cover letter that the paper conforms to APA (American Psychological Association) standards.
In the paper, the authors note that “parental consent was not required” because “all of the participants were older than 15 at the time of the interview, which is the legal age in the country where the study was performed”.
Because they identified the source of a number of quotations from the interviews that they conducted as being from 15 year olds, I contacted the first author for clarification. I also asked where the statute is listed that states 15 years as the age of consent in your country and also asked if the study was reviewed by an ethical review board.
The author confirmed that the legal age is 15 years and the sentence should have read “all the participants were 15 years old or older.” They agreed to correct the paper. They stated 15 years was set in the project as the age where they would not require parental consent, but the youths themselves were informed about the procedure as well as their rights and agreed to participate. They said the law does not require informed consent when personal data (ie, data that could directly connect the information collected to the specific person) are not being gathered and stored during the process (with the exception of biomedical research). Hence institutional review board approval was not required and the project was therefore not reviewed by an ethical board. However, the project proposal contained a detailed description of the procedure, including the ethical aspects. The project proposal was approved by a university, and evaluated, approved and funded by a grant agency.
My concern is about the age of the participants. Does the Forum have a recommendation regarding the requirements for parental approval for participants as young as 15 years, even if the legal age of consent is 15?
Question(s) for the COPE Forum • What is COPE's position on research on 15–18 year olds without parental permission in a country where the legal age of consent is 15 years?
The Forum suggested there are two issues here: the age of legal consent without parental approval and the ethical issue.
While the study has institutional backing, some of the Forum were of the opinion that the study should have been reviewed by an institutional review board. Only an institutional review board or an ethical board can judge whether or not consent should have been obtained.
One view was that parents should have been informed for the younger aged participants (15 and 16 year olds). However, another view was that the benefits outweigh the risks, and that if the parents had been informed, that may have prevented the participants taking part in the study. The age of consent varies widely in different countries. If participants are over the age of consent for that particular country and the study was done according to national standards, then the authors should be allowed to publish. A suggestion was that if the paper is accepted for publication, the editor could put a statement or note on the paper around the issue of consent, in the cultural context. It may also be useful for the editor to write an editorial comment as readers may also have similar questions.
Since many journals have international authors, should the onus be on editors if there is lack of clarity to confirm the norms elsewhere. Do we need universal standards for issues like this?
The reviews for the article were returned and the article was rejected based on the merit of the paper. The matter regarding this specific submission is closed. The authors followed the letter of the law in their country, but the editor still wonders if there should be a universal age for consent of minors, without parental approval. There are many sides to the issue.