Periodically, COPE gets requests for the development of discussion documents, guidance and flowcharts on publication ethics issues related to book publishing. Many of our members publish both journals and books, and a number of these members reference COPE guidance on journal publishing and ethics as providing useful information on particular topics related to research and publication ethics.
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.
Author Developed by COPE Council Version 1 August 2018 How to cite this
COPE Council. What to consider when asked to peer review a manuscript (Latin American Spanish). Version 1. 2018. https://doi.org/10.24318/ cope.2019.2.28
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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.
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?
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?
Authors in any subject area have always had a number of potential publications to choose from when they decide that they want to publish their research. As well as subscription journals to pick from, the increasing number of Open Access models has meant that the choices for authors are expanding all the time. A new type of publication that has arisen from the OA movement is the European Geosciences Union (EGU) and Copernicus model of open peer review and “Discussion” journals, examples of which are:
There are a number of legitimate and valuable tools for gaining information and evidence for scientific advance and improving health care. These include research, evaluation, audit, and others. There is a real danger that UK “researchers” using tools other than “research”, duly following guidance in UK research regulation stating a lack of need for ethical review, find that journal editors will not consider their manuscript for publication because editors dispute the definition of what needs or does not need ethical review.