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.