A reader raised concerns on social media about whether informed consent for research reported in a published article was obtained. An investigation by the journal resulted in the publication of a correction explaining that written, informed consent was obtained from the research participants.
A separate, small group of researchers followed up and raised further questions regarding whether consent could have been free and informed, given the research participants were members of a potentially vulnerable population, and whether the authors had obtained the appropriate approvals from the institution where the research took place. A further investigation by the journal resulted in a note on the article to explain that the authors obtained ethical approval that was consistent with requirements at the time and with institutional and local guidelines. As far as the journal could determine, the participants who took part in the study were volunteers, were made aware of the study’s intent, and had provided appropriate approval for their data to be used in the research and its publication.
After some time, a member of the group of researchers followed up with a new line of inquiry regarding the article’s underlying data, specifically about when the data was collected and whether it was appropriately cited. This prompted a third investigation. At this point, the authors were no longer responding to the journal’s inquiries, and as a result, the journal issued an Expression of Concern on the article highlighting the uncertainty about when the data collection took place.
At the conclusion of each investigation, the journal decided that retraction of the article was not warranted because the research was carried out in accordance with local institutional standards and journal guidelines. Although the subject area of the article has the potential for dual use, they did not consider it appropriate to retract the article because ethics approval and informed consent had been obtained.
The journal received further follow-up from this same researcher alleging that the Editor-in-Chief had a conflict of interest because they had previously published with some of the authors of the article. However, the journal invites submissions on particular topics, and it is typical for the Editorial Board to invite submissions from their research colleagues in this field. The journal has a robust peer review process and previous research relationships are not an issue, so they did not consider it necessary to amend the article to clarify these points.
Most recently, the journal has received a letter from an institution where one of the article’s coauthors was affiliated. The institution stated that the coauthor neglected to receive its ethics approval in addition to the ethics approval that they had received from the original institution where the research took place. The institution requested that we retract the article and remove the institution’s affiliation from the co-author’s profile in the article.
Questions for COPE Council
- Does COPE Council agree with the journal’s decision not to retract the article? The journal has taken into consideration COPE’s recent position statement on the protection of vulnerable groups, the fact that the research was done around four years ago, and considerations around dual use. As far as they can determine, the research was carried out in accordance with local standards, the researchers received informed consent from the participants, and they had approval to undertake and publish the research from the institution where the research was carried out.
- In response to the institution, the journal has confirmed that the coauthor was a member of the faculty at the time the research was carried out and the article published. The journal does not think it would be appropriate to remove the author’s affiliation. Instead, they propose publishing a correction statement for the article explaining that the institution was not aware of and did not provide approval for the research, but noting that the authors did receive ethics and consent approval from the institution where the research took place. Would COPE Council agree with this proposed course of action—i.e., correcting the article rather than retracting because approval was received from the institution where the research was conducted?
Advice on this case is from a small number of COPE Council Members. Most cases on the COPE website are presented to the COPE Forum where advice is offered by a wider group of COPE Members and COPE Council Members. Advice on individual cases is not formal COPE guidance.
The case is quite challenging and goes more into research ethics.
The problem seems to be that the institution questions the fact that the researcher did not ask for ethics approval from the affiliated institution but from the institution where the research took place. It is not clear what the rules for ethics approval are at the affiliated institution. For example, was the research performed under a grant to that institution? It is also not clear which author held the grant and was the principal investigator, and which institutions collected data, and from which settings. Rules for ethics committee approval vary by country and institution, and depending on the type of research and contribution of the author (eg, was the author in question involved in only analysis and writing?). In some cases only the institution which holds the grant and where the principal investigator is employed and accountable requires ethics approval. Some institutions have to give administrative approval for any type of collaboration to declare possible conflicts of interest. But based on the information provided, retraction does not seem to be appropriate.
A correction statement for the article seems unnecessary. All of the data already exist in the published paper. The affiliation for each author is mentioned. Which institutional research ethics committee authorised the study is also known. If the institution does not agree with what their faculty member has published, the institution should publish its objection on its website. Furthermore, if the author’s action was unethical, the institution may take disciplinary action against their faculty, using the appropriate tools. However, it would be good for the journal to know about the requirements of each institution that participated in the study—at the time that the research was conducted—with respect to whether approval was required from them in addition to the institution at which the research was conducted. The journal might question whether the coauthor should have gained approval for any research activity from their institution as a condition of their contracted employment there. If this is the case, there may be grounds for the institution to have its affiliation to the coauthor/article removed.
The journal should check that their information and declarations in articles are clear and complete. Does the journal have a mechanism in place for alternative arrangements when peer reviewing papers when the Editor in Chief has a potential conflict of interest?