A complainant raised six articles to the attention of the editor-in-chief, with concerns about ethical approval and possible conflicts of interest regarding the way that approval was granted. The studies all involved minority populations.
Ethics approval had been granted by the institutions for all of the manuscripts involved, along with written informed consent and corresponding ethics codes and approval, which all seemed to be in order. Nevertheless, there is some scepticism due to the political context and the nature of the authors’ affiliations, some of which are governmental.
Next step being considered are:
- asking the authors for more information about the conditions under which the consent was provided although it will be difficult to judge any claims
- publishing an expression of concern although the potential for resolution of an investigation is small and an expression of concern might seem heavy handed
- updating the complainant and ‘closing’ the case for now
Questions for the Forum
● To what extent should publishers question statements about ethical approval?
● Are there any alternative actions?
The case raised the question of how active a role should journals and publishers take in pursuing issues related to ethics approval. The Forum noted that publishers have a moral obligation to question ethics approval, especially if it has been brought to their attention. The editor could request that the ethics statement be expanded to include more about the nature of the voluntary consent that was provided. This is particularly relevant if vulnerable populations were involved. The statement should state how the authors ensured that the participants gave their consent voluntarily. The editor could use the vulnerable populations policy to justify questioning the research. The editor could also request that the documentation and discussions of the institutional review board be made available.
The editor could consider contacting the grant bodies or agencies, if there were any involved in the study. Funders often ensure that the correct ethical procedures have been followed, particularly in situations where there are difficulties gaining ethical approval (eg, if the research is carried out in a different country or the research is not affiliated to a university).
The Forum asked what triggered the complaint? The complainant requested retraction of the papers, but did the complainant supply evidence of problems with the ethics approval or conflicts of interest in the paper? Without specific evidence, the editor cannot assume there is a problem. The Forum advised that the complainant needs to provide evidence before any further action is taken by the journal or publisher. The onus is on the whistleblower to provide sufficient evidence to warrant a retraction.
The editor could have the articles in question reviewed by experts in the field to determine the added value of the papers to the literature before moving forward with any further action.
The journal editors-in-chief with expertise and/or relation to the manuscripts convened to further discuss the case, as there were a variety of opinions. The editors-in-chief and the editorial office have requested further details regarding ethics approval from the authors. No response has been received from the authors at this time, and therefore this has been escalated to related institutions or universities and a final deadline for response communicated. Once the deadline is reached, and if no or insufficient information has been provided, the editors and journal will consider whether retraction is appropriate on the basis that there is not sufficient information evidencing that the protocols complied with our editorial policies and ethical standards.
COPE position statement on The protection of vulnerable groups and individuals