We routinely ask for ethics committee approval from every research manuscript submitted to our journal. Sometimes, studies from different countries may not have ethics committee approval and authors may claim that their study does not need approval. In such situations, we consult COPE’s “Guidance for Editors: Research, Audit and Service Evaluations” document and evaluate the study at the editorial board and decide whether or not it needs approval.
However, as an editor, what should I do in the following situation? Any research, be it a retrospective analysis of routine patient data, an in vitro study or a study on bacteria requires institutional ethics committee approval in country A. In country B, ethics committee approval is not required for such studies (this information is provided by the authors). The journal receives two such studies, one from country A and one from country B. Neither has ethics committee approval. The authors of both manuscripts claim that their studies do not need approval.
Question(s) for the COPE Forum
• What should best editorial practice be in this situation?
—Accept both papers for review.
—Accept the paper from country B for review but reject the paper from country A (or ask the authors of the paper from country A to apply for institutional ethical approval).
—Reject both papers (or ask the authors of both papers to apply for institutional ethical approval).
The Forum noted that editors cannot be expected to know the national guidelines for the conduct of research in individual countries. It is up to authors to make sure that they comply with their national guidelines. One suggestion was that the national standards where the research was done should apply here, or the editor could make a judgement on his own national standards, in the country where the journal is located, and based on his knowledge of what he thinks requires ethics approval. It is good that the journal has a process for discussing this issue among its editorial board, to uphold minimum standards when the authors declare that they do not need ethical approval.
For country A, where ethics committee approval is required, the Forum suggested that the editor investigate whether the research does need ethics approval. It may be that the research is exempt from approval. But if the editor discovers that the study did require ethics approval and the authors failed to obtain approval, he has a responsibility not only to reject the paper but to follow this up with the author's institution and/or the ethics committee. Otherwise, the authors may just submit the paper to another journal.
For country B, the Forum suggested asking for proof that the study did not require ethics approval—for example, a letter from their ethics committee stating that the study does not require ethics approval.
The editorial board of the journal reviewed the Forum’s recommendations and have decided to continue to ask ethics committee approval for every study submitted to the journal from all countries. If the study requires ethics approval, the authors will be asked to provide this. If they cannot provide ethics approval, the journal will reject the manuscript and contact the institutions or related bodies in the authors’ country, if necessary. If a study does not need ethics committee approval after review, the journal will ask authors for confirmation from an ethics committee or an independent committee indicating that the study does not need ethics committee approval according to the research integrity rules in their country. The journal has updated their instructions to authors with these details.