A graduate student submitted a paper to a journal and noted that in her country, unless the research is directly medical, institutional review board (IRB) approval is not required or completed. The journal has a policy of requiring IRB approval on any human subjects’ research. This study was looking at practitioners and their work with students having a particular diagnosis.
The editor received a note from the author with the information that in the country of origin, no ethical approval was required on a master’s thesis. The study was conducted in accordance with ethical principles of the Helsinki declaration. The author noted that the results of the master’s thesis might be of importance and could make a contribution to the literature. It was supported by the university that sponsored the thesis but had not gone through an IRB.
Question(s) for the COPE Forum
- 1. Is there ever a time when IRB approval should not be required before review and publication of research?
- 2. How strictly should the editor adhere to these requirements? With this submission, it would be an automatic reject without IRB approval.
The Forum noted that institutional review board approval was the topic for discussion at the previous COPE Forum on 8 July 2014. A summary of the discussion and comments can be found on the COPE website (http://publicationethics.org/files/u661/Foruum_Discussion_Summary_Fair%20play%20for%20researchers_final.pdf).
The Forum advised common sense in approaching this case. Is the study of value? Does the editor have any concerns regarding the research or any other ethical concerns? If not, and the editor wishes to publish the paper, she should obtain proof from the authors that the study does not require ethics approval. This could be in the form of guidelines from the country in question, or a letter from an institutional review board (IRB) stating that the study does not require ethics approval. Hence the editor should ask the author to provide a written report on why the study did not require ethical approval.
The Forum agreed that it would be harsh to penalise the authors if they have done an ethical study within the framework of their local laws, which can vary greatly from country to country.
Of course, there is no guarantee that a study is ethical even if it does have approval from an IRB, so the editor should always be wary.
The Forum noted that transparency is important, and if the study is published, the editor may want to publish a notice explaining why it was published in the absence of IRB approval.
Another suggestion was for the editor to ask her editorial board members to review the paper and seek their opinion, and to help establish guidelines for future cases.
After receiving the Forum’s advice, the editor established an ethics committee of members of the editorial advisory board. The editor presented the question to them and also forwarded the submitted manuscript. The sample was small, and the editorial advisory board agreed that individuals could be identified in the community of origin which would negate the assurance of anonymity. The editor rejected the article.