A publisher received a submission to one of their journals that raised ethical concerns. The concerns were related to potential harm or undue risk for participants who may be vulnerable.
The publisher reviewed the ethics approval statement, and the authors had met the journal’s policy requirements by prospectively obtaining ethics approval from their institution before beginning the research. The authors provided the approval number and contact details on request.
The publisher gave the authors an opportunity to justify the ethical argument for the research, and the paper and the author's responses were discussed at the publisher’s own ethics committee. The ethics committee felt that the authors had good intentions and the research question was important, but agreed that the paper constitutes unethical research (particularly as the participants were considered vulnerable to some degree).
The paper has been rejected but the publisher feels it is important to follow up on the concerns regarding the institution's ethics board that approved the study.
Questions for the Forum
- Is contacting the institution/institutional review board directly the appropriate action?
- Is contacting the institution/institutional review board too "soft-touch"? Is there an ethical obligation to ensure this is escalated to a higher body?
- In this case, the institutional review board is not in the same country as the journal. Is there an international ethics approval body that holds ethics boards accountable?
The Forum asked if the editor had contacted more senior people at the institution. The Forum suggested seeking out a higher body, such as the ministry of health or office of research integrity. Many countries have organisations that oversee research institutions, although the Forum warned that the journal needs to weigh up the possible risks to the author if they are reported to their institution or higher authority.
The Forum noted that there is no global body overseeing research worldwide. The Forum asked if there was a funding body involved in the research. Funding bodies often have their own guidelines for conducting research.