An article was submitted involving over 200 pregnant patients with a systemic illness (from 2010 to 2015) who were recruited and assigned to a control group or an active intervention group (of their systemic illness). The control group received routine antenatal care while the intervention group had active surveillance and management of their systemic illness during the pregnancy.
There was a significant increase in morbidity and mortality in the non-actively managed control group. We (reviewers and editors) are concerned about the ethics of this study design. Specifically, it seems pregnant patients who were assigned to the non-active treatment/control group did not have their systemic condition managed in what would today be regarded as 'standard of care'.
Question(s) for the COPE Forum
• Despite apparent local ethics board approval, and a statement from the authors declaring adherence to the Declaration of Helsinki, is it ethical to include a non-active intervention group for a disease which is known to have negative fetal and maternal outcomes?
The Forum advised that this appears to be unethical research conduct and egregious violation of human ethics.
Withholding known effective treatment for experimental purposes is not ethical in human subjects’ research. If there is a known effective treatment, the study cannot ethically be done, and any institutional review board would raise a question about such a protocol. If the active management (treatment) is not known to be effective, and the researchers are attempting to establish efficacy of the active management, then a rigorous research protocol should be in place. Such a protocol would ensure informed consent of all human subjects, as well as a process for breaking the randomization if it becomes clear that the subjects in the control arm of the research are in any medical jeopardy. If this is not the case in this research, the authors should be reported to a research integrity office at their institution or at the country level.
Editors can reject a paper for ethical concerns despite local ethics approval, and a journal can ask the institution to reassess this approval. If it is known that a treatment/management is effective, withholding it is unethical.
The manuscript was rejected for a variety of reasons, including the concerns regarding the ethics of the study design.