In 2017, the editors of an anonymous journal asked the Committee on Publication Ethics (COPE) for advice regarding a study involving more than 200 pregnant patients who had a systemic illness. COPE is an international organization that provides best-practice guidance for scholarly publishing ethics. In the study that the editors submitted to COPE for adjudication, participants were assigned to a control group in which patients received routine antenatal care or to an active intervention group in which patients had active surveillance and management of their systemic illness during pregnancy. The journal’s editors and reviewers were concerned about the ethics of the study because of the significant morbidity and mortality in the nonactively managed control group. “[I]t 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’,” they claimed. Their question to COPE was, “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 reviewers at COPE concluded that the study appeared to employ “unethical research conduct” and was an “egregious violation of human ethics.” COPE’s stance was that if a treatment is known to be effective, withholding it from vulnerable patients in unethical.
While this COPE case raises awareness and concern about research practices as a whole, it also raises an important point specific to scholarly publishing: Just because authors claim to have institutional review board (IRB) approval does not mean their research is ethical. Peer reviewers and journal editors must review study reports carefully to ensure the study was conducted in accordance with ethical principles and not simply rely on author claims of IRB approval. To assist with the process, editors can ask authors to provide documentation such as a copy of the IRB/ethics board letter and proof of patient consent. Papers that raise too many questions or concerns can be rejected. If issues come to light after publication, journals can issue corrections or retractions. Editors and reviewers are the gatekeepers; it is their responsibility to provide ethics oversight in the publication process.
The Ochsner Journal editorial staff reviews submitted manuscripts for ethical compliance and requires proof of patient consent when necessary. We are currently working on a human subject protection theme issue of the Journal that will be published in Spring 2020 and will feature articles discussing the history of human research ethics as well as current ethics-related topics.