Assuring integrity in Obstetrics and Gynecology research

Abstract

It is vital for clinicians, policymakers, and researchers in any healthcare field to be confident that the research methods and outcomes of published studies can be trusted. Increasing attention is being paid to the integrity of scientific research in the fields of Obstetrics and Gynecology, as in many other healthcare fields. The number of retracted articles throughout the scientific literature has increased greatly in recent years,1 with high-profile allegations of research misconduct making international headlines in 2020,2 and recently 129 retracted manuscripts in the field of Obstetrics were identified in Retraction Watch or PubMed.3 Peer-reviewed journals must continue to re-evaluate and refine their processes in order to protect against fraudulent and questionable research. While we recognize that it may never be possible to prevent misconduct and fraud in published literature entirely, over the past year IJGO has taken a number of steps to improve editorial processes in a bid to safeguard research integrity. We have particularly focused our efforts on clinical trials, since these inform evaluation of the effectiveness of different types of healthcare interventions, which in turn inform treatment decisions and practice guidelines. In January 2022 IJGO appointed its first Research Integrity Editor to the Editorial Board—a role that has a dual function. The first function of the Research Integrity Editor role is to review and assess any queries that may arise relating to the integrity of published IJGO articles. Any such cases are assessed in line with Committee on Publishing Ethics (COPE) guidance,4 and in cases where further investigation is warranted the IJGO Editorial Office will request responses and (where appropriate and available) raw data from the authors and their institutions for review by the Research Integrity Editor and Editor-in-Chief. We work closely with the Integrity in Publishing Group of our publishing partner, Wiley, on these cases. Such investigations take time and must be worked through systematically and according to best practice. On the basis of post-publication research integrity review, we have recently retracted a randomized controlled trial (RCT) published in 2016,5 and we continue to investigate a number of other cases. The second function of the role is to proactively assess the integrity of any newly submitted clinical trial papers, as well as any non-RCT papers for which integrity concerns have been flagged by reviewers. The Research Integrity Editor carries out a first-pass review of each new clinical trial submission, and only RCTs that are judged to be satisfactory at this stage will continue to full peer review. This review stage evaluates clinical trials against a stringent checklist, which covers areas such as clarity and appropriateness of research objectives; ethics; trial registration; methodology; reporting of results; and relevance of conclusions drawn, among others. This review stage has been in place for all new RCT submissions as of January 2022. Editorial office processes and author guidelines have also been improved to ensure adherence to best practice, particularly in relation to RCTs. Following screening of new submissions by the Editor-in-Chief or Deputy Editor-in-Chief for scope, the IJGO Editorial Office checks for compliance with a number of clinical trial requirements outlined in IJGO's author submission guidelines,6 in accordance with a set of recommendations recently co-authored by our Editor-in-Chief and a number of other major OBGYN journal Editors.3 Among these requirements are the stipulations that: clinical trials must be registered prospectively in a named public trials registry (with registration number and URL provided); the manuscript must contain a statement of approval by an institutional Ethics Board (with name and reference ID provided); and there must be a statement of adherence to CONSORT Guidelines. We also require inclusion of a data-sharing statement (and we strongly encourage authors to share data where possible); a COI statement for all authors; acknowledgment of any funding sources; an author contributions section stating how each individual author contributed to the study; and a completed author questionnaire for each co-author, stating that they fulfill all of the ICMJE authorship criteria.7 In line with most scientific journals, all manuscripts are also screened using plagiarism detection software prior to acceptance. As Anderson et al. note,3 it is preferable to prevent trials with scientific misconduct from being published in the first instance, rather than retract them post-publication. We are confident that our improved editorial processes, stricter author guidelines, and increased scrutiny of clinical trials will help to cement the reputation of IJGO as a journal of trusted research and integrity.

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