[Sex matters?! - Taking gender and diversity differences into account in (bio)medical research]

As of 2004, sponsors of studies submitted under the Clinical Trials Regulation are required to confirm that the chosen gender distribution is appropriate for identifying gender-specific differences-unlike research studies submitted under professional regulations. One of the best-known examples illustrates why sex and gender should also be taken into account in these types of studies: in the case of heart attacks, warning symptoms differ between men and women, resulting in women being less likely to receive guideline-based treatment and more likely to die than men. The objective of the present study was to obtain an overview of how gender-related aspects are considered in medical research projects submitted to an ethics committee for review.

The analysis of 171 research proposals submitted to the Ethics Committee of the University of Marburg in 2021 was conducted using two self-developed scoring systems. The first score assessed the extent to which gender and diversity aspects were considered in the research proposal. The second score evaluated the availability and quality of existing knowledge of gender and diversity differences related to the topic of each proposal, as reflected in the medical literature. Literature searches were performed in PubMed (PM) using a dedicated search string and in the GENDERMED database (GM).

A comparison of the two scoring systems indicates that in more than 70% of the research proposals that did not address gender or diversity aspects, the scientific literature nevertheless contained relevant evidence on gender- or diversity-related differences pertaining to the respective research topic.

This result is noteworthy, as institutions that support science and research, such as the German Research Foundation (DFG), have long been recommending that applicants appropriately consider sex/gender and diversity in the planning stage of their research projects.

Further studies are needed to determine which hurdles and barriers exist on the part of researchers. At key points within the research landscape, such as ethics committees, researchers could be made aware of these aspects at the planning stage and, where appropriate, be offered guidance.