Reproducibility of Biological Laboratory Variables

Over the past decade, funding bodies in the United States, Canada, and Europe have instituted policies mandating that basic experimental researchers consider sex as a biological variable in their research. As a result, basic scientists who work with materials such as cell lines, roundworms, zebrafish, and mice are now grappling with the question of how to consider sex as a biological variable in laboratory models. This project aims to develop a clarifying account of research constructs for studying biological sex. The aim is to improve rigor, reproducibility, and precision in the study of biological sex in laboratory models and to promote constructive critical dialogue in policy debates and across disciplinary boundaries. This research project will investigate the conceptual foundations of research paradigms for the study of biological sex in basic, preclinical, nonhuman biological research. The project will use a case study approach to analyze four research programs across the fields of drug metabolism, endocrinology, behavioral science, and genetics, and examine diverse models from gene expression assays to in vitro organ cultures to animal models. Through these case studies, the project will analyze scientific practices surrounding the question of how to study sex as a biological variable. Specifically, the project will analyze uses and meanings of the variable of biological sex within the design, analysis, interpretation, and communication of laboratory-based scientific research. Through in-depth case studies, interviews, statistical reanalysis of sex difference claims, and conceptual analysis, this project will study practices in laboratory research on sex-related variables across a range of fields and generate an account of how biological laboratory variables are constructed and embedded across contexts and practices. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.