Considering Sex and Gender in Clinical Research
There is already research that identifies sex differences in the prevalence of common disorders, as well as the effectiveness of certain treatments within a sexually dimorphic population.
Penn PROMOTES has teamed with the University of Pennsylvania Institutional Review Board
Penn PROMOTES has teamed with the University of Pennsylvania Institutional Review Board (IRB) to encourage principal investigators to recognize sex/gender as an important variable when writing protocols for clinical research. This pertains to:
- Encouraging investigators to provide a rationale for the sex/gender profile of their study sample
- Encouraging investigators to investigate how sex or gender has an impact on primary or secondary outcomes described in a research protocol
In March 2017, Dr. Epperson presented on this mission to the IRB.
Useful resources:
NIH Office of Research on Women's Health
Canadian Institutes of Health Research
Relevant publications:
Freeman A, Stanko P, Berkowitz L et al. Inclusion of sex and gender in biomedical research: survey of clinical research proposed at the University of Pennsylvania. Biology of Sex Differences. 2017;8(1). doi:10.1186/s13293-017-0139-5.
Bale T, Epperson C. Sex as a Biological Variable: Who, What, When, Why, and How. Neuropsychopharmacology. 2016;42(2):386-396. doi:10.1038/npp.2016.215.