Inclusion of sex and gender in biomedical research: survey of clinical research proposed at the University of Pennsylvania

• DOI: 10.1186/s13293-017-0139-5
• Publication Date: 2017-06-21T14:50:04Z
• Authors: Anne Freeman; Patrick Stanko; Lily N. Berkowitz; Neanta Parnell; Anastasia Zuppe; Tracy L. Bale; Tracy Ziolek; C. Neill Epperson
• Keywords: Institutional review board

The 2015 National Institutes of Health (NIH) policy that sex be considered as a biological variable (SABV) is now critical part the peer-review process for NIH funding well publication in several high-impact scientific journals. We sought to determine degree which biomedical researchers at University Pennsylvania already consider SABV or gender their research. reviewed 240 research protocols approved by Investigational Review Board (IRB) consecutively submitted between January and July 2016. Each protocol was searched terms sex, gender, male, female, man, woman justifications related population under study. A PubMed search conducted current state knowledge regarding potential and/or differences with respect topic. Data were summarized using descriptive statistics. Of 165 (68.8%) included one terms, only 24 (14.5%) provided justification choice sex/gender studied. Sixty-three percent (n = 151) focused on topics extant literature supports least moderate some aspect disorder/condition being these, three (2.0%) indicated investigator would impact primary outcomes. subset IRB major institution suggests very few investigators are considering important variables clinical stage development. IRBs an excellent position encourage order enhance rigor design, maximize importance resulting knowledge, ensure subject selection equitable. These findings serve basis developing intervention level development submission will promote consideration factors import patient safety efficacy interventions.