Considering sex as a biological variable in preclinical research

Area of Science:

• Preclinical Research
• Biomedical Science
• Research Methodology

Background:

• The National Institutes of Health (NIH) issued guidance in June 2015 (NOT-OD-15-102) requiring sex as a biologic variable in research.
• Anticipating this, the NIH Office of Research on Women's Health convened a workshop in October 2014 to discuss integration methods.
• The workshop addressed practical methods, experimental design, and statistical analyses for including both sexes in preclinical studies.

Purpose of the Study:

• To provide a guide for preclinical investigators on incorporating sex as a biologic variable.
• To discuss methods and techniques for including both male and female animals, cells, and tissues in research.
• To consider gender as a potential modifier of biological processes.

Main Methods:

• The article builds upon a workshop focused on practical methods for sex integration.
• Discussion includes experimental design and statistical approaches for preclinical research.
• Considers the use of both male and female biological samples (animals, cells, tissues).

Main Results:

• The article serves as a guide for investigators on considering sex as a biologic variable.
• It outlines practical methods for the inclusion of both sexes in preclinical research.
• It does not prescribe exhaustive or specific compliance approaches.

Conclusions:

• Integrating sex as a biologic variable is crucial for robust preclinical research.
• The guide aims to assist researchers in adopting sex-inclusive methodologies.
• Adherence to these principles enhances the biological relevance and applicability of research findings.