# Addressing Sex as a Biological Variable in Preclinical Pharmacology and Neuroscience Research: Accounting for Neglected Factors and Applying Practical Solutions to Enhance Rigor and Reproducibility

> **NIH NIH R25** · COHEN VETERANS BIOSCIENCE, INC. · 2020 · $125,235

## Abstract

Application ID: 339139
Addressing Sex as a Biological Variable in Preclinical Pharmacology and Neuroscience Research: Accounting for
Neglected Factors and Applying Practical Solutions to Enhance Rigor and Reproducibility
!
The National Institutes of Health (NIH) recently instituted a requirement to consider sex
as a biological variable in animal studies in an effort to ensure that preclinical research is
applicable to both males and females. This policy, however, has raised many questions
about how researchers should design studies that include both male and female rodents.
Although some resources provide guidance on this new requirement, most of these
guidelines focus on why sex is a critical biological variable rather than how to practically
implement these considerations into preclinical research design, analyses, and reporting.
We propose to develop a series of open-access online training modules that provide
preclinical researchers with the practical knowledge and guidance they need to conduct
rigorous and reproducible research that is applicable to both sexes. We aim to create
three modules, respectively entitled “Sex Differences and Study Design”, Sex Differences
in the Brain and Behavior”, and “Sex Differences and Pharmacology”. Each module will
consist of engaging short videos (“episodes”) that cover a single topic in the form of a
didactic presentation and case comparisons. The principal investigator and key personnel
will work with subject-matter experts to develop the modules. Furthermore, internal
evaluators will systematically monitor the program and perform a formative and
summative evaluation of its success on an ongoing basis. The evaluators will gather data
to determine whether the program is meeting its specific objectives and goals and
whether the training videos are helpful to preclinical researchers across all career stages
to understand how to address sex as a biological variable. We will make these training
modules freely available on YouTube by the second year of the funding period, and post
links to these modules across the Cohen Veterans Bioscience, European College of
Neuropsychopharmacology Preclinical Data Forum Network, Society for Neuroscience,
National Institute of General Medical Sciences, and Journal of Neuroscience Research,
and Partnership for Assessment and Accreditation of Scientific Practice websites. Our
goal is that the training modules will not only guide preclinical scientists to meet the NIH
grant requirement, but also to empower researchers to include both sexes in their studies.
PI: Patricia Kabitzke
Institution: Cohen Veterans Bioscience

## Key facts

- **NIH application ID:** 9985132
- **Project number:** 5R25GM133017-02
- **Recipient organization:** COHEN VETERANS BIOSCIENCE, INC.
- **Principal Investigator:** Chantelle Ferland-Beckham
- **Activity code:** R25 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $125,235
- **Award type:** 5
- **Project period:** 2019-07-29 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9985132

## Citation

> US National Institutes of Health, RePORTER application 9985132, Addressing Sex as a Biological Variable in Preclinical Pharmacology and Neuroscience Research: Accounting for Neglected Factors and Applying Practical Solutions to Enhance Rigor and Reproducibility (5R25GM133017-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9985132. Licensed CC0.

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