New FY25 Policy on Sex as a Biological Variable in Research

This message is to notify the research community of the recently signed Fiscal Year 2025 (FY25) Congressionally Directed Medical Research Programs (CDMRP) Policy on Sex as a Biological Variable (SABV) in Research and associated changes to application requirements.

Beginning with applications submitted to FY25 funding opportunities, the CDMRP expects researchers to study both males and females unless there is a strong justification from the scientific literature, preliminary data, or other relevant considerations for only studying one sex. This policy applies to all applications and awards for CDMRP-supported research involving vertebrate animals, humans and/or material of human origin (e.g., cadaveric specimens, tissues, cell lines, and their derived data) where the sexes are known.

As specified in the policy, applicants will be required to include a strategy for considering SABV and, for studies that will consider SABV by including both sexes, applicants will be expected to develop a data analysis plan prospectively that, at a minimum, will collect data disaggregated by sex.  In Department of Defense reports and peer-reviewed publications, funded investigators will be required to acknowledge limitations in the applicability of findings that may arise from the samples, methods, and analyses used and report sex-based differences and/or disaggregate data based on sex where possible.

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The complete policy and a Frequently Asked Questions document are available under the “Resources and Reference Material” section on the electronic Biomedical Research Application Portal (eBRAP) (https://eBRAP.org).  Please refer to the detailed descriptions of funding opportunities, evaluation criteria, and submission requirements which can be found in each Program Announcement.

All applications must conform to the final Funding Opportunities/Program Announcements and General Application Instructions which can be found on the Grants.gov website (https://Grants.gov).  A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. Applicant organizations must be registered in SAM (https://www.sam.gov/SAM/) and receive confirmation of an “Active” status before submitting an application through Grants.gov.

For email notification when CDMRP funding opportunities are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).

For more information on types of funding opportunities offered and application strategies, review the CDMRP Webinar Series: https://cdmrp.health.mil/pubs/Webinars/webinar_series.

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Last Updated on July 30, 2024