NEWS RELEASE

Department of Defense
United States Army Medical Research and Development Command
Congressionally Directed Medical Research Programs

Released: August 5, 2024

FORT DETRICK, Md. – On July 18, CDMRP published a policy to ensure females and males are appropriately included in the design of CDMRP-funded research. Intentional consideration of biological variables, like sex, in medical research improves our understanding of health and disease in men and women. This policy takes effect beginning with applications submitted to fiscal year 2025 CDMRP funding opportunities, contingent on FY25 congressional funding for CDMRP-managed programs.

According to the new policy, developed in consultation with the National Institutes of Health, sex is defined by characteristics encoded in DNA, such as reproductive organs and other physiological and functional characteristics. Gender refers to social, cultural, and psychological traits linked to males and females through social context.

This policy complements CDMRP’s existing policy on the Inclusion of Women and Minorities as Subjects in Clinical Research established in October 2020.

Both sex and gender shape health and disease outcomes, and these policies require investigators to consider sex and gender in the research design.

Preclinical research historically relied on male animals or often omitted identifying the sex of animal subjects, creating challenges to understand how diseases and health conditions impact males and females.

Through policy implementation, CDMRP-funded research must consider the known and potential sex differences in disease prevalence, presentation and outcomes. There are also established sex-related differences in the action of pharmaceuticals and basic physiology that can impact intervention design. The new policy notes that the failure to account for SABV can undermine the rigor, transparency and impact of research findings. Sex continues to be a critical component of rigorous scientific and medical research design.

CDMRP research awards funded with prior fiscal year funding are exempt from this policy. In addition to CDMRP’s existing application components, this policy requires investigators to outline their strategy for considering SABV. Research on health conditions, topics, and diseases that impact a single sex, like ovarian or prostate cancer, are also exempt from this policy.

During the two-tier review process, the peer and programmatic panels will consider how well the plan for considering SABV is incorporated into the proposed research, the potential generalizability among sexes, and the plan for data analysis that captures sex-based differences.

“This policy is an important step toward ensuring results from CDMRP-funded research will have the greatest impact,” Michelle Lane, LCSW-C, CT, CDMRP program manager involved in developing the new policy, said. “Considering SABV in all stages of research improves our ability to translate findings to both men and women.”

In FY24, the CDMRP received over $1.5 billion in congressional appropriations for research dedicated to enhancing the lives of Service Members and their Families, Veterans, and the American public. This funding targets critical gaps in research by focusing on innovative, high impact projects that will lead to cures, improvements in patient care, breakthrough technologies, and resources for clinical benefits.

For more information about the Congressionally Directed Medical Research Programs, our research programs, and research highlights, please visit the website at https://cdmrp.health.mil/.

Point of Contact:

CDMRP Public Affairs
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@health.mil

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