Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Jennifer Shankle Grantor

Description:

“It is the policy of my Administration to advance women’s health research, close health disparities, and ensure that the gains we make in research laboratories are translated into real-world clinical benefits for women. It is also the policy of my Administration to ensure that women have access to high-quality, evidence-based health care and to improve health outcomes for women across their lifespans and throughout the country.” – President Joseph R. Biden, Jr., Executive Order 14120 on Advancing Women’s Health Research and Innovation, 18 March 2024.

In support of the President’s Executive Order to advance women’s health research, the PRORP is releasing this WHRA funding opportunity. The intent of the FY24 PRORP WHRA is to support research focused on orthopaedic issues faced by women serving in military settings, such as infantry and other physically demanding roles, who have sustained orthopaedic injuries. The overall goal of the WHRA is to address factors that contribute to the health and retention of women in military service. Although use of military populations, datasets, or samples are not required, the application should demonstrate how the proposed research relates to issues faced by women serving in military settings. The proposed research project should also include a well-formulated, testable hypothesis based on sound scientific rationale and logical reasoning.

Although the PRORP is interested in supporting military-focused research, research supported by the PRORP is expected to also apply to all individuals who have sustained a major orthopaedic injury.

The PRORP encourages applications from a spectrum of research areas, including but not limited to translational and clinical research. The PRORP also welcomes qualitative research, population science, and health care services research specifically designed to understand the impact of orthopaedic injuries on female Service Members.

With the initiation of the Arthritis Research Program, the FY24 PRORP may not fund arthritis research; however, research that addresses conditions or health abnormalities related to arthritis is permitted provided the proposed research addresses the PRORP WHRA’s focus on orthopaedic injuries in women.

A key feature of the PRORP WHRA is the relevance to female military and/or Veteran populations following orthopaedic injury. Inclusion of female military and/or Veteran populations is highly encouraged for applications proposing clinical research. Applicants proposing clinical studies in non-military and/or non-Veteran populations must justify the relevance of the proposed research to the military and/or Veteran communities. All applicants should clearly describe how their study design, including recruitment strategies and access to appropriate populations, as applicable, will enable them to meet this intent.

Research involving human subjects, human datasets, and human anatomical substances is permitted; however, the WHRA may not be used to conduct clinical trials. Applicants seeking support for a clinical trial should consider the FY24 PRORP Clinical Trial Award (Funding Opportunity Number HT942524PRORPCTA).

Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:

(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.

(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.

(3) Outcomes research and health services research that do not fit under the definition of clinical trial.

Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule.

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.

Rigor of Experimental Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies. Projects that include research on animal models are required to submit Attachment 7, Animal Research Plan, as part of the application package to describe how these standards will be addressed. Applicants should consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.

Encouraged Department of Defense (DOD) and/or VA Collaboration: Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the VA, and other federal government agencies are encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

The funding instrument for awards made under the program announcement will be grants (31 USC 6304).

The anticipated total costs budgeted for the entire period of performance for an FY24 PRORP WHRA should not exceed $1.5M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards supported with FY24 funds will be made no later than September 30, 2025.

The CDMRP expects to allot approximately $3.0M to fund approximately two WHRA applications. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org