The FY20 SRP TRPA mechanism supports partnerships between clinicians and research scientists that will accelerate the movement of promising ideas in scleroderma into clinical applications.

This award supports the development of translational research collaborations between two or more investigators

credit:

to address a central problem or question in scleroderma in a manner that would be less readily achievable through separate efforts.Observations that drive a research idea may be derived from a laboratory discovery, population-based studies, or clinician’s firsthand knowledge of patients and anecdotal data.

The ultimate goal of translational research is to move a concept or observation forward into clinical application that is relevant to active duty Service members, Veterans, other military beneficiaries, and the American public.

However, members of the partnership should not view translational research as a one-way continuum from bench to bedside.

The research plan must involve a reciprocal flow of ideas and information between basic and clinical science.

There should be an intellectual synergistic partnership between the clinic and the laboratory.The success of the project must be supported by the unique skills and contributions of each partner.

The proposed study must include clearly stated plans for interactions between the Principal Investigators (PIs) and institutions involved.

The plans must include communication, coordination of research progress and results, and data transfer.

Additionally, multi-institutional applications must provide an intellectual and material property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award.The FY20 SRP TRPA requires multiple PIs.

At least two, and up to three PIs must partner in one overarching study.

One partner in the collaboration must be a research scientist and another must be a clinician.

In addition, one partner (research scientist or clinician) in the collaboration must be a New Investigator.

Multi-institutional partnerships are encouraged.

At least one member of the partnership must have experience in either scleroderma research or scleroderma patient care as demonstrated by active funding and/or recent publications.

A proposed project in which the clinical partner merely supplies tissues or access to patients will not meet the intent of this award mechanism.

One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission.

The Initiating PI cannot be a new investigator.

The other PI(s) will be identified as a Partnering PI(s).

All PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components.

If recommended for funding, each PI will be named to an individual award within the recipient organization.

For individual submission requirements for the Initiating and Partnering PIs, refer to Section II.D.2, Content and Form of the Application Submission.

It is the responsibility of the PIs to describe how their combined expertise will better address the research question and explain why the work should be done together rather than through separate efforts.New Investigator Collaboration:
The FY20 SRP TRPA mechanism requires that at least one of the PIs is an investigator in the early stages of their careers.

The New Investigator Collaboration is designed to support the continued development of promising independent investigators that are early in their faculty appointments.

All New Investigator PIs must meet specific eligibility criteria as described in Section II.C, Eligibility Information.This mechanism is intended to fund a broad range of translational studies, including, but not limited to, the following: Studies advancing/translating in vitro and/or animal studies to applications with human samples/cohorts. Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug (IND) application submission. Correlative studies that are associated with an open/ongoing or completed clinical trial and projects that develop endpoints for clinical trials. Animal studies must demonstrate potential for translation to patients.The following are significant features of the FY20 SRP TRPA: Preliminary Data:
Preliminary data are required but need not be from the scleroderma research field.

Preliminary data may include unpublished or published results from the laboratory of the PI or collaborators named on the application and/or data from the published literature relevant to scleroderma. Partnership:
The success of the project should depend on the unique skills and contributions of each partner. Translation:
The application should provide evidence for the reciprocal transfer of information between basic and clinical science, or vice versa, in developing and implementing the research plan.

The application should demonstrate how the study will leverage clinical information to address knowledge gaps, in resulting outcomes, validate key research findings, expand upon potentially transformative results, and/or investigate novel findings.

Describe how the research represents more than an incremental advancement in scleroderma research. Impact:
The application should describe research that seeks to understand the causes and progression of scleroderma and/or realizing improvements in patient care and/or quality of life. Relevance to Military Health:
The SRP seeks to support research that is relevant to the healthcare needs of military Service members, Veterans, and their families.

Relevance to military health will be considered in determining relevance to the mission of the DHP and FY20 SRP during programmatic review.

Investigators are strongly encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health:○ Use of military or Veteran populations, biospecimens, data/databases, or programs in the proposed research.○ Collaboration with Department of Defense (DoD) or Department of Veterans Affairs (VA) investigators.○ Involvement of military consultants (Army, Air Force) or specialty leaders (Navy, Marine Corps) to the Surgeons General in a relevant specialty area.○ Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to address a military need that also benefits the civilian population.○ Explanation of how the project addresses an aspect of scleroderma that has direct relevance to military Service members, Veterans, or other Military Health System beneficiaries, including environmental exposures.The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.The types of awards made under the Program Announcement will be assistance agreements.

An assistance agreement is appropriate when the Federal Government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.

S.

Government.

An assistance agreement can take the form of a grant or cooperative agreement.

The level of involvement on the part of the DoD during project performance is the key factor in determining whether to award a grant or cooperative agreement.

If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304).

Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement.

Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award.

The award type, along with the start date, will be determined during the negotiation process.The anticipated direct costs budgeted for the entire period of performance for an FY20 SRP TRPA will not exceed $750,00 0.

Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 202 1.

For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $ 2. 4M to fund approximately two Translational Research Partnership Award applications.

Funding of applications received is contingent upon the availability of Federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific 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 FY20 funding opportunity will be funded with FY20 funds, which will expire for use on September 30, 202 6.