The FY21 TBIPHRP CRDA is intended to support planning and development activities necessary to initiate a future clinical study with the potential to have a significant impact on TBI and/or psychological health.

The future study to be developed at the conclusion of the CRDA may be clinical research

credit:

How's Your Community Doing?
Check Out it's
Community Vital Signs

or a clinical trial.A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

As stated in Section II.H.

2. c, Withdrawal, FY21 TBIPHRP CRDA applications that propose clinical research or a clinical trial in the CRDA period of performance may be administratively withdrawn.Clinical research is defined as:
(1) patient-oriented research.

Research conducted with prospectively enrolled human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.

Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.

Patient-oriented research includes:
(a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research.

Note:
Studies that meet the requirements for Institutional Review Board (IRB) Exemption 4 are not considered CDMRP-defined clinical research.

IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.FY21 TBIPHRP CRDA recipients are expected to be ready to apply for advanced funding in the program year following completion of their CRDA and are encouraged to apply for future TBIPHRP funding through an appropriate FY23 or FY24 TBIPHRP program announcement or targeted broad agency announcement, if offered.

Release of FY23 or FY24 TBIPHRP funding opportunity announcements and any subsequent awards will be contingent upon the appropriation and availability of federal funds for the program and competitive selection.

Award of an FY21 TBIPHRP CRDA is in no way an assurance of funding for future TBIPHRP awards.Implementation Research:
FY21 TBIPHRP CRDA planning and development activities may support innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines.

Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (“de-implement”) the use of interventions that are ineffective, unproven, low-value, or harmful.

In addition, studies to advance dissemination and implementation research methods and measures are encouraged. For the purposes of the FY21 TBIPHRP CRDA, implementation research is defined as the scientific study of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health.Preliminary data are required.

The FY21 TBIPHRP CRDA is a planning award and is not intended to support preclinical or clinical studies to generate preliminary data or proof-of-principle.

However, the FY21 TBIPHRP CRDA may be used to support the generation of preclinical data requested by the FDA as a condition to initiate a clinical study.

Applicants proposing such experiments should include evidence of communication with the FDA in Attachment 2, Supporting Documentation.

Use of animals and human anatomical substances/data is permitted; however, this award may not be used to conduct prospectively enrolled human subject clinical trials or clinical research.Applicants looking to submit applications for clinical trials should apply to the FY21 TBIPHRP Clinical Trial Award mechanism (Funding Opportunity Number:
W81XWH-21-S-TBIPH1).Applicants seeking funding for other research studies may consider applying to the following FY21 TBIPHRP funding opportunities: FY21 TBIPHRP Idea Development Award (Funding Opportunity Number:
W81XWH-21-TBIPHRP-IDA) Investigator-Initiated Research Award (Funding Opportunity Number:
W81XWH-21-TBIPHRP-IIRA) Translational Research Award (Funding Opportunity Number:
W81XWH-21-TBIPHRP-TRA)Planning activities that may be supported by the FY21 TBIPHRP CRDA include, but are not limited to: Planning for appropriate regulatory approvals (for example, IRB submissions and FDA submissions such as FDA Investigational New Drug [IND]/Investigational Device Exemption [IDE] applications) Composing the research team and initiating collaborations (including community-based organizations and lived experience consultants) necessary for the future clinical research project Developing the research plan and statistical design Developing the clinical protocol Establishing access to appropriate patient populations or resources Developing training procedures Planning for potential intellectual or material property issues Developing a transition plan with associated resources and collaborations to continue to the next phase of research, including involvement of industry partners, if applicable Developing a data analysis/statistical plan and/or modeling for clinical research/trial design Cross mapping of data elements to TBI and/or psychological health common data elements (CDEs) Note:
FY21 TBIPHRP CRDA applicants are encouraged to reference the FY21 TBIPHRP Clinical Trial Award (Funding Opportunity Number:
W81XWH-21-S-TBIPH1) to become familiar with its requirements and to help direct proposed activities during the CRDA period of performance.Relevance to Military Health:
Relevance to the healthcare needs of Service Members, Veterans, military beneficiaries, and the American public is a key feature of this award.

Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health: Explanation of how the project addresses an aspect of TBI and/or psychological health that has direct relevance to the health and/or readiness of Service Members, Veterans, military beneficiaries, and the American public Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to benefit the civilian population and also address a military need Use of military or Veteran populations, samples, or datasets in the proposed research, if appropriate Collaboration with DOD or Department of Veterans Affairs (VA) investigators or consultantsApplicants are encouraged to integrate and/or align their research projects with DOD and/or VA research laboratories and programs.

Collaboration with the DOD or VA is also encouraged.

A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 2. 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 total costs budgeted for the entire period of performance for an FY21 TBIPHRP CRDA will not exceed $300,00 0. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 202 2. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $3M to fund approximately 10 FY21 TBIPHRP Clinical Research Development 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 FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 202 7.