Opportunity Information: Apply for W81XWH 16 GWIRP CPA

  • The DOD-AMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Gulf War Illness Clinical Partnership Award" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
  • This funding opportunity was created on May 13, 2016 and posted on May 13, 2016.
  • Applicants must submit their applications by Oct 20, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The number of recipients for this funding is limited to 2 candidate(s).
  • Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
Apply for W81XWH 16 GWIRP CPA

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Opportunity Summary:

The DoD Gulf War Illness Research Program (GWIRP) Clinical Partnership Award (CPA) is a FY16 funding mechanism created to speed up progress in Gulf War Illness (GWI) diagnosis and treatment by deliberately pairing clinical and laboratory expertise in a way that is difficult to accomplish through a single investigator or single institution acting alone. The central idea is to move promising findings toward real-world clinical usefulness for Veterans with GWI, while also allowing clinical observations to loop back and shape biomarker discovery and pathophysiology research. In practice, the program is looking for projects that actively connect "bench and bedside" so that hypotheses can be generated from lab discoveries, population studies, or day-to-day clinical experience, and then refined through a reciprocal exchange of data, samples, and interpretation across the partnership.

A defining feature of this opportunity is the required multi-institutional, multidisciplinary team structure. Applications must be built around a partnership of two or three investigators: one Initiating Principal Investigator and one or two Partnering PIs. Each PI receives a separate award, but the work is meant to be tightly integrated, with all partners providing substantial intellectual leadership. The solicitation is explicit that a partnership does not meet the program intent if the clinician is simply providing access to patients or tissue samples without meaningful involvement in study design, interpretation, and the overall translational strategy. At minimum, the partnership must include at least one laboratory scientist and at least one clinician, where "clinician" means a properly credentialed care provider (with the necessary degrees, licenses, and certifications) at the institution of record. The team also has to demonstrate that it has, or can credibly access, a suitable and sufficient clinical care population of GWI patients to support the proposed work. Additionally, at least one partner must bring significant prior experience in GWI research, and applicants are expected to document credentials clearly in biographical sketches.

In terms of the science, the award is focused on research that informs and advances clinical practice rather than simply running standard treatment tests in a generic translational model. The opportunity encourages work such as tailoring or individualizing treatment approaches, exploring potential therapeutic options in a careful and clinically grounded way, and using clinical case series or other clinically derived datasets to inform biomarker development or deeper understanding of GWI biology. The solicitation frames translational research as a two-way continuum, meaning the strongest projects will show how lab insights guide clinical investigation and how clinical findings, including heterogeneity in patient presentation and response, feed back into mechanistic hypotheses, target identification, and future study design. The announcement even points applicants to a well-known translational research "developmental pathways" framework (originally created for cancer research) as a planning tool, emphasizing that the program values a clearly articulated pathway from discovery through steps that position the field for eventual clinical implementation.

This mechanism is not intended to fund full clinical trials. The program draws a clear line: a clinical trial, as defined here, involves prospective accrual of patients where an intervention (such as a drug, device, biologic, procedure, rehabilitation, or behavioral approach) is tested in humans for measurable outcomes related to safety, effectiveness, or efficacy. Instead of supporting that kind of trial, the Clinical Partnership Award may support correlative studies tied to an existing clinical trial, research that improves or optimizes the design of future trials, and limited exploratory clinical testing when the purpose is feasibility assessment or refinement of a device or intervention. Applicants who want to run a clinical trial are directed to use the FY16 GWIRP Treatment Evaluation Award mechanism rather than the CPA. The announcement also references additional human-subject guidance materials for distinguishing clinical trials from other forms of clinical research, signaling that applicants should be careful and precise in describing human-subject activities and regulatory implications.

From an administrative standpoint, the opportunity was issued by DOD-AMRAA under Funding Opportunity Number W81XWH-16-GWIRP-CPA, categorized as discretionary and offered via cooperative agreement and grant instruments under CFDA 12.420. Eligibility is described as unrestricted (open broadly to applicant entities, subject to any clarifications in the full text). The original and current closing date listed is October 20, 2016, with an expected two awards. The award ceiling is listed as 0 in the source record, which typically means the ceiling was not specified in that particular database field rather than implying no limit, so applicants would normally confirm budget limits in the full program announcement materials. Overall, the CPA is best understood as a team-science translational mechanism aimed at producing clinically meaningful, near-term advances for Veterans with GWI by forcing genuine collaboration between clinical care settings and research laboratories, while keeping the scope short of full-scale interventional clinical trials.

Frequently Asked Questions (FAQs): DoD Gulf War Illness Research Program (GWIRP) Clinical Partnership Award (CPA)

1) What is the GWIRP Clinical Partnership Award (CPA)?

The GWIRP Clinical Partnership Award (CPA) is a FY16 Department of Defense (DoD) funding mechanism designed to accelerate progress in Gulf War Illness (GWI) diagnosis and treatment by intentionally pairing clinical and laboratory expertise. The goal is to move promising findings toward practical clinical usefulness for Veterans with GWI, while also ensuring clinical observations feed back into biomarker discovery and pathophysiology research.

2) What is the main purpose of the CPA mechanism?

The CPA is meant to support tightly integrated, team-based translational research that actively connects "bench and bedside." Projects should show a two-way exchange where lab discoveries help shape clinical investigation and clinical findings (including differences in patient presentation and response) inform biological hypotheses, target identification, and future study planning.

3) What kind of partnership structure is required?

Applications must be built around a multi-institutional, multidisciplinary partnership of two or three investigators: one Initiating Principal Investigator and one or two Partnering PIs. Each PI receives a separate award, but the work must be designed as a single integrated effort with substantial intellectual leadership from all partners.

4) Is it required to include both a clinician and a laboratory scientist?

Yes. At minimum, the partnership must include at least one laboratory scientist and at least one clinician.

5) What does the program mean by a "clinician"?

For this opportunity, a clinician is defined as a properly credentialed care provider with the necessary degrees, licenses, and certifications at the institution of record.

6) Can a partnership qualify if a clinician only provides patient access or samples?

No. The solicitation explicitly states that the partnership does not meet the program intent if the clinician is simply providing access to patients or tissue samples without meaningful involvement in study design, interpretation, and the overall translational strategy.

7) Do applicants need access to Gulf War Illness patients?

Yes. The team must demonstrate that it has, or can credibly access, a suitable and sufficient clinical care population of GWI patients to support the proposed research.

8) Does the team need prior experience in Gulf War Illness research?

Yes. At least one partner must bring significant prior experience in GWI research, and applicants are expected to clearly document credentials in biographical sketches.

9) What types of research does the CPA encourage?

The CPA focuses on research that informs and advances clinical practice. Examples described in the opportunity include tailoring or individualizing treatment approaches, exploring therapeutic options in a careful and clinically grounded way, and using clinical case series or other clinically derived datasets to inform biomarker development or deeper understanding of GWI biology.

10) How does the CPA define translational research?

The CPA frames translational research as a two-way continuum. Strong projects are expected to show how laboratory insights guide clinical investigation and how clinical findings (including heterogeneity across patients) feed back into mechanistic hypotheses, biomarker discovery, and future study design.

11) Is the CPA intended to fund full clinical trials?

No. The mechanism is not intended to fund full clinical trials.

12) How does the opportunity define a clinical trial?

In this announcement, a clinical trial involves prospective accrual of patients where an intervention (such as a drug, device, biologic, procedure, rehabilitation, or behavioral approach) is tested in humans for measurable outcomes related to safety, effectiveness, or efficacy.

13) What kinds of human research activities may be supported if full clinical trials are not allowed?

The CPA may support correlative studies tied to an existing clinical trial, research that improves or optimizes the design of future trials, and limited exploratory clinical testing when the purpose is feasibility assessment or refinement of a device or intervention.

14) If an applicant wants to run a clinical trial, what mechanism should they use instead?

Applicants who want to run a clinical trial are directed to use the FY16 GWIRP Treatment Evaluation Award mechanism rather than the CPA.

15) What is the Funding Opportunity Number for this CPA announcement?

The Funding Opportunity Number is W81XWH-16-GWIRP-CPA.

16) Who issued this funding opportunity?

The opportunity was issued by DOD-AMRAA.

17) What type of funding instrument is used?

The opportunity is offered via cooperative agreement and grant instruments.

18) What is the CFDA number associated with this program?

The CFDA number listed is 12.420.

19) How is eligibility described?

Eligibility is described as unrestricted (open broadly to applicant entities), subject to any clarifications in the full announcement text.

20) What was the closing date for this opportunity?

The original and current closing date listed is October 20, 2016.

21) How many awards were expected?

The opportunity listed an expectation of two awards.

22) What is the award ceiling for the CPA?

The award ceiling is listed as 0 in the source record. In context, that typically indicates the ceiling was not specified in that particular database field rather than meaning there is no limit. Applicants would normally confirm budget limits in the full program announcement materials.

23) What makes a project responsive to the CPA program intent?

A responsive project should demonstrate genuine, integrated collaboration across the clinical and laboratory partners, including shared intellectual leadership and a clear plan for reciprocal exchange of data, samples, and interpretation. The work should be positioned to produce clinically meaningful advances for Veterans with GWI and should clearly articulate how discoveries move toward clinical implementation while also using clinical insights to refine scientific understanding.

24) Does the opportunity mention any planning framework for translational work?

Yes. The announcement points applicants to a translational research "developmental pathways" framework (originally created for cancer research) as a planning tool, emphasizing the value of a clearly articulated pathway from discovery through steps that position the field for eventual clinical implementation.

25) Are applicants expected to be careful in how they describe human-subject activities?

Yes. The opportunity references additional human-subject guidance materials for distinguishing clinical trials from other forms of clinical research, signaling that applicants should be precise about proposed human-subject activities and associated regulatory implications.

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