Exploring the Mechanisms Underlying Modulation of Glymphatic-Lymphatic Systems by Complementary and Integrative Health Approaches (R01 Clinical Trial Optional) | RFA AT 21 001

Opportunity Information: Apply for RFA AT 21 001

This grant opportunity, titled "Exploring the Mechanisms Underlying Modulation of Glymphatic-Lymphatic Systems by Complementary and Integrative Health Approaches (R01 Clinical Trial Optional)" (RFA-AT-21-001), is a National Institutes of Health (NIH) discretionary research grant that supports mechanistic studies on how complementary and integrative health approaches may influence the body and brain waste-clearance and fluid-transport networks known as the glymphatic and lymphatic systems. The central focus is not whether a therapy "works" in the usual clinical sense, but how it might work biologically, especially in ways that change glymphatic/lymphatic activity or alter how these systems interact with normal physiology or disease processes. The FOA explicitly encourages projects that can explain underlying pathways, signaling, or functional changes, rather than projects designed to test clinical efficacy or effectiveness on patient-centered outcomes.

The research scope is broad as long as the work is clearly aimed at mechanisms. Applicants are invited to study how complementary and integrative health approaches regulate glymphatic or lymphatic functions directly, or how these approaches affect the relationship between glymphatic/lymphatic function and other physiological or pathological processes. Mechanistic work can be conducted in relevant animal models and/or in human participants, which gives investigators flexibility to use experimental designs ranging from preclinical mechanistic experiments to tightly controlled human mechanistic studies. Although the announcement is labeled "Clinical Trial Optional," it draws a firm boundary: it will not support clinical trials whose purpose is to evaluate efficacy or effectiveness on clinical outcomes. In practical terms, that means the human work needs to be framed around mechanistic endpoints (for example, biomarkers, imaging measures of flow or clearance, physiological readouts, or other measures that clarify biological action) rather than improvements in symptoms or disease endpoints as the primary goal.

The award mechanism is an NIH R01, meaning it is intended for substantial, hypothesis-driven research projects that can support a defined program of work. The listed award ceiling is $500,000 (as provided in the source data), and the FOA is categorized under health-related funding activities associated with CFDA numbers 93.121 and 93.213. The original closing date listed for this opportunity was July 9, 2020, and the FOA creation date is March 5, 2020, which is important for applicants reviewing timeliness and current NIH availability, since opportunities like this can be reissued, expired, or replaced by updated announcements.

Eligibility is expansive and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofit organizations (both 501(c)(3) and non-501(c)(3), other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organizations as allowed under NIH policy. The FOA also calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible agencies of the federal government, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.

Restrictions related to non-U.S. entities are clearly stated. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply directly, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, the FOA allows "foreign components" as defined in the NIH Grants Policy Statement, meaning a U.S. applicant organization can include certain international elements in the project when permitted and justified under NIH rules, even though a foreign institution cannot serve as the primary applicant.

In short, this FOA is aimed at researchers who want to unpack the biology connecting complementary and integrative health approaches to glymphatic and lymphatic system function, using rigorous mechanistic methods in animals and/or humans. It is a fit for teams with strengths in physiology, neurobiology, imaging, fluid dynamics, immunology, and related mechanistic disciplines who can define measurable glymphatic/lymphatic endpoints and articulate a clear pathway-based rationale, while avoiding a primary design centered on clinical efficacy testing.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploring the Mechanisms Underlying Modulation of Glymphatic-Lymphatic Systems by Complementary and Integrative Health Approaches (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213.
• This funding opportunity was created on 2020-03-05.
• Applicants must submit their applications by 2020-07-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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