Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis (TBM) (R01 Clinical Trial Not Allowed) | PAR 18 822

Opportunity Information: Apply for PAR 18 822

The National Institutes of Health (NIH) funding opportunity titled "Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis (TBM) (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-18-822) supports research aimed at tackling one of the most severe forms of tuberculosis: tuberculosis meningitis. The overall goal is to stimulate innovative studies that clarify how TBM causes disease and disability and, based on that improved understanding, inform better therapeutic approaches. A central feature of this announcement is that it welcomes both clinical research and preclinical or other non-clinical research, as long as the proposed work is not a clinical trial. The FOA is explicitly interested in TBM both in people with TB alone and in individuals who also have HIV co-infection, reflecting the reality that HIV can substantially influence TB progression, immune responses, and outcomes.

The scientific focus of this opportunity is on disease mechanisms and improved outcomes, meaning applicants are expected to move beyond broad descriptions of TBM and instead pursue questions that can explain why the disease behaves the way it does and why current treatments often fail to prevent death or long-term neurologic injury. Projects might address the biology of Mycobacterium tuberculosis in the central nervous system, host immune and inflammatory pathways that drive tissue damage, the role of the blood-brain barrier and drug penetration, biomarkers that predict severity or response, or other mechanistic drivers that can be tied to future improvements in care. Because the FOA allows clinical research but disallows clinical trials, it is well-suited for studies such as observational cohorts, deep phenotyping of patients, analyses of clinical specimens, imaging-based investigations, laboratory experiments using patient-derived samples, animal models, or other translational approaches that build a bridge between bench and bedside without testing an intervention in a trial framework.

This is an R01 grant mechanism, which generally indicates support for substantial, hypothesis-driven projects of meaningful scope and duration. The opportunity is categorized as discretionary and uses the grant funding instrument, with the activity area listed under health. The CFDA numbers provided are 93.242 and 93.855, which correspond to NIH assistance listings relevant to infectious disease and biomedical research support. While an award ceiling is not specified in the provided data, the R01 mechanism typically funds well-justified budgets consistent with project needs and NIH policies, subject to institute-specific considerations and standard NIH review for scientific merit, feasibility, and potential impact.

Eligibility is broad and includes a wide range of domestic U.S. organizations and governmental entities, along with the ability for non-U.S. organizations to apply. Eligible applicants include state, county, and local 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; small businesses; and other applicant types as allowed by NIH. The FOA also highlights additional eligible applicant groups, emphasizing inclusion of Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); eligible federal agencies; faith-based or community-based organizations; Hispanic-serving institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American tribal governments other than federally recognized entities; tribally controlled colleges and universities (TCCUs); regional organizations; U.S. territories or possessions; and foreign organizations (non-domestic entities). This broad eligibility is consistent with the global burden of TBM and the need to support research where the disease is most prevalent, including international settings.

Administratively, the FOA was created on June 7, 2018, and the original closing date listed in the source data is September 4, 2020. The sponsoring agency is NIH. In practical terms, the announcement is designed to encourage strong mechanistic and translational science that can illuminate why TB meningitis leads to high mortality and neurologic sequelae and to lay the groundwork for more effective treatment strategies, including in the challenging context of HIV co-infection, without directly funding interventional clinical trials under this particular mechanism.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis (TBM) (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.855.
• This funding opportunity was created on 2018-06-07.
• Applicants must submit their applications by 2020-09-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

Apply for PAR 18 822

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