Opportunity Information: Apply for PAR 24 100
The NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required), funding opportunity number PAR-24-100, is a National Institutes of Health (NIH) discretionary grant that supports the actual implementation of investigator-initiated clinical trials that are considered high-risk, along with mechanistic studies that are directly tied to those high-risk trials. The overall aim is not only to test interventions in people, but also to generate deeper biological or immunological insight while the trial is underway, since mechanistic work embedded in a clinical trial can clarify how and why an intervention works (or does not), improve understanding of human disease processes, and help guide future therapeutic development. NIAID encourages applicants to align proposed work with its mission and priority research areas, and points investigators to NIAID program information at https://www.niaid.nih.gov/research/role.
This opportunity uses a cooperative agreement (U01) mechanism, meaning the award is intended to involve substantial scientific or programmatic involvement from NIAID staff compared with a traditional investigator-initiated research project grant. It is specifically designed for clinical trial implementation rather than early conceptual development, and it requires a clinical trial. A key structural limitation is that each application may propose only one clinical trial, so applicants need to focus the submission around a single, well-justified study rather than bundling multiple trials under one award.
Eligibility is broad and spans many organization types. Eligible applicants include state, county, city, township, and 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; nonprofits with and without 501(c)(3) status (excluding institutions of higher education where specified); for-profit organizations (other than small businesses); small businesses; and other organizations. The NOFO also explicitly highlights additional eligible applicant categories 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 federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).
The funding activity category is Health, and the associated CFDA number listed is 93.855. The notice was created on January 29, 2024, and the original closing date is January 13, 2027. The listing does not provide an award ceiling or expected number of awards in the supplied data, so applicants would need to consult the full NOFO and NIH budget guidance for limits, budgeting expectations, and any institute-specific considerations.Apply for PAR 24 100
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2024-01-29.
- Applicants must submit their applications by 2027-01-13.
- 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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FAQs: NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) - PAR-24-100
What is the PAR-24-100 funding opportunity?
PAR-24-100 is a National Institutes of Health (NIH) discretionary grant opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) that supports the implementation of investigator-initiated clinical trials. It is specifically intended for clinical trials considered high-risk and for mechanistic studies that are directly tied to those high-risk trials.
Which NIH institute is offering this opportunity?
This opportunity is offered by NIAID (the National Institute of Allergy and Infectious Diseases), which is part of the NIH.
What is the main purpose of this grant?
The goal is to support the actual implementation of a high-risk clinical trial in people while also generating deeper biological or immunological insight through mechanistic studies embedded in the trial. Mechanistic work conducted during the trial can help clarify how and why an intervention works (or does not), improve understanding of human disease processes, and inform future therapeutic development.
Does the opportunity require a clinical trial?
Yes. The funding opportunity is explicitly a "U01 Clinical Trial Required" mechanism and is designed for clinical trial implementation rather than early conceptual development.
What does "clinical trial implementation" mean in the context of this opportunity?
Based on the description provided, the opportunity is meant to support the conduct and execution of an investigator-initiated clinical trial, not just planning or early-stage idea development. Applicants are expected to be ready to implement the proposed trial as part of the award.
What makes a trial "high-risk" for this program?
The opportunity targets investigator-initiated clinical trials that are considered high-risk. The specific criteria for what qualifies as "high-risk" are not detailed in the provided summary; applicants would need to consult the full NOFO for how NIAID defines and evaluates high-risk clinical trials under this program.
Are mechanistic studies allowed or encouraged?
Yes. Mechanistic studies are supported and are intended to be directly tied to the high-risk clinical trial. The aim is to generate biological or immunological insight while the trial is underway.
Do mechanistic studies need to be connected to the clinical trial?
Yes. The description specifies that mechanistic studies must be directly tied to the high-risk trial, meaning they should be integrated with and relevant to the intervention and outcomes being tested in the clinical trial.
What is the funding mechanism for PAR-24-100?
The mechanism is a cooperative agreement (U01). This differs from a traditional research project grant because it is intended to include substantial scientific or programmatic involvement from NIAID staff.
What does "substantial involvement from NIAID staff" imply?
Because this is a U01 cooperative agreement, the award is intended to involve more active participation by NIAID staff compared with a standard investigator-initiated grant. The provided summary does not define the exact nature of that involvement, so applicants should refer to the NOFO for details.
How many clinical trials can be included in one application?
Only one clinical trial may be proposed per application. Applicants must focus the submission around a single, well-justified study rather than combining multiple trials under one award.
Is this opportunity meant for early conceptual work or for executing a study?
It is specifically designed for clinical trial implementation rather than early conceptual development.
Should applicants align their research with NIAID priorities?
Yes. NIAID encourages applicants to align proposed work with its mission and priority research areas. The opportunity points investigators to NIAID program information at https://www.niaid.nih.gov/research/role.
What is the funding activity category?
The funding activity category listed for this opportunity is Health.
What is the CFDA number associated with this opportunity?
The associated CFDA number listed is 93.855.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including government entities, educational institutions, nonprofits, and for-profit entities, as well as U.S. and non-U.S. organizations (foreign organizations).
Are state and local government entities eligible?
Yes. Eligible applicants include state, county, city, township, and special district governments.
Are school districts eligible?
Yes. Independent school districts are listed as eligible applicants.
Are universities and colleges eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments are eligible, and tribal organizations that are not federally recognized are also listed as eligible.
Are nonprofits eligible?
Yes. Nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status are included among eligible applicants (with exclusions noted in the eligibility language where specified).
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also listed as eligible.
Are faith-based or community-based organizations eligible?
Yes. The NOFO explicitly highlights faith-based or community-based organizations as eligible applicant categories.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are explicitly listed among eligible applicant categories.
Are foreign (non-U.S.) organizations eligible?
Yes. Non-U.S. entities (foreign organizations) are explicitly listed as eligible.
Are certain institution types specifically highlighted as eligible?
Yes. The opportunity explicitly highlights additional eligible categories 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), and others.
Are federal agencies eligible applicants?
Yes. Eligible federal agencies are explicitly included among eligible applicant categories.
When was this notice created?
The notice was created on January 29, 2024.
What is the original closing date for this opportunity?
The original closing date listed is January 13, 2027.
Does the listing provide an award ceiling?
No. The supplied data does not include an award ceiling. Applicants would need to consult the full NOFO and NIH budget guidance for limits and budgeting expectations.
Does the listing state the expected number of awards?
No. The supplied data does not provide the expected number of awards. Applicants should consult the full NOFO for any details on anticipated awards or funding levels.
Where can applicants find more information about NIAID mission and priority areas?
NIAID program information is referenced at https://www.niaid.nih.gov/research/role.
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