NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) | PAR 18 633

FAQs: NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) - PAR-18-633

What is this funding opportunity?

This opportunity is the NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required), Funding Opportunity Number (FOA) PAR-18-633. It is a National Institutes of Health (NIH) discretionary funding program in the health area (CFDA 93.855) intended to support the implementation of investigator-initiated clinical trials, particularly those considered high-risk, along with mechanistic studies that are directly tied to the supported trial.

Which NIH Institute is sponsoring this FOA?

The sponsoring institute is the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

What does "Clinical Trial Required" mean in the title?

Based on the information provided, the FOA is designed specifically to support the implementation of a clinical trial. In other words, proposing a clinical trial is central to the purpose of this opportunity, and the application is expected to be built around carrying out that trial.

What types of projects is NIAID looking to fund under this FOA?

NIAID is looking for applicants who already have a strong, well-justified clinical trial concept and are ready to carry it out, especially when the trial is considered high-risk. The FOA also emphasizes mechanistic studies that are directly tied to the trial, meaning mechanistic data collection and analysis that complements the clinical outcomes and helps explain why an intervention works or fails.

What does "high-risk" mean in the context of this clinical trial implementation program?

In practical terms, the FOA frames high-risk trials as those involving higher uncertainty and/or complexity, and those that may carry meaningful challenges alongside the potential for meaningful impact. The opportunity is positioned for teams prepared to manage that uncertainty and implement the trial.

Are mechanistic studies required, or just encouraged?

The FOA highlights mechanistic work as a key value-add and encourages mechanistic studies that are directly tied to the clinical trial. The provided information describes mechanistic work as a priority emphasis because it can clarify disease biology in humans and explain trial outcomes, but it does not state (in the provided excerpt) that mechanistic studies are mandatory in every application.

What kinds of mechanistic studies fit this FOA?

Mechanistic studies should be directly connected to the clinical trial and designed to generate mechanistic data during the trial. The FOA describes mechanistic work as a way to explain why an intervention works or fails, clarify human disease biology, and lay groundwork for future therapies and better-designed studies.

How many clinical trials can be proposed in a single application?

Only one clinical trial may be proposed per application. The application should focus on a single, clearly articulated clinical study and, if included, its associated mechanistic components that complement the main trial.

Can an application include multiple trial concepts or multiple independent clinical studies?

No. The scope is explicitly tightly defined: one clinical trial per application. The mechanistic components should support and enhance that one trial rather than expanding into multiple trial concepts.

What award mechanism is used, and why does it matter?

This opportunity uses the cooperative agreement mechanism (U01). This matters because, unlike a purely investigator-directed award, a U01 typically involves substantial scientific or programmatic involvement by NIH (through NIAID) during the life of the award. The provided information notes that this involvement often includes collaboration on milestones, oversight of trial progress, and coordination around regulatory, operational, and reporting expectations.

How involved will NIAID be during the project period?

The FOA indicates that NIAID expects substantial scientific or programmatic involvement throughout the award, commonly through working with the awardee on milestones, monitoring trial progress, and coordinating expectations related to regulatory, operational, and reporting requirements.

Is this FOA limited to certain scientific areas?

Yes. The scientific emphasis is aligned with NIAID's broader mission and priority research areas. While the FOA supports investigator-initiated work, projects still need to fit within NIAID's scientific remit to be considered competitive and programmatically appropriate.

Where can applicants check whether their project fits NIAID priorities?

The FOA explicitly encourages investigators to consult NIAID online resources describing its research role and priorities at https://www.niaid.nih.gov/research/role.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic U.S. organizations and government entities, as well as additional categories explicitly called out by the FOA. The eligible applicants listed include:

• State, county, city or 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
• Native American tribal organizations that are not federally recognized tribal governments
• Public housing authorities and Indian housing authorities
• Nonprofits with 501(c)(3) status (other than institutions of higher education)
• Nonprofits without 501(c)(3) status (other than institutions of higher education)
• For-profit organizations other than small businesses
• Small businesses
• Other applicant types

Does the FOA encourage participation from specific institution types or communities?

Yes. The FOA specifically calls out additional eligible applicant categories, reflecting an interest in inclusive participation across institution types and communities. These include 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 faith-based or community-based organizations.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are explicitly listed among the additional eligible applicant categories.

Are federal agencies eligible to apply?

Yes. The FOA lists eligible federal agencies among the additional eligible applicant categories.

Are regional organizations eligible to apply?

Yes. Regional organizations are explicitly included in the list of additional eligible applicant categories.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. Non-U.S. entities (foreign organizations) are explicitly listed as eligible applicants in the provided information.

Is this opportunity limited to academic institutions?

No. While public and private institutions of higher education are eligible, the eligibility list also includes many government entities, nonprofits (with and without 501(c)(3) status), for-profits (including small businesses), tribal entities, housing authorities, community-based organizations, and foreign organizations.

What is the CFDA number associated with this program?

The CFDA number provided for this NIH health-area program is 93.855.

When was this opportunity originally posted?

The posted record lists a creation (original posting) date of February 6, 2018.

What was the original closing date?

The posted record lists an original closing date of January 13, 2021.

Does the public listing include an award ceiling or expected number of awards?

No. The provided information states that the public listing does not specify an award ceiling or the expected number of awards in the provided fields.

Where should applicants look for budget expectations or project period norms?

Because the public listing does not provide an award ceiling or expected number of awards, applicants would typically need to consult the full FOA text and current NIH guidance to understand budget expectations, project period norms, and any institute-specific limits or benchmarking information.

What is the main takeaway about the kind of team this FOA is trying to attract?

This opportunity is aimed at teams prepared to run a single, potentially high-impact but higher-uncertainty clinical trial within NIAID's mission space, ideally strengthened by mechanistic investigations that translate trial outcomes into deeper biological understanding and clearer next steps for future therapeutic development.