NIAID Clinical Trial Implementation Cooperative Agreement (U01) | Apply Online

Opportunity Summary:

The NIAID Clinical Trial Implementation Cooperative Agreement (U01), Funding Opportunity Number PAR-13-151, was a National Institutes of Health (NIH) discretionary funding program run through the National Institute of Allergy and Infectious Diseases (NIAID). The core purpose of the announcement was to support the actual implementation of investigator-initiated clinical trials that are considered high risk, along with mechanistic studies that are conducted alongside those high-risk trials. In practical terms, this meant NIAID was looking to fund studies where the intervention, the population, the design, or the operational complexity introduced enough uncertainty that traditional funding mechanisms might be harder to justify, but where the potential scientific or clinical payoff could be significant. The emphasis on mechanistic work reflects a strong interest in using trials not only to test whether something works, but also to learn how and why it works (or fails), which can directly shape future treatment strategies and accelerate development of new therapeutics and prevention approaches in allergy, immunology, and infectious diseases.

This opportunity used the cooperative agreement mechanism (U01), which typically signals a more collaborative relationship between the awardee and the funding institute than a standard research grant. While the applicant would propose and lead the research, a U01 generally involves substantial programmatic involvement from NIH staff during the life of the award, especially around issues that are central to successful trial conduct such as milestones, study governance, coordination, and adherence to regulatory and policy requirements. The announcement was positioned around implementation, meaning it was aimed at supporting the infrastructure and activities needed to carry out a clinical trial rather than only early-stage concept development. Because the FOA highlighted “high risk” clinical trials, it implicitly covered the kinds of operational realities that make these trials challenging: participant recruitment and retention, multi-site coordination, complex protocols, novel endpoints, intensive safety monitoring, and the need for specialized laboratory or translational components tied to mechanistic aims.

The scientific scope aligned with NIAID’s mission areas, as reflected in the CFDA listings 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). Applicants were expected to be working in areas relevant to allergy, immunology, and infectious diseases, and to propose trials where embedded mechanistic studies could illuminate disease biology and immune responses in humans. Mechanistic studies in this context typically include things like immune profiling, pathogen sequencing, biomarker discovery and validation, pharmacokinetics/pharmacodynamics, correlates of protection, host response characterization, and other translational assays that can connect clinical outcomes to underlying biological processes. The FOA’s language suggests NIAID valued this “bench-to-bedside-and-back” loop, where clinical trials generate specimens and data that can inform future product development and refine hypotheses for subsequent studies.

Eligibility under PAR-13-151 was broad and inclusive across many organization types. Eligible applicants included nonprofits (both 501(c)(3) and those without 501(c)(3) status), public and private institutions of higher education, small businesses, and for-profit organizations (other than small businesses), as well as a wide range of government entities such as state governments, county and city or township governments, special district governments, and independent school districts. The FOA also explicitly welcomed participation from organizations that often receive targeted consideration in federal programs, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based and community-based organizations. Importantly, the announcement allowed foreign involvement: non-U.S. entities and foreign institutions were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by NIH policy were allowed. That combination points to NIAID’s interest in supporting clinical trials that may need to operate in international settings, for example where certain infectious diseases are endemic or where specific populations are best studied.

From an administrative standpoint, the opportunity was posted and created on March 22, 2013, with an original and final closing date of January 13, 2016, and an archive date of February 13, 2016, meaning it is no longer open for new applications under that specific announcement. The FOA did not require cost sharing or matching, which is consistent with many NIH funding opportunities and can lower barriers for applicants by not requiring them to bring a defined percentage of non-federal funds to the table. The funding instrument type was a cooperative agreement, and the activity category was Health, reinforcing that the expected outputs were clinical and translational in nature rather than purely basic research.

For practical navigation, the NIH listing referenced an additional information link to the full FOA text hosted on the NIH grants site (grants.nih.gov), where applicants would have found the detailed requirements typically associated with clinical trial implementation awards. Those details usually include expectations around trial readiness, clinical operations, data and safety monitoring, compliance with human subjects protections, and plans for oversight and reporting. The contact pathway included NIH Office of Extramural Research (OER) webmaster emails for technical issues accessing the announcement or troubleshooting links, which is standard for NIH postings and signals that scientific questions would normally be handled through the FOA’s designated program contacts in the full text.

Overall, PAR-13-151 was designed to fund demanding, investigator-driven clinical trials in NIAID-relevant disease areas, particularly those where the scientific uncertainty or operational complexity made the work “high risk,” and where adding mechanistic studies could substantially increase the value of the trial by explaining human biology and disease processes in ways that can guide the next generation of therapies, vaccines, diagnostics, or preventive interventions.

Browse more opportunities from the same agency: National Institutes of Health

Browse more opportunities from the same category: Health

Next opportunity: Bridging Cultures through Film International Topics

Previous opportunity: ROSES 2013 Advancing Collaborative Connections for Earth System Science

USGrants.org Applicant Portal:

Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.

Apply for PAR 13 151

 

[Watch] how do funding administrators access proposals?

Applicants also applied for:

Applicants who have applied for this opportunity (PAR 13 151) also looked into and applied for these:

 

Grant application guides and resources

It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!

Apply for Grants

 

 

Premium leads for funding administrators, grant writers, and loan issuers

Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.

If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.

Subscribe to Leads

 

Request more information:

Would you like to learn more about this funding opportunity, similar opportunities to "PAR 13 151", eligibility, application service, and/or application tips? Submit an inquiry below:

Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.