Opportunity Information: Apply for PAR 11 234
Apply for PAR 11 234
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Implementation Cooperative Agreement (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jun 16, 2011 and posted on Jun 16, 2011.
- Applicants must submit their applications by Jan 14, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments Native American tribal governments (Federally recognized) Private institutions of higher education Small businesses 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 City or township governments Independent school districts County governments Special district governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities For profit organizations other than small businesses.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:
The NIAID Clinical Trial Implementation Cooperative Agreement (U01), Funding Opportunity Number PAR-11-234, is a discretionary National Institutes of Health (NIH) grant mechanism run through the National Institute of Allergy and Infectious Diseases (NIAID) to support the actual implementation of investigator-initiated clinical trials that are considered high risk. The opportunity is specifically geared toward hypothesis-driven trials, meaning applicants are expected to propose a clearly stated scientific question and a trial design that can credibly test that question, rather than purely descriptive or exploratory clinical activities. In addition to being scientifically well-framed, the proposed trial must align with NIAID's research mission in allergy, immunology, and infectious diseases and must fit within areas NIAID considers a high priority. NIAID explicitly points applicants to its planning priorities webpage for guidance on what topics and needs the Institute is emphasizing at the time.
This FOA uses the U01 cooperative agreement mechanism, which generally indicates a more collaborative funding relationship than a standard research grant, with substantial scientific or programmatic involvement from the funding institute during the life of the award. In practical terms, applicants should expect NIAID to play an active role in coordinating, overseeing, or otherwise partnering in key aspects of trial execution, which is particularly relevant for high-risk studies where safety oversight, protocol refinements, and operational decision-making can be complex. The funding activity category is Health, and the program is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). No cost sharing or matching is required, which means applicants are not expected to contribute a defined portion of project costs as a condition of award.
A central structural constraint of this opportunity is that only one clinical trial may be proposed per application. That limitation matters because it pushes applicants to focus their scope and budgeting around a single, well-justified trial rather than bundling multiple protocols, multiple independent trial questions, or a portfolio of studies under one submission. The FOA is oriented toward "implementation," which typically implies that the application should be ready to move into operational trial conduct (for example, finalized protocol concepts, feasible recruitment plans, clear site and data management strategies, and appropriate regulatory and safety oversight approaches), rather than being purely preclinical or planning-stage work.
Eligibility is broad and spans many types of organizations. Eligible applicants include state, county, city/township, special district, and certain school district governments; federally recognized Native American tribal governments and other tribal organizations; public and state-controlled institutions of higher education and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (including those outside academia); small businesses; and other for-profit organizations that are not small businesses. The FOA also allows applications from a wide range of mission-specific institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations. Importantly, non-U.S. entities (foreign organizations) and regional organizations are listed as eligible, and foreign components of U.S. organizations are allowed, which signals that international trial sites or collaborations may be permissible when scientifically and operationally justified and consistent with NIH policy.
From a timing standpoint, the FOA was posted and created on June 16, 2011, with an original and current closing date of January 14, 2013, and an archive date of February 14, 2013. That means the specific announcement is no longer open for new submissions under that exact solicitation, though similar NIAID clinical trial implementation opportunities may exist under newer FOAs. Applicants seeking the authoritative full text and detailed requirements were directed to the NIH Grants Guide posting at the provided link (http://grants.nih.gov/grants/guide/pa-files/PAR-11-234.html). For technical access issues, the contact listed is the NIH Office of Extramural Research (OER) Webmaster via FBOWebmaster@OD.NIH.GOV.
In summary, PAR-11-234 was designed to fund a single, investigator-initiated, hypothesis-driven, high-risk clinical trial that advances NIAID priority areas in allergy and infectious diseases, using a cooperative agreement structure that anticipates meaningful NIAID involvement during trial implementation, with broad eligibility across U.S. and certain non-U.S. organizations and no cost sharing requirement.
Frequently Asked Questions (FAQs): NIAID Clinical Trial Implementation Cooperative Agreement (U01) - PAR-11-234
What is PAR-11-234?
PAR-11-234 is a National Institutes of Health (NIH) funding opportunity announcement (FOA) from the National Institute of Allergy and Infectious Diseases (NIAID) titled "Clinical Trial Implementation Cooperative Agreement (U01)." It was designed to support the actual implementation of certain investigator-initiated clinical trials, particularly those considered high risk.
Which NIH institute runs this opportunity?
This FOA is run through NIAID (the National Institute of Allergy and Infectious Diseases), an NIH institute focused on research in allergy, immunology, and infectious diseases.
What type of funding mechanism is used?
The FOA uses the U01 cooperative agreement mechanism. A U01 is a discretionary NIH award type that typically involves substantial scientific or programmatic involvement from the funding institute during the project period.
What does "cooperative agreement" mean in practice for applicants?
Because this is a cooperative agreement (U01), applicants should expect NIAID to have an active role during the life of the award. Based on the FOA description, this can include coordinating, overseeing, or partnering in key aspects of trial execution, which may be especially relevant for high-risk trials that require careful safety oversight, protocol refinements, and operational decision-making.
What is the purpose of this FOA?
The purpose is to support the implementation (conduct) of investigator-initiated clinical trials that are considered high risk, provided they are hypothesis-driven and aligned with NIAID's mission and high-priority research areas.
What does "implementation" mean here?
"Implementation" indicates the application should be oriented toward operational trial conduct rather than purely preclinical or planning-stage work. The FOA description implies readiness elements such as feasible recruitment plans, clear site and data management strategies, and appropriate regulatory and safety oversight approaches.
Are exploratory or descriptive clinical activities appropriate for this FOA?
The FOA is specifically geared toward hypothesis-driven clinical trials. Applicants are expected to propose a clearly stated scientific question and a trial design that can credibly test that question, rather than proposing purely descriptive or exploratory clinical activities.
What scientific areas must the trial align with?
The proposed trial must align with NIAID's research mission in allergy, immunology, and infectious diseases, and it must fit within areas NIAID considers a high priority.
How can applicants determine NIAID's high-priority research areas?
NIAID explicitly points applicants to its planning priorities webpage to understand which topics and needs the Institute is emphasizing at the time.
Is this opportunity focused on high-risk trials?
Yes. The FOA states it supports the implementation of investigator-initiated clinical trials that are considered high risk.
How many clinical trials can be proposed in a single application?
Only one clinical trial may be proposed per application. This is a key structural constraint of the FOA.
Can an application bundle multiple protocols or multiple independent trial questions?
The FOA limits submissions to one clinical trial per application, which discourages bundling multiple independent trial questions or a portfolio of studies under one submission.
What is the funding activity category?
The funding activity category is Health.
Which CFDA numbers are associated with this FOA?
This program is associated with CFDA 93.855 (Allergy and Infectious Diseases Research) and CFDA 93.856 (Microbiology and Infectious Diseases Research).
Is cost sharing or matching required?
No. The FOA specifies that no cost sharing or matching is required, meaning applicants are not expected to contribute a defined portion of project costs as a condition of award.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including:
- Government organizations (state, county, city/township, special district, and certain school district governments)
- Federally recognized Native American tribal governments and other tribal organizations
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofit organizations with or without 501(c)(3) status
- Small businesses
- Other for-profit organizations that are not small businesses
- Mission-specific institution types such as HBCUs, Hispanic-serving Institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions
- Faith-based or community-based organizations
Are foreign (non-U.S.) organizations eligible?
Yes. Non-U.S. entities (foreign organizations) and regional organizations are listed as eligible in the FOA description.
Are foreign components of U.S. organizations allowed?
Yes. The FOA indicates that foreign components of U.S. organizations are allowed, suggesting international trial sites or collaborations may be permissible when justified and consistent with NIH policy.
When was this FOA posted?
The FOA was posted (created) on June 16, 2011.
What were the closing date and archive date?
The original and current closing date listed is January 14, 2013, and the archive date is February 14, 2013.
Is PAR-11-234 still open for applications?
No. Based on the closing and archive dates provided, the specific PAR-11-234 announcement is no longer open for new submissions under that exact solicitation.
Where can someone find the authoritative full text of the FOA?
The FOA directs applicants to the NIH Grants Guide posting at: http://grants.nih.gov/grants/guide/pa-files/PAR-11-234.html
Who is the technical contact for access issues related to the FOA posting?
The contact listed for technical access issues is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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