Opportunity Information: Apply for PAR 10 184
Apply for PAR 10 184
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Implementation Grant (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on May 5, 2010 and posted on May 5, 2010.
- 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: 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) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public and State controlled institutions of higher education For profit organizations other than small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Private institutions of higher education Native American tribal governments (Federally recognized) Small businesses County governments Special district governments Public housing authorities/Indian housing authorities.
- 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.
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Opportunity Summary:
The NIAID Clinical Trial Implementation Grant (R01) (Funding Opportunity Number PAR-10-184) is a National Institutes of Health funding opportunity designed to support the actual conduct and implementation of investigator-initiated clinical trials that are considered non-high risk. In practical terms, this program is aimed at researchers who already have a well-developed, hypothesis-driven clinical trial concept and are ready to move into the execution phase, rather than early-stage trial design or exploratory preparatory work. The proposed trial has to fit squarely within the National Institute of Allergy and Infectious Diseases (NIAID) research mission and align with areas NIAID considers a high priority, with applicants encouraged to consult NIAID planning priorities to ensure strong program relevance.
A key structural requirement is that each application may propose only one clinical trial. This means the application should be tightly focused on a single, clearly articulated clinical question, with a coherent protocol, analysis plan, operational approach, and feasibility justification. Because the FOA is specifically for implementation, applicants should expect that reviewers and program staff will look for evidence that the study is ready to launch and can be carried out successfully, including appropriate oversight, recruitment and retention planning, data and safety monitoring proportional to risk, and realistic timelines and milestones.
The funding mechanism used is the NIH R01 research project grant, which generally supports discrete, specified projects led by a principal investigator with defined aims and a structured plan. This FOA is part of a coordinated set of three related opportunities that cover different stages and risk profiles of investigator-initiated clinical trials. Specifically, it runs in parallel with PAR-10-185, which focuses on planning of investigator-initiated clinical trials, and PAR-10-186, which focuses on implementation of high-risk investigator-initiated clinical trials. Applicants are expected to select the FOA that best fits the maturity and risk category of their trial, since PAR-10-184 is intended for implementation of non-high risk trials rather than planning-only efforts or trials considered high risk.
A major administrative point is that pre-approval from NIAID is required before submitting an application under this FOA (and the two companion FOAs). This requirement effectively acts as an Institute-level screening step to confirm that the proposed trial matches NIAID priorities and is appropriate for the chosen FOA, and to help avoid applicants investing significant effort in an application that NIAID would not consider responsive or high priority.
On funding levels and award volume, the announcement does not set a fixed dollar amount or a guaranteed number of awards. Instead, the total amount awarded and the number of funded projects are contingent on the volume of submissions, the scientific and technical quality of the applications, and the proposed budgets, durations, and overall costs. This signals a competitive environment where strong alignment with NIAID priorities, solid scientific rationale, and credible operational execution plans matter heavily.
The opportunity is categorized as a discretionary grant in the health domain and is associated with CFDA numbers 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research). There is no cost sharing or matching requirement, which reduces financial barriers for applicants and is typical of many NIH research project grants.
Eligibility is broad and includes a wide range of U.S. and non-U.S. entities. Eligible applicants include nonprofits (both 501(c)(3) and certain non-501(c)(3) organizations), public and private institutions of higher education, for-profit organizations (other than small businesses are explicitly listed, but small businesses are also eligible), and various levels of government entities (state, county, city/township, special district, and independent school districts), as well as public housing authorities/Indian housing authorities. The FOA also explicitly includes additional categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, U.S. territories or possessions, regional organizations, and foreign (non-U.S.) entities. This wide eligibility range reflects the NIH’s interest in funding the best-qualified teams and institutions capable of running rigorous clinical trials aligned with NIAID’s mission.
From a timing and status standpoint, the FOA was posted May 5, 2010, with an original and current closing date of January 14, 2013, and an archive date of February 14, 2013. That means this particular announcement is no longer active, but it remains a useful reference for understanding how NIAID structures investigator-initiated clinical trial funding across planning and implementation phases and across risk categories. For the original full text and details, the announcement link was provided through the NIH grants guide at http://grants.nih.gov/grants/guide/pa-files/PAR-10-184.html, and NIH Office of Extramural Research web contacts were listed for access or technical issues.
FAQs: NIAID Clinical Trial Implementation Grant (R01) - PAR-10-184
What is PAR-10-184?
PAR-10-184 is the NIAID Clinical Trial Implementation Grant (R01), a National Institutes of Health funding opportunity intended to support the actual conduct and implementation of an investigator-initiated clinical trial that is considered non-high risk.
What stage of work is this funding meant to support?
This opportunity is aimed at researchers who already have a well-developed, hypothesis-driven clinical trial concept and are ready to move into execution. It is positioned for implementation activities rather than early-stage trial design or exploratory preparatory work.
What kinds of clinical trials are appropriate for PAR-10-184?
The proposed study must be an investigator-initiated clinical trial that is considered non-high risk, and it must fit within the NIAID research mission and align with areas NIAID considers a high priority.
Does the clinical trial need to align with specific NIAID priorities?
Yes. The trial must fit squarely within NIAID's mission and align with NIAID high-priority areas. Applicants are encouraged to consult NIAID planning priorities to ensure the work is programmatically relevant.
How many clinical trials can be proposed in one application?
Only one clinical trial may be proposed per application. The application is expected to be tightly focused on a single clinical question with a coherent protocol, analysis plan, operational approach, and feasibility justification.
What evidence of readiness is expected for an implementation application?
Because the FOA is specifically for implementation, reviewers and program staff are expected to look for clear signs the study is ready to launch and can be carried out successfully. Examples described include appropriate oversight, recruitment and retention planning, data and safety monitoring proportional to risk, and realistic timelines and milestones.
What is the funding mechanism used for this opportunity?
The funding mechanism is the NIH R01 research project grant, which generally supports discrete, specified projects led by a principal investigator with defined aims and a structured plan.
How does PAR-10-184 relate to PAR-10-185 and PAR-10-186?
PAR-10-184 is part of a coordinated set of three related opportunities for investigator-initiated clinical trials. PAR-10-185 focuses on planning of investigator-initiated clinical trials, and PAR-10-186 focuses on implementation of high-risk investigator-initiated clinical trials. Applicants are expected to choose the FOA that best matches the maturity and risk profile of their trial.
Is this FOA intended for trial planning only?
No. PAR-10-184 is intended for implementation. Planning-only efforts are described as being addressed through the companion planning FOA, PAR-10-185.
Is this FOA intended for high-risk clinical trials?
No. PAR-10-184 is described as supporting implementation of non-high risk trials. Implementation of high-risk investigator-initiated clinical trials is addressed under the companion FOA PAR-10-186.
Is pre-approval from NIAID required before applying?
Yes. Pre-approval from NIAID is required before submitting an application under this FOA (and the two companion FOAs). This functions as an Institute-level screening step to confirm the trial matches NIAID priorities and is appropriate for the chosen FOA.
Why does NIAID require pre-approval?
The pre-approval requirement helps confirm that the proposed trial is responsive to NIAID priorities and suitable for the FOA, and it helps avoid applicants investing significant effort in an application NIAID would not consider responsive or high priority.
Does PAR-10-184 specify a fixed award amount or number of awards?
No. The announcement does not set a fixed dollar amount or guarantee a specific number of awards. Total funding and the number of funded projects depend on submission volume, scientific and technical quality, and proposed budgets, durations, and overall costs.
What factors affect how many awards are made and at what funding level?
According to the opportunity description, awards depend on the volume of applications received, the scientific and technical merit of the applications, and the proposed budgets, durations, and total costs.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement.
What is the assistance listing/CFDA information associated with this opportunity?
The opportunity is associated with CFDA numbers 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
What is the general category of this grant?
It is described as a discretionary grant in the health domain.
Who is eligible to apply?
Eligibility is broad and includes a wide range of U.S. and non-U.S. entities. The FOA lists nonprofits (501(c)(3) and certain non-501(c)(3)), public and private institutions of higher education, for-profit organizations (including small businesses), and multiple levels of government entities (state, county, city/township, special district, independent school districts), as well as public housing authorities/Indian housing authorities.
Are minority-serving institutions explicitly included in eligibility?
Yes. The FOA explicitly includes categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.
Are faith-based and community-based organizations eligible?
Yes. Faith-based and community-based organizations are explicitly included among eligible applicants.
Are foreign (non-U.S.) entities eligible?
Yes. Foreign (non-U.S.) entities are explicitly included as eligible applicants.
Are U.S. territories or possessions included in eligibility?
Yes. U.S. territories or possessions are explicitly listed as eligible applicant categories.
Is this funding opportunity still active?
No. The FOA was posted May 5, 2010, with a closing date of January 14, 2013, and an archive date of February 14, 2013. Based on those dates, this specific announcement is no longer active.
Where was the original full announcement posted?
The original full text was posted through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-10-184.html.
What should applicants do if they are deciding between the three related FOAs?
Applicants are expected to select the FOA that best fits the maturity and risk category of their clinical trial: planning (PAR-10-185), implementation for non-high risk trials (PAR-10-184), or implementation for high-risk trials (PAR-10-186).
What core elements should a single-trial application cover?
The description emphasizes a single, clearly articulated clinical question supported by a coherent protocol, analysis plan, operational approach, and feasibility justification, along with practical readiness components like oversight, recruitment and retention planning, appropriate data and safety monitoring, and realistic timelines and milestones.
What does "implementation" mean in the context of this FOA?
In this context, implementation refers to funding the actual conduct and execution of a clinical trial, rather than concept development, early design work, or exploratory preparation.
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