Opportunity Information: Apply for PAR 15 040
Apply for PAR 15 040
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigator Initiated Extended Clinical Trial (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 and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Nov 18, 2014 and posted on Nov 18, 2014.
- Applicants must submit their applications by Dec 4, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: County governments City or township governments Small businesses Independent school districts Public housing authorities/Indian housing authorities Private institutions of higher education Special district governments Public and State controlled institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) 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) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Investigator Initiated Extended Clinical Trial (R01) funding opportunity (PAR-15-040) is a National Institutes of Health (NIH) grant program designed to support the implementation of investigator-initiated, hypothesis-driven clinical trials that genuinely require a longer timeframe than the standard project period. The defining feature of this FOA is that it allows a 6- or 7-year project period specifically for clinical trial implementation, recognizing that some trials (because of enrollment realities, longer follow-up needs, endpoint timing, or operational complexity) cannot be completed responsibly within the more typical grant duration. Trials may be in any clinical phase, as long as they are hypothesis driven and align with the research mission of one of the participating NIH Institutes or Centers (ICs). A key expectation is that applicants consult with relevant NIH IC staff before submitting, since programmatic fit and trial scope are central to whether an application is appropriate for this mechanism.
This FOA is not meant to be a general-purpose clinical trial funding announcement; it is targeted to a narrower set of studies where the extended 6- or 7-year period is essential rather than merely convenient. In practical terms, that means the proposed trial should have a clear scientific rationale and a design that demands extended implementation time (for example, longer accrual windows, longer-term outcomes, or follow-up requirements). Trials that can reasonably be conducted within a standard timeframe are explicitly discouraged from using this announcement, since the intent is to reserve the extended period for studies where it is justified by the nature of the clinical question and the operational demands of the protocol.
From an administrative standpoint, the opportunity is categorized as a discretionary grant in the health area, using the R01 funding instrument. It is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research), reflecting the participating mission areas referenced in the listing. There is no cost sharing or matching requirement, which means applicants are not required to provide non-federal matching funds as a condition of the award.
Eligibility is broad and includes many types of domestic U.S. organizations and governments, such as state, county, city or township governments; public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and other nonprofit structures); for-profit organizations (including small businesses and other for-profits); independent school districts; special district governments; public housing authorities/Indian housing authorities; and tribal entities, including federally recognized tribal governments and other tribal organizations. The FOA also explicitly allows applications from non-U.S. entities, including foreign organizations and foreign institutions, and permits foreign components of U.S. organizations as allowed under the NIH Grants Policy Statement. Additional eligible applicant types called out include various minority-serving institutions (such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions), faith-based or community-based organizations, eligible federal agencies, regional organizations, tribally controlled colleges and universities, and U.S. territories or possessions.
Key dates in the listing show that the FOA was posted on November 18, 2014, with an original and current closing date of December 4, 2015, and an archive date of January 4, 2016, meaning the specific announcement as written is no longer active. The source directs applicants to the NIH Guide page for the full text of the FOA (PAR-15-040), and provides NIH Office of Extramural Research (OER) contact information for technical issues accessing or linking to the announcement.
Frequently Asked Questions (FAQs): Investigator Initiated Extended Clinical Trial (R01) - PAR-15-040
What is PAR-15-040?
PAR-15-040 is a National Institutes of Health (NIH) funding opportunity for an Investigator Initiated Extended Clinical Trial using the R01 grant mechanism. It is designed to support investigator-initiated, hypothesis-driven clinical trials that need a longer implementation period than the typical project length.
What is the main purpose of this funding opportunity?
The central purpose is to fund hypothesis-driven clinical trials where a 6- or 7-year project period is essential for responsible implementation. The extended timeframe is intended for trials that cannot realistically be completed within a standard project period due to factors like enrollment realities, longer follow-up needs, endpoint timing, or operational complexity.
What is the defining feature of this FOA compared to typical clinical trial funding?
The defining feature is the allowance of a 6- or 7-year project period specifically for clinical trial implementation. This longer duration is meant to accommodate trials that genuinely require extended time, not simply to provide additional convenience.
What type of study does this FOA support?
This FOA supports investigator-initiated, hypothesis-driven clinical trials that align with the research mission of one of the participating NIH Institutes or Centers (ICs). Trials may be in any clinical phase as long as they are hypothesis-driven and mission-aligned.
Are trials in any clinical phase eligible?
Yes. The opportunity allows trials in any clinical phase, provided they are hypothesis-driven and fit within the mission of a participating NIH Institute or Center.
Does the trial have to be hypothesis-driven?
Yes. The FOA specifically emphasizes investigator-initiated, hypothesis-driven clinical trials as the target of this program.
Is this FOA intended for any clinical trial that wants more time?
No. This is not a general-purpose clinical trial funding announcement. It is targeted to a narrower subset of studies where a 6- or 7-year implementation period is essential because of the trial design and operational demands.
What kinds of circumstances justify the extended 6- or 7-year timeframe?
The FOA highlights situations such as longer accrual/enrollment windows, longer-term outcomes, follow-up requirements, endpoint timing, and operational complexity as examples of why a trial may genuinely need the extended period.
Are trials discouraged from applying if they can be completed in a standard timeframe?
Yes. Trials that can reasonably be conducted within a standard timeframe are explicitly discouraged from using this announcement. The intent is to reserve the extended period for trials where it is justified by the nature of the clinical question and protocol demands.
What funding instrument is used for this opportunity?
The opportunity uses the NIH R01 funding instrument.
How is this opportunity categorized from an administrative standpoint?
It is categorized as a discretionary grant in the health area, using the R01 mechanism.
What CFDA numbers are associated with this opportunity?
The listing associates this FOA with CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research), reflecting participating mission areas referenced in the listing.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement, meaning applicants are not required to provide non-federal matching funds as a condition of the award.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic U.S. organizations and governments, including:
- State, county, city, or township governments
- Public and private institutions of higher education
- Nonprofit organizations (including 501(c)(3) and other nonprofit structures)
- For-profit organizations (including small businesses and other for-profits)
- Independent school districts
- Special district governments
- Public housing authorities / Indian housing authorities
- Tribal entities, including federally recognized tribal governments and other tribal organizations
- U.S. territories or possessions
- Eligible federal agencies
- Regional organizations
- Faith-based or community-based organizations
- Tribally controlled colleges and universities
- Minority-serving institutions (including HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions)
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA explicitly allows applications from non-U.S. entities, including foreign organizations and foreign institutions.
Are foreign components of U.S. organizations allowed?
Yes. The FOA permits foreign components of U.S. organizations as allowed under the NIH Grants Policy Statement.
Is consultation with NIH staff expected before submitting an application?
Yes. A key expectation is that applicants consult with relevant NIH Institute or Center staff prior to submission, because programmatic fit and trial scope are central to determining whether an application is appropriate for this mechanism.
Why is pre-submission consultation emphasized?
The FOA stresses consultation because the mechanism is intended for a specific subset of trials where extended implementation time is essential, and because alignment with a participating NIH Institute or Center mission is critical.
When was this FOA posted?
The listing indicates the FOA was posted on November 18, 2014.
What was the closing date for applications?
The listing shows an original and current closing date of December 4, 2015.
Is this FOA still active?
No. The listing includes an archive date of January 4, 2016, which indicates the specific announcement as written is no longer active.
Where can applicants find the full text of the FOA?
The source directs applicants to the NIH Guide page for the full text of the FOA (PAR-15-040).
Who should be contacted for technical issues accessing or linking to the announcement?
The listing provides NIH Office of Extramural Research (OER) contact information for technical issues related to accessing or linking to the announcement.
Does the FOA specify that the extended period is for implementation?
Yes. The defining feature described in the listing is a 6- or 7-year project period specifically for clinical trial implementation.
Is the FOA intended to cover trials with operational complexity?
Yes. Operational complexity is specifically mentioned as one of the reasons a trial may legitimately require the extended timeframe.
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