Opportunity Information: Apply for PAR 17 056
The Investigator Initiated Extended Clinical Trial (R01) funding opportunity (PAR-17-056) is a National Institutes of Health (NIH) grant announcement designed to support the implementation of investigator-initiated clinical trials that genuinely need a longer-than-usual timeline. The central feature is the extended project period: applications are intended for clinical trials that require 6 or 7 years to complete, reflecting situations where recruitment, follow-up, outcome accrual, or operational complexity makes a standard R01 timeframe insufficient. The FOA is specifically focused on running the clinical trial itself (implementation), not just early planning activities, and it emphasizes that the study must be hypothesis-driven, meaning it should be built around clear, testable scientific questions rather than being primarily exploratory or descriptive.
This opportunity is broad in terms of the kinds of trials it will consider. Trials can be in any phase, as long as they align with the research mission of one of the participating NIH Institutes and Centers (ICs). In practice, that means applicants need to ensure their topic, population, intervention, outcomes, and overall scientific purpose fit squarely within the priorities and statutory mission of an NIH IC that participates in this announcement. A key expectation is that prospective applicants communicate with NIH program staff before submitting an application. That pre-submission consultation is strongly encouraged because it helps confirm IC fit, clarify whether the proposed timeline and scope truly warrant a 6- or 7-year project period, and avoid developing an application that the NIH views as mismatched to the intent of the FOA.
The FOA also draws a clear boundary around what it is not meant to fund: it is not intended for clinical trials that do not require an extended 6- or 7-year project period. In other words, if a trial can reasonably be completed within a typical project duration, this announcement is not the appropriate mechanism. The emphasis is on justification of the extended timeline as a scientific and operational necessity, such as long-term follow-up to observe clinically meaningful outcomes, multi-site recruitment challenges, extended intervention delivery, or the need to measure endpoints that naturally take years to develop.
From an eligibility standpoint, the announcement is inclusive and allows applications from a wide range of organizations. Eligible applicants include various levels of government (state, county, city/township, and special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, and both federally recognized tribal governments and other tribal organizations. It also includes nonprofits with or without 501(c)(3) status, public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), and small businesses, as well as an "others" category that captures additional eligible entities. The FOA explicitly highlights additional eligible groups such as 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations.
Administratively, this is an NIH discretionary grant using the R01 funding instrument, within the Health funding activity category. The CFDA numbers associated with this opportunity are 93.855, 93.856, 93.859, and 93.866. The source information indicates the opportunity was created on 2016-11-17 and listed an original closing date of 2018-01-23. No award ceiling or expected number of awards is specified in the provided data, which is common for NIH FOAs where budgets and award counts can vary based on scientific merit, available funds, and IC priorities.
In plain terms, this FOA is meant for investigators who already have a well-developed, rigorous clinical trial ready to run, where the science requires a longer arc than usual. The best-fit applications are those that can convincingly explain why 6 to 7 years is essential to answer an important clinical question, show strong alignment with an NIH Institute or Center mission, and demonstrate readiness to execute a complex trial over an extended period with appropriate oversight, staffing, and operational planning.Apply for PAR 17 056
- 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, 93.856, 93.859, 93.866.
- This funding opportunity was created on 2016-11-17.
- Applicants must submit their applications by 2018-01-23. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs): Investigator Initiated Extended Clinical Trial (R01) - PAR-17-056
What is the Investigator Initiated Extended Clinical Trial (R01) opportunity (PAR-17-056)?
PAR-17-056 is a National Institutes of Health (NIH) funding opportunity announcement (FOA) that supports the implementation of investigator-initiated clinical trials that genuinely require a longer-than-usual project timeline. It uses the NIH R01 grant mechanism and is intended to fund the conduct of the clinical trial itself.
What is the central purpose of this FOA?
The central purpose is to fund clinical trials that need an extended project period of 6 or 7 years to complete because a standard R01 timeline would not be sufficient due to recruitment, follow-up, outcome accrual, or operational complexity.
How long can the project period be under this announcement?
Applications are intended for clinical trials that require 6 or 7 years to complete.
What kinds of clinical trials are supported (e.g., phase of trial)?
This FOA is broad and can support clinical trials in any phase, as long as the proposed trial aligns with the mission of a participating NIH Institute or Center (IC).
Does the FOA fund clinical trial planning, or the trial itself?
The FOA is focused on running the clinical trial (implementation). It is not intended to support only early planning activities.
Does the proposed study need to be hypothesis-driven?
Yes. The FOA emphasizes that the study must be hypothesis-driven, built around clear and testable scientific questions rather than being primarily exploratory or descriptive.
What does NIH mean here by an "extended" timeline?
In this context, an extended timeline means the clinical trial requires 6 or 7 years due to scientific and operational necessity. Examples mentioned include long-term follow-up to observe clinically meaningful outcomes, multi-site recruitment challenges, extended intervention delivery, or endpoints that naturally take years to develop.
What types of projects are not a good fit for this FOA?
This FOA is not intended for clinical trials that do not require a 6- or 7-year project period. If a trial can reasonably be completed within a typical project duration, this announcement is not the appropriate mechanism.
How important is the justification for a 6- or 7-year project period?
It is a key expectation. The FOA stresses that applicants should justify the extended timeline as a scientific and operational necessity, not simply as a preference.
Do applicants need to align with a specific NIH Institute or Center (IC)?
Yes. The trial topic, population, intervention, outcomes, and overall scientific purpose should fit within the priorities and statutory mission of an NIH Institute or Center that participates in this announcement.
Is it recommended to contact NIH program staff before applying?
Yes. Pre-submission consultation with NIH program staff is strongly encouraged to confirm IC fit and to clarify whether the proposed scope and timeline truly warrant a 6- or 7-year project period.
Why is pre-submission consultation with NIH program staff strongly encouraged?
Because it can help verify that the proposed project matches the intent of the FOA, confirm alignment with a participating IC, and reduce the risk of submitting an application that NIH views as mismatched to the announcement.
Who is eligible to apply?
The FOA is inclusive and allows applications from a wide range of organizations, including government entities, educational institutions, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, tribal governments and tribal organizations, and additional eligible entities listed in the announcement.
Which government entities are eligible?
Eligible government applicants include state governments, county governments, city or township governments, and special district governments. The FOA also includes eligible federal agencies among the additional eligible groups.
Are colleges and universities eligible to apply?
Yes. Eligible applicants include public and state-controlled institutions of higher education as well as private institutions of higher education. The FOA also highlights eligibility for specific institution types such as HBCUs, TCCUs, Hispanic-serving Institutions, and other serving institutions.
Are tribal entities eligible to apply?
Yes. The FOA includes federally recognized tribal governments and other tribal organizations. It also highlights Tribally Controlled Colleges and Universities (TCCUs) among additional eligible groups.
Are nonprofits eligible to apply?
Yes. Nonprofit organizations are eligible whether or not they have 501(c)(3) status.
Are for-profit organizations eligible to apply?
Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also eligible.
Are faith-based or community-based organizations eligible?
Yes. The FOA explicitly highlights faith-based or community-based organizations among additional eligible groups.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA includes non-U.S. (foreign) organizations among eligible applicants.
Are U.S. territories or possessions eligible to apply?
Yes. The FOA explicitly includes U.S. territories or possessions among additional eligible groups.
What funding instrument is used for this opportunity?
This opportunity uses the NIH R01 funding instrument (an NIH discretionary grant).
What is the funding activity category?
The funding activity category is Health.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed for this FOA are 93.855, 93.856, 93.859, and 93.866.
Is an award ceiling (maximum award amount) provided?
No award ceiling is specified in the provided information. This can be common for NIH FOAs where budgets may vary based on scientific merit, available funds, and NIH Institute/Center priorities.
Is the expected number of awards provided?
No expected number of awards is specified in the provided information.
When was this opportunity created and what closing date is shown?
The source information indicates the opportunity was created on 2016-11-17 and lists an original closing date of 2018-01-23.
What types of trial characteristics might support the need for 6 to 7 years?
Examples described include long recruitment timelines, extended follow-up requirements, outcome accrual that takes years to observe, multi-site operational complexity, extended intervention delivery, and endpoints that naturally require long observation periods.
What does "best-fit" look like for this FOA?
Best-fit applications describe a well-developed and rigorous clinical trial that is ready to run, provide a convincing rationale for why 6 to 7 years is essential, align clearly with a participating NIH IC mission, and demonstrate readiness to execute a complex trial over an extended period with appropriate oversight, staffing, and operational planning.
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