Opportunity Information: Apply for PA 18 345
The NIH Research Project Grant (Parent R01 Clinical Trial Required), funding opportunity number PA 18-345, is a National Institutes of Health discretionary grant designed to support a discrete, well-defined research project that fits the scientific expertise of the investigator(s) and aligns with the mission interests of one or more participating NIH Institutes and Centers (ICs). This is a "Parent" R01 announcement, meaning it serves as a broad entry point for investigator-initiated projects across many biomedical, behavioral, clinical, and related research areas, as long as the work clearly maps to an NIH IC's programmatic priorities. The key requirement that sets this particular parent announcement apart is that the application must include at least one clinical trial as part of the proposed research.
Because NIH uses a specific definition of a clinical trial, applicants need to be careful to ensure their study meets that definition and is described accordingly. A central point in the announcement is that some participating ICs will only accept applications through this mechanism when the proposed clinical trial is mechanistic in nature, meaning the trial is intended to understand biological, behavioral, or physiological mechanisms rather than primarily to establish clinical efficacy or effectiveness. The announcement directs applicants to pay close attention to "Related Notices" from specific ICs, since individual NIH components may place additional limits or preferences on what kinds of clinical trials they will accept under this FOA. In practice, that means applicants should confirm early that their trial type, endpoints, and overall aims are a good fit for the IC(s) they plan to target.
Eligibility is broad and includes many types of domestic U.S. organizations and governments, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; and public housing authorities/Indian housing authorities. The opportunity is also open to federally recognized Native American tribal governments, as well as Native American tribal organizations that are not federally recognized tribal governments. In addition, both nonprofit organizations (with or without 501(c)(3) status) and for-profit organizations (other than small businesses), as well as small businesses, may apply. The announcement also explicitly calls out additional eligible applicant categories, including 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, and eligible federal agencies. Notably, non-U.S. entities (foreign organizations), regional organizations, and U.S. territories or possessions are also listed among eligible applicants, reflecting NIH's openness to high-value clinical research collaborations and projects that may require international or territorial settings.
The sponsoring agency is NIH, and the funding activity category is listed under Education, Environment, and Health, with multiple CFDA numbers associated with NIH programs (including 93.113, 93.172, 93.213, 93.233, 93.273, 93.279, 93.307, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.855, 93.859, and 93.866), which signals that the parent announcement is used across a wide range of NIH institutes and scientific topics. The record shows a creation date of November 3, 2017, and an original closing date of January 7, 2019, as captured in the source information provided. The award ceiling and expected number of awards are not specified in the supplied data, which is common in NIH parent announcements because budgets and award counts vary by institute, fiscal year, application volume, and the availability of appropriated funds.
Overall, this opportunity is best understood as NIH's standard R01 mechanism for investigator-initiated projects where a clinical trial is not optional but required. Applicants are expected to propose a focused project with strong scientific rationale, a design appropriate for a clinical trial under NIH rules, and a clear fit with at least one NIH IC's mission, while also checking institute-specific policies that may narrow what kinds of trials can be submitted through this particular parent announcement.Apply for PA 18 345
- The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "NIH Research Project Grant (Parent R01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.172, 93.213, 93.233, 93.273, 93.279, 93.307, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.855, 93.859, 93.866.
- This funding opportunity was created on 2017-11-03.
- Applicants must submit their applications by 2019-01-07. (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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FAQs: NIH Research Project Grant (Parent R01 Clinical Trial Required) - PA 18-345
What is this funding opportunity?
This opportunity is the NIH Research Project Grant (Parent R01 Clinical Trial Required), funding opportunity number PA 18-345. It is an NIH discretionary grant intended to support a discrete, well-defined research project that matches the scientific expertise of the investigator(s) and aligns with the mission interests of one or more participating NIH Institutes and Centers (ICs).
What does it mean that this is a "Parent" R01 announcement?
"Parent" R01 means the announcement is designed as a broad entry point for investigator-initiated projects across many biomedical, behavioral, clinical, and related research areas. Projects are eligible as long as the proposed work clearly maps to an NIH IC's programmatic priorities.
Is a clinical trial optional under PA 18-345?
No. The defining requirement of this parent announcement is that the application must include at least one clinical trial as part of the proposed research.
What should applicants consider about NIH's definition of a clinical trial?
NIH uses a specific definition of a clinical trial, and applicants need to ensure their study meets that definition and is described accordingly in the application. The announcement emphasizes being careful and precise about whether the proposed study qualifies as a clinical trial under NIH rules.
Do all NIH Institutes and Centers accept all types of clinical trials under this FOA?
Not necessarily. The announcement notes that some participating ICs will only accept applications through this mechanism when the proposed clinical trial is mechanistic in nature. Applicants are directed to pay close attention to "Related Notices" from specific ICs because individual NIH components may impose additional limits or preferences on the kinds of clinical trials they will accept under this FOA.
What is a "mechanistic" clinical trial in the context of this announcement?
In this FOA, a mechanistic trial is described as a clinical trial intended to understand biological, behavioral, or physiological mechanisms, rather than being primarily designed to establish clinical efficacy or effectiveness.
Why is it important to check "Related Notices" from NIH Institutes and Centers?
Because institute-specific notices may add constraints or preferences beyond the parent announcement, including limitations on trial type. The FOA highlights that applicants should confirm early that their trial type, endpoints, and overall aims fit the NIH IC they plan to target.
What kinds of projects are a good fit for this R01?
A good fit is a focused, well-defined investigator-initiated research project with a strong scientific rationale, a design appropriate for a clinical trial under NIH rules, and a clear alignment with at least one participating NIH IC's mission and program priorities.
Who is eligible to apply?
Eligibility is broad. The FOA lists many eligible applicants, including domestic U.S. organizations and governments; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; eligible federal agencies; and additional categories of institutions and organizations explicitly named in the opportunity.
Are state, county, and local governments eligible?
Yes. Eligible applicants include state, county, and local governments, as well as special district governments.
Are public and private higher education institutions eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education as well as private institutions of higher education.
Are independent school districts eligible?
Yes. Independent school districts are listed among eligible applicant types.
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
Are Native American tribal governments eligible?
Yes. Federally recognized Native American tribal governments are eligible under this opportunity.
Are Native American tribal organizations that are not federally recognized eligible?
Yes. The opportunity also lists Native American tribal organizations that are not federally recognized tribal governments as eligible.
Are nonprofit organizations eligible even if they do not have 501(c)(3) status?
Yes. The FOA includes nonprofit organizations with or without 501(c)(3) status.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible applicants.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly called out among eligible applicant categories.
Are minority-serving institutions specifically included as eligible applicants?
Yes. The FOA explicitly includes multiple institution types 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), and other named categories.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. entities (foreign organizations) are listed among eligible applicants, reflecting NIH's openness to projects that may require international settings or collaborations.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed among eligible applicants.
Are regional organizations eligible?
Yes. Regional organizations are included among the eligible applicant categories.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the funding activity category listed for this opportunity?
The funding activity category is listed under Education, Environment, and Health.
What do the multiple CFDA numbers indicate?
The presence of multiple CFDA numbers (including 93.113, 93.172, 93.213, 93.233, 93.273, 93.279, 93.307, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.855, 93.859, and 93.866) signals that this parent announcement is used across a wide range of NIH institutes and scientific topics.
When was this opportunity created, and what closing date is shown in the provided record?
The provided record shows a creation date of November 3, 2017, and an original closing date of January 7, 2019.
Is there an award ceiling listed? Is the expected number of awards specified?
No. The award ceiling and expected number of awards are not specified in the supplied information. This is described as common for NIH parent announcements because budgets and award counts can vary by institute, fiscal year, application volume, and the availability of appropriated funds.
What is the main takeaway about how to approach this FOA?
This is NIH's standard R01 mechanism for investigator-initiated projects where a clinical trial is required. Applicants should propose a focused project with a strong rationale and a clinical trial design that fits NIH rules, clearly align the work to an NIH IC's mission, and verify institute-specific policies (including whether only mechanistic trials are accepted) by reviewing relevant IC notices early in the process.
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| Research to Action: Assessing and Addressing Community Exposures to Environmental Contaminants (R01 Clinical Trial Optional) Apply for PA 18 260 Funding Number: PA 18 260 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
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| Environmental Exposures and Health: Exploration of Non-Traditional Settings (R21 Clinical Trial Optional) Apply for PA 18 160 Funding Number: PA 18 160 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
| Environmental Exposures and Health: Exploration of Non-Traditional Settings (R01 Clinical Trial Optional) Apply for PA 18 142 Funding Number: PA 18 142 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Independent Scientist Award (Parent K02 - Independent Clinical Trials Not Allowed) Apply for PA 18 371 Funding Number: PA 18 371 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Midcareer Investigator Award in Patient-Oriented Research (Parent K24 - No Independent Clinical Trials) Apply for PA 18 394 Funding Number: PA 18 394 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| NIH Exploratory/Developmental Research Grant Program ( Parent R21 Clinical Trial Not Allowed) Apply for PA 18 489 Funding Number: PA 18 489 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
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| Innovative Basic Research on Adducts in Cancer Risk Identification and Prevention (R21 Clinical Trial Not Allowed) Apply for PAR 18 703 Funding Number: PAR 18 703 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
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| Electronic Nicotine Delivery Systems (ENDS): Basic Mechanisms of Health Effects (R21 - Clinical Trial Not Allowed) Apply for PAR 18 846 Funding Number: PAR 18 846 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Superfund Hazardous Substance Research and Training Program (P42 Clinical Trial Optional) Apply for RFA ES 18 002 Funding Number: RFA ES 18 002 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $1,750,000 |
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| Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01 Clinical Trial Not Allowed) Apply for PAR 19 039 Funding Number: PAR 19 039 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $300,000 |
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| Promoting Research on Music and Health: Fundamentals and Applications (R21 Clinical Trials Optional) Apply for RFA NS 19 009 Funding Number: RFA NS 19 009 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Immuno-Oncology Translation Network (IOTN): Cancer Immunoprevention Research Projects (UG3/UH3) Apply for RFA CA 19 012 Funding Number: RFA CA 19 012 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $500,000 |
| Emerging Global Leader Award (K43 Independent Clinical Trial Required) Apply for PAR 19 051 Funding Number: PAR 19 051 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Research Project Grant (Parent R01 Clinical Trial Required) Apply for PA 19 055 Funding Number: PA 19 055 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
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