Opportunity Information: Apply for PA 18 484

The NIH Research Project Grant (Parent R01, Clinical Trial Not Allowed) is a long-running National Institutes of Health (NIH) funding mechanism designed to support a clearly defined, standalone research project proposed and led by one or more investigators. The central purpose of this opportunity is to fund hypothesis-driven or problem-focused biomedical, behavioral, clinical, or health-related research that fits within the scientific mission and program priorities of at least one participating NIH Institute or Center. In practical terms, applicants are expected to propose a project with a well-scoped set of aims, a strong scientific rationale, and an approach that can be carried out within the proposed budget and project period, with the investigator team bringing the expertise needed to execute the work successfully.

A key restriction in this particular funding announcement is that it does not accept clinical trials. That means applicants must ensure the proposed research does not include prospective assignment of human participants to an intervention (or comparison group) to study the effects of that intervention on health-related outcomes. Projects involving human data or human participants may still be possible depending on the details, but anything that meets NIH's definition of a clinical trial would be considered nonresponsive under this announcement and should instead be routed to an NIH opportunity that explicitly allows clinical trials. This is an important compliance point because a clinical-trial element can make an otherwise strong application ineligible.

The opportunity is issued by NIH as a discretionary grant program and is identified by Funding Opportunity Number PA-18-484, titled "NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)." It is tied to a broad set of CFDA numbers (now commonly referenced through Assistance Listing numbers) spanning many NIH Institutes and Centers, reflecting that it is a "parent" announcement meant to accommodate many scientific areas rather than a single targeted topic. Because it is a parent R01, it generally serves as an entry point for investigator-initiated research ideas, with applicants selecting an NIH Institute or Center assignment aligned with the proposed science.

Eligibility is broad and includes many types of domestic organizations and, notably, certain non-U.S. entities. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicants 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-domestic (non-U.S.) entities (foreign organizations). This wide eligibility is meant to ensure that strong research ideas can come from many sectors and institutional settings, not only traditional academic medical centers.

From the administrative details provided, the opportunity was created on 2017-12-06, with an original closing date shown as 2019-01-07. The listing does not specify an award ceiling or expected number of awards in the provided data, which is common for NIH parent announcements because award size and volume vary by Institute/Center budgets, program priorities, and the scientific merit of submitted applications. In effect, applicants should plan budgets that are appropriate and well-justified for the scope of work and consistent with NIH R01 norms and any Institute-specific guidance, rather than expecting a fixed maximum stated in the announcement summary.

Overall, this opportunity is best understood as NIH's primary pathway for investigator-initiated, non-clinical-trial research projects that are discrete, well-scoped, and aligned with NIH mission areas. Applicants who can articulate a compelling scientific question, propose rigorous methods, and demonstrate the team and environment needed to complete the work, while staying clearly outside the clinical trial definition, are the best fit for this funding announcement.

  • The National Institutes of Health in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879.
  • This funding opportunity was created on 2017-12-06.
  • 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.
Apply for PA 18 484

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FAQs: NIH Research Project Grant (Parent R01, Clinical Trial Not Allowed) - PA-18-484

What is this funding opportunity?

This opportunity is the NIH Research Project Grant (Parent R01, Clinical Trial Not Allowed). It supports a clearly defined, standalone research project proposed and led by one or more investigators. The intent is to fund hypothesis-driven or problem-focused biomedical, behavioral, clinical, or other health-related research that aligns with the mission and program priorities of at least one participating NIH Institute or Center.

What is the Funding Opportunity Number (FOA) and title?

The Funding Opportunity Number is PA-18-484. The title is "NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)."

What does "Parent R01" mean in practical terms?

"Parent R01" refers to a broad, investigator-initiated NIH announcement that can accommodate many scientific areas rather than a single targeted topic. Applicants typically propose their own research idea and select an NIH Institute or Center assignment that best fits the proposed science.

What types of research does this opportunity support?

It supports hypothesis-driven or problem-focused research in biomedical, behavioral, clinical, or health-related areas, as long as the work fits within the mission and program priorities of a participating NIH Institute or Center. Applications are expected to present a well-scoped set of aims, a strong scientific rationale, and an approach that can be completed within the proposed budget and project period.

Does this FOA allow clinical trials?

No. This announcement does not accept clinical trials. A proposal that includes a clinical-trial element would be considered nonresponsive under this announcement and should instead be submitted to an NIH opportunity that explicitly allows clinical trials.

How does NIH define a clinical trial for purposes of this restriction?

In this context, a clinical trial involves prospective assignment of human participants to an intervention (or a comparison group) to study the effects of that intervention on health-related outcomes. If a project meets that definition, it would not be eligible under this "Clinical Trial Not Allowed" parent R01 announcement.

Can a project involve human participants or human data if it is not a clinical trial?

Possibly. The information provided indicates that projects involving human data or human participants may still be feasible depending on the details, but applicants must ensure the proposed research does not meet NIH's definition of a clinical trial.

Why is the "no clinical trials" rule so important?

Because it is a compliance and eligibility issue. Even an otherwise strong application can become ineligible if it includes a clinical-trial component under NIH's definition. Applicants are expected to confirm that their project stays clearly outside the clinical trial definition for this FOA.

Who is eligible to apply?

Eligibility is broad and includes many domestic organization types and certain non-U.S. entities. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.

Are foreign (non-U.S.) organizations eligible to apply?

Yes. The provided information explicitly includes non-domestic (non-U.S.) entities (foreign organizations) as eligible applicants.

Are federally recognized tribal governments and other tribal organizations eligible?

Yes. The eligible applicants list includes federally recognized Native American tribal governments and also tribal organizations other than federally recognized tribal governments.

Are nonprofits and for-profits eligible?

Yes. Eligible applicants include nonprofits with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations other than small businesses, and small businesses.

Are higher education institutions eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.

Are government entities eligible to apply?

Yes. The eligibility list includes state, county, and city or township governments, as well as special district governments and independent school districts.

Are there additional categories of organizations specifically highlighted as eligible?

Yes. The opportunity also highlights additional eligible applicants 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, and U.S. territories or possessions.

Is this considered a discretionary grant program?

Yes. The opportunity is issued by NIH as a discretionary grant program.

What CFDA or Assistance Listing numbers are associated with this opportunity?

The opportunity is tied to a broad set of CFDA numbers (now commonly referenced through Assistance Listing numbers) spanning many NIH Institutes and Centers. This reflects that it is a parent announcement intended to support many scientific areas rather than a single topic area.

How should applicants think about Institute or Center alignment?

Because this is a parent announcement, applicants are expected to align their proposed science with the mission and program priorities of at least one participating NIH Institute or Center, and to select an Institute or Center assignment that matches the research.

What kind of project structure is NIH looking for under this R01?

Based on the provided information, NIH expects a well-scoped set of aims, a strong scientific rationale, and a feasible approach that can be completed within the proposed budget and project period. The investigator team should bring the expertise needed to execute the work successfully.

Does the listing specify an award ceiling or the expected number of awards?

No. The provided data does not specify an award ceiling or the expected number of awards. The description notes this is common for NIH parent announcements because award size and volume vary by Institute or Center budgets, program priorities, and the scientific merit of submitted applications.

How should budgets be planned if there is no stated award ceiling?

Applicants should plan a budget that is appropriate and well-justified for the proposed scope of work, and consistent with NIH R01 norms and any Institute-specific guidance, rather than relying on a fixed maximum stated in the announcement summary.

When was this opportunity created, and what closing date is shown?

The opportunity was created on 2017-12-06. The listing shows an original closing date of 2019-01-07.

What kinds of applicants are the best fit for this FOA?

Based on the information provided, the best fit are applicants proposing discrete, well-scoped, investigator-initiated research projects that align with NIH mission areas and clearly avoid the clinical trial definition. Strong fit applications typically articulate a compelling scientific question, use rigorous methods, and demonstrate the team and environment needed to complete the work.

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Applicants also applied for:

Applicants who have applied for this opportunity (PA 18 484) also looked into and applied for these:

Funding Opportunity
Academic Research Enhancement Award (Parent R15 Clinical Trial Not Allowed) Apply for PA 18 504

Funding Number: PA 18 504
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: $300,000
Innovation Corps (I-Corps) at NIH Program for NIH and CDC Translational Research (Admin Supp - Clinical Trial Not Allowed) Apply for PA 18 517

Funding Number: PA 18 517
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) Apply for PA 18 574

Funding Number: PA 18 574
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) Apply for PA 18 575

Funding Number: PA 18 575
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed) Apply for PA 18 586

Funding Number: PA 18 586
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp - Clinical Trial Optional) Apply for PA 18 591

Funding Number: PA 18 591
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Successor-in-Interest (Type 6 Parent Clinical Trial Optional) Apply for PA 18 589

Funding Number: PA 18 589
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Change of Grantee Organization (Type 7 Parent Clinical Trial Optional) Apply for PA 18 590

Funding Number: PA 18 590
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp - Clinical Trial Not Allowed ) Apply for PA 18 592

Funding Number: PA 18 592
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed) Apply for PA 18 648

Funding Number: PA 18 648
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Administrative Supplement for Research on Sex/Gender Influences (Admin Supp - Clinical Trial Optional) Apply for PA 18 658

Funding Number: PA 18 658
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31) Apply for PA 18 666

Funding Number: PA 18 666
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions with NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) Apply for PA 18 668

Funding Number: PA 18 668
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31) Apply for PA 18 671

Funding Number: PA 18 671
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32) Apply for PA 18 670

Funding Number: PA 18 670
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Ruth L. Kirschstein National Research Service Award (NRSA)Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) Apply for PA 18 673

Funding Number: PA 18 673
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Lasker Clinical Research Scholars Program (Si2/R00 Clinical Trial Optional) Apply for PAR 18 740

Funding Number: PAR 18 740
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Administrative Supplements for Research on Dietary Supplements (Admin. Supp.- Clinical Trial Not Allowed) Apply for PA 18 817

Funding Number: PA 18 817
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: $100,000
Research Project Grant (Parent R01 Clinical Trial Not Allowed) Apply for PA 19 056

Funding Number: PA 19 056
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required) Apply for PA 19 116

Funding Number: PA 19 116
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent

 

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