Opportunity Information: Apply for PAR 19 060
The NINR Clinical Trial Planning Grant (R34 Clinical Trial Required), funding opportunity number PAR-19-060, is a discretionary NIH grant designed to give research teams dedicated time and resources to fully plan an investigator-initiated clinical trial that aligns closely with the mission of the National Institute of Nursing Research (NINR). The central aim is not to fund the full-scale clinical trial itself, but to support the work that needs to happen before a larger trial can responsibly launch, including refining the research questions, locking down key design decisions, and building the operational roadmap for how the trial will actually be carried out.
A defining expectation of this R34 is that the planning period includes feasibility and pilot work that directly informs whether the proposed intervention and trial approach are viable. In practice, that means award-supported activities should help answer real-world questions such as whether recruitment strategies will work, whether participants will accept and adhere to the intervention, whether study procedures are practical in the intended settings, and whether the measurement plan is workable and sensitive enough. These feasibility or pilot activities are intended to reduce risk and uncertainty before a larger, more expensive clinical trial is proposed, and to produce concrete evidence that the intervention and trial methods can be implemented as planned.
The opportunity is categorized under Education and Health and is administered by the National Institutes of Health under CFDA 93.361. It uses the grant funding instrument. The listed award ceiling is $150,000, indicating a modest budget consistent with planning, early testing, and trial-preparation tasks rather than full trial execution. The FOA record notes an original closing date of July 16, 2020, and a creation date of November 7, 2018, which situates it as an established NIH mechanism for trial planning within the NINR portfolio.
Eligibility is broad and includes a wide range of domestic organizations and several special categories that often align with community-based research and workforce development. Standard eligible applicants include state, county, city or township, and 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; public housing authorities and Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; and small businesses. In addition, the FOA explicitly highlights other eligible applicant 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, Indian/Native American tribal governments other than federally recognized entities, and even non-domestic (non-U.S.) entities (foreign organizations). Taken together, this eligibility scope supports planning efforts that may involve academic medical centers, nursing schools, community organizations, tribal partners, and international collaborators when appropriate.
Overall, this FOA is best understood as a structured “trial-readiness” grant from NINR: it supports teams in doing the preparatory scientific and operational work needed to confidently move into a subsequent, fully powered clinical trial application. The required planning activities, especially feasibility and pilot studies, are meant to strengthen the rationale and execution plan so that the next-stage clinical trial is both methodologically sound and realistically implementable in the settings and populations the research intends to serve.Apply for PAR 19 060
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "NINR Clinical Trial Planning Grant (R34 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.361.
- This funding opportunity was created on 2018-11-07.
- Applicants must submit their applications by 2020-07-16. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- 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): NINR Clinical Trial Planning Grant (R34 Clinical Trial Required) - PAR-19-060
What is the NINR Clinical Trial Planning Grant (R34 Clinical Trial Required)?
PAR-19-060 is a discretionary NIH funding opportunity from the National Institute of Nursing Research (NINR) that provides time and resources for research teams to fully plan an investigator-initiated clinical trial that closely aligns with the NINR mission. The focus is on trial planning and readiness activities rather than running the full-scale clinical trial.
What is the main purpose of this grant opportunity?
The main purpose is to support the pre-trial work needed to responsibly launch a future, larger clinical trial. This includes refining the research questions, making and confirming key study design choices, and developing an operational roadmap for how the trial will be conducted.
Does this grant fund the full clinical trial?
No. The central aim is not to fund the full-scale clinical trial itself, but to fund the planning and preparatory work that should happen before a larger trial is proposed and launched.
What kinds of activities are expected during the planning period?
The planning period is expected to include scientific and operational preparation, such as refining research questions, finalizing trial design decisions, and developing practical plans for implementation. A defining expectation is that the planning period also includes feasibility and pilot work that directly informs trial viability.
Are feasibility and pilot studies required or just encouraged?
They are an explicit expectation of this R34 planning grant. The award-supported planning period is expected to include feasibility and pilot work that helps determine whether the proposed intervention and trial approach are viable.
What real-world questions should feasibility or pilot work help answer?
Feasibility and pilot activities should help reduce uncertainty by testing whether key trial elements are workable. Examples described in the opportunity include whether recruitment strategies will work, whether participants will accept and adhere to the intervention, whether study procedures are practical in the intended settings, and whether the measurement plan is workable and sensitive enough.
Why does the FOA emphasize feasibility and pilot work?
The intent is to reduce risk before a larger, more expensive clinical trial is proposed. The planning grant is meant to produce concrete evidence that the intervention and trial methods can be implemented as planned and that the approach is realistic for the settings and populations of interest.
What is meant by a "trial-readiness" grant?
In this context, "trial-readiness" means the grant supports the preparatory scientific and operational steps needed to move confidently into a subsequent, fully powered clinical trial application. It is designed to strengthen both the rationale and the execution plan for the next-stage trial.
Who administers this funding opportunity?
The opportunity is administered by the National Institutes of Health (NIH), specifically within the portfolio of the National Institute of Nursing Research (NINR).
What is the funding opportunity number for this grant?
The funding opportunity number is PAR-19-060.
What category is this opportunity listed under?
The opportunity is categorized under Education and Health.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.361.
What funding instrument does the opportunity use?
It uses the grant funding instrument.
What is the maximum award amount (award ceiling)?
The listed award ceiling is $150,000, which reflects a modest budget intended for planning, early testing, and trial-preparation work rather than full trial execution.
What does the $150,000 award ceiling suggest about the scope of work?
It suggests the project should be scoped to planning and feasibility/pilot activities that directly inform readiness for a future clinical trial, rather than activities associated with conducting a full, large-scale trial.
When was this FOA created?
The FOA record notes a creation date of November 7, 2018.
What is the closing date listed for this opportunity?
The FOA record notes an original closing date of July 16, 2020.
Who is eligible to apply?
Eligibility is broad and includes many domestic organization types as well as special categories and non-domestic entities. Eligible applicants include state, county, city or township, and 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; public housing authorities and Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; and small businesses.
Are minority-serving institutions included in the eligibility list?
Yes. The FOA explicitly highlights 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 related institution types.
Can faith-based or community-based organizations apply?
Yes. Faith-based or community-based organizations are explicitly highlighted as eligible applicant types.
Can federal agencies apply?
Yes. Eligible federal agencies are explicitly listed among the other eligible applicant types.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly included in the highlighted eligibility list.
Are tribal entities eligible even if they are not federally recognized?
Yes. The eligibility list includes Indian/Native American tribal governments other than federally recognized entities, and also includes Native American tribal organizations other than federally recognized tribal governments.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA includes non-domestic (non-U.S.) entities (foreign organizations) in its eligibility scope.
What types of organizations does this broad eligibility support in practice?
The stated scope supports planning efforts that may involve academic medical centers, nursing schools, community organizations, tribal partners, and international collaborators when appropriate.
What should the planning work produce by the end of the award?
Based on the FOA description, planning activities should result in concrete evidence and a clearer, more implementable plan indicating whether recruitment, intervention delivery and adherence, procedures in intended settings, and the measurement approach are viable for a subsequent larger clinical trial application.
How should applicants think about alignment with NINR?
The opportunity is intended for investigator-initiated clinical trial planning that aligns closely with the mission of the National Institute of Nursing Research (NINR). The planned trial and the preparatory work should fit within the NINR mission focus as described in the opportunity summary.
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| Mechanism for Time-Sensitive Drug Abuse Research (R21 Clinical Trial Optional) Apply for PAR 19 064 Funding Number: PAR 19 064 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Implementation Science for Cancer Control: Advanced Centers (P50 Clinical Trial Optional) Apply for RFA CA 19 006 Funding Number: RFA CA 19 006 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,200,000 |
| Implementation Science for Cancer Control: Developing Centers (P50 Clinical Trial Optional) Apply for RFA CA 19 005 Funding Number: RFA CA 19 005 Agency: National Institutes of Health Category: Education, Health Funding Amount: $600,000 |
| Telomeres in Wellness and Disease: A Biobehavioral Approach (R01 Clinical Trial Optional) Apply for PA 19 074 Funding Number: PA 19 074 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Data Science Research: Personal Health Libraries for Consumers and Patients (R01 Clinical Trial Optional) Apply for PAR 19 072 Funding Number: PAR 19 072 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| Telomeres in Wellness and Disease: A Biobehavioral Approach (R21 Clinical Trial Optional) Apply for PA 19 073 Funding Number: PA 19 073 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Independent Scientist Award (Parent K02 - Independent Basic Experimental Studies with Humans Required) Apply for PA 19 085 Funding Number: PA 19 085 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Leveraging Health Information Technology (Health IT) to Address Minority Health and Health Disparities (R01 Clinical Trial Optional) Apply for PAR 19 093 Funding Number: PAR 19 093 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Epidemic (R43/R44 - Clinical Trial Optional) Apply for RFA DA 19 019 Funding Number: RFA DA 19 019 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Epidemic (R41/R42 - Clinical Trial Optional) Apply for RFA DA 19 020 Funding Number: RFA DA 19 020 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional) Apply for RFA DA 19 025 Funding Number: RFA DA 19 025 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,500,000 |
| HEAL Initiative Limited Competition: Behavioral Research to Improve MAT: Ancillary Studies to Enhance Behavioral or Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R01, Clinical Trials Optional) Apply for RFA AT 19 007 Funding Number: RFA AT 19 007 Agency: National Institutes of Health Category: Education, Health Funding Amount: $400,000 |
| HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional) Apply for RFA HL 19 029 Funding Number: RFA HL 19 029 Agency: National Institutes of Health Category: Education, Health Funding Amount: $750,000 |
| HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required) Apply for RFA MH 19 525 Funding Number: RFA MH 19 525 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed) Apply for RFA HL 19 028 Funding Number: RFA HL 19 028 Agency: National Institutes of Health Category: Education, Health Funding Amount: $350,000 |
| Physical Sciences-Oncology Network (PS-ON): Physical Sciences-Oncology Projects (PS-OP) (U01 Clinical Trial Optional) Apply for PAR 19 101 Funding Number: PAR 19 101 Agency: National Institutes of Health Category: Education, Health Funding Amount: $499,999 |
| Cancer Tissue Engineering Collaborative: Enabling Biomimetic Tissue-Engineered Technologies for Cancer Research (R01 Clinical Trial Optional) Apply for PAR 19 113 Funding Number: PAR 19 113 Agency: National Institutes of Health Category: Education, Health Funding Amount: $400,000 |
| Improving Outcomes in Cancer Treatment-Related Cardiotoxicity (R21 Clinical Trial Optional) Apply for PA 19 111 Funding Number: PA 19 111 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Improving Outcomes in Cancer Treatment-Related Cardiotoxicity (R01 Clinical Trial Optional) Apply for PA 19 112 Funding Number: PA 19 112 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NIH Pathway to Independence Award (Parent K99/R00 - Independent Clinical Trial Not Allowed) Apply for PA 19 130 Funding Number: PA 19 130 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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