Opportunity Information: Apply for PAR 21 236
The NINDS Exploratory Clinical Trials funding opportunity (PAR-21-236) is a National Institutes of Health (NIH) program designed to support investigator-initiated, exploratory clinical trials that fall within the mission and research priorities of the National Institute of Neurological Disorders and Stroke (NINDS). The overall goal is to help researchers launch and run early-stage or exploratory human studies that answer important clinical questions in neurology and stroke, especially where the work can generate the kind of evidence needed to justify larger, later-phase trials. Projects proposed under this announcement need to be clearly aligned with NINDS interests, and applicants are expected to use the NINDS website as a guide for ensuring the proposed trial fits the institute's scope.
This opportunity uses the U01 mechanism, which is a cooperative agreement. In practical terms, that means the project is still led by the investigator, but NIH (and specifically NINDS program staff) typically have a more active role than they would under a standard research project grant. Cooperative agreements often involve substantial scientific or programmatic involvement from the funding institute during the life of the award, such as input on study milestones, oversight expectations, coordination requirements, or other elements meant to strengthen trial quality and accountability. The FOA is categorized as a discretionary funding opportunity and falls under the health funding activity category, with CFDA number 93.853.
The clinical trials supported by this FOA can evaluate a broad range of interventions relevant to neurological disorders and stroke. That includes drugs and other pharmacologic agents, biologics, and medical devices, as well as non-pharmacologic approaches such as surgical procedures, behavioral interventions, and rehabilitation therapies. The key idea is that these are exploratory trials, so the focus is commonly on questions like feasibility, initial safety signals, dose or parameter exploration, proof-of-concept, early evidence of target engagement, or preliminary clinical outcomes that can inform whether and how a larger definitive trial should proceed. Because it is explicitly labeled "Clinical Trial Required," applicants must be proposing a study that meets NIH's definition of a clinical trial, meaning there is prospective assignment to an intervention and an evaluation of effects on health-related biomedical or behavioral outcomes.
Eligibility is broad and includes many types of domestic organizations as well as certain non-domestic entities. Eligible applicants listed for this announcement include state, county, and local 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; Native American tribal organizations (other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofit organizations with 501(c)(3) status; nonprofits without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. In addition, the FOA explicitly highlights other eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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 even non-U.S. entities (foreign organizations). This range is intended to encourage broad participation across sectors and geographies, including institutions serving historically underrepresented communities.
From the source details provided, the FOA was created on 2021-05-07 and lists an original closing date of 2022-05-07. The award ceiling and expected number of awards were not specified in the provided excerpt, which generally means applicants would need to consult the full announcement and any linked NINDS guidance to understand typical budget expectations, recommended project scale, and the likely range of awards. Overall, the opportunity is best understood as a pathway for investigators to test promising interventions or strategies in human participants within neurology and stroke, with the structure and oversight of a U01 cooperative agreement to support rigorous, well-managed exploratory clinical trial execution.Apply for PAR 21 236
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials (U01 - Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
- This funding opportunity was created on 2021-05-07.
- Applicants must submit their applications by 2022-05-07. (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: NINDS Exploratory Clinical Trials (PAR-21-236)
What is the NINDS Exploratory Clinical Trials funding opportunity (PAR-21-236)?
PAR-21-236 is a National Institutes of Health (NIH) funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS). It supports investigator-initiated, exploratory clinical trials in humans that align with the NINDS mission and research priorities in neurology and stroke. The intent is to help teams launch and run early-stage clinical studies that answer important clinical questions and generate evidence needed to justify larger, later-phase trials.
What is the main purpose or goal of this FOA?
The main goal is to support early-stage or exploratory human studies that can provide the kind of data needed to decide whether, and how, to move forward to a larger definitive trial. These studies commonly address feasibility, early safety signals, dose or parameter exploration, proof-of-concept, target engagement, and preliminary clinical outcomes.
What NIH funding mechanism does this opportunity use?
This opportunity uses the U01 mechanism, which is a cooperative agreement.
What does it mean that this is a U01 cooperative agreement?
Under a cooperative agreement, the project is still led by the investigator, but NIH (specifically NINDS program staff) typically has a more active role than under a standard research project grant. That involvement can include input on study milestones, oversight expectations, coordination requirements, and other elements intended to strengthen trial quality and accountability during the award period.
Is a clinical trial required under this FOA?
Yes. The announcement is explicitly labeled "Clinical Trial Required," meaning applicants must propose a study that meets NIH's definition of a clinical trial.
What counts as a clinical trial for this opportunity (based on NIH's definition as described here)?
The proposed study must include prospective assignment to an intervention and an evaluation of the intervention's effects on health-related biomedical or behavioral outcomes.
What kinds of interventions can be evaluated in trials supported by this FOA?
The FOA supports a broad range of interventions relevant to neurological disorders and stroke, including drugs and other pharmacologic agents, biologics, medical devices, and non-pharmacologic approaches such as surgical procedures, behavioral interventions, and rehabilitation therapies.
What types of research questions are considered a good fit for an exploratory clinical trial under this FOA?
The emphasis is on exploratory, early-stage questions such as feasibility, initial safety signals, dose or parameter exploration, proof-of-concept, early evidence of target engagement, and preliminary clinical outcomes that can inform whether a larger definitive trial should proceed and how it should be designed.
What topic areas must the proposed trial address?
The proposed trial must fall within the mission and research priorities of NINDS and be clearly aligned with NINDS interests in neurology and stroke.
How can applicants determine whether their proposed trial aligns with NINDS priorities?
Applicants are expected to use the NINDS website as a guide to ensure the proposed trial fits within the institute's scope and interests.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations as well as certain non-domestic entities (foreign organizations). The eligible applicant types listed include:
- State, county, and local 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
- Native American tribal organizations (other than federally recognized tribal governments)
- Public housing authorities and Indian housing authorities
- Nonprofit organizations with 501(c)(3) status
- Nonprofits without 501(c)(3) status
- For-profit organizations other than small businesses
- Small businesses
Does the FOA specifically encourage participation from institutions serving underrepresented communities?
Yes. The FOA explicitly highlights additional eligible applicant categories that include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed among eligible applicant categories.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are listed as eligible.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The opportunity indicates that non-U.S. entities (foreign organizations) are eligible.
Is this a discretionary funding opportunity and what activity category does it fall under?
It is categorized as a discretionary funding opportunity and falls under the health funding activity category.
What is the CFDA number associated with this funding opportunity?
The CFDA number listed is 93.853.
When was this FOA created, and what is the closing date listed in the provided information?
Based on the provided source details, the FOA was created on 2021-05-07 and lists an original closing date of 2022-05-07.
Is the award ceiling provided in the excerpt?
No. The award ceiling was not specified in the provided excerpt.
Is the expected number of awards provided in the excerpt?
No. The expected number of awards was not specified in the provided excerpt.
What should applicants do if they need budget expectations or typical project scale information?
Because the excerpt does not include an award ceiling or expected number of awards, applicants would need to consult the full announcement and any linked NINDS guidance for information on typical budget expectations, recommended project scale, and the likely range of awards.
What is the overall takeaway for who this opportunity is best suited for?
This opportunity is best understood as a pathway for investigators to test promising interventions or strategies in human participants within neurology and stroke, using the structure and oversight of a U01 cooperative agreement to support rigorous, well-managed execution of exploratory clinical trials.
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Apply for PAR 21 236
Applicants also applied for:
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| Funding Opportunity |
|---|
| NIMH Exploratory/Developmental Research Grant (R21 Clinical Trial Not Allowed) Apply for PA 21 235 Funding Number: PA 21 235 Agency: National Institutes of Health Category: Health Funding Amount: $275,000 |
| Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional) Apply for PA 21 219 Funding Number: PA 21 219 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Emerging Science and Technology in Transplantation (U01 Clinical Trial Not Allowed) Apply for RFA AI 21 016 Funding Number: RFA AI 21 016 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| T32 Training Program for Institutions That Promote Diversity (T32 Clinical Trial Not Allowed) Apply for RFA HL 22 001 Funding Number: RFA HL 22 001 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required) Apply for PAR 21 237 Funding Number: PAR 21 237 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIH Directors New Innovator Award Program (DP2 Clinical Trial Optional) Apply for RFA RM 21 016 Funding Number: RFA RM 21 016 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| USAID Social and Behavior Change (SBC) MALARIA Program in Mozambique Apply for 72065621USAIDSBCMALARIA Funding Number: 72065621USAIDSBCMALARIA Agency: Mozambique USAID-Maputo Category: Health Funding Amount: $6,000,000 |
| Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) (D43 Clinical Trial Optional) Apply for PAR 21 230 Funding Number: PAR 21 230 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Adapting Immunotherapy and Gene Editing Based Strategies for Targeting HIV Reservoirs in the CNS: Potential Benefits and Risks (R01 Clinical Trial Optional) Apply for RFA MH 21 225 Funding Number: RFA MH 21 225 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Adapting Immunotherapy and Gene Editing Based Strategies for Targeting HIV Reservoirs in the CNS: Potential Benefits and Risks (R21 Clinical Trial Optional) Apply for RFA MH 21 226 Funding Number: RFA MH 21 226 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Mentored Career Development Award to Promote Faculty Diversity in Biomedical Research (K01 Independent Clinical Trial Required) Apply for RFA HL 22 010 Funding Number: RFA HL 22 010 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Mentored Career Development Award to Promote Faculty Diversity in Biomedical Research (K01 Independent Clinical Trial Not Allowed) Apply for RFA HL 22 011 Funding Number: RFA HL 22 011 Agency: National Institutes of Health Category: Health Funding Amount: $150,000 |
| NIA Postdoctoral Fellowship Award to Promote Diversity in Translational Research for AD/ADRD (F32 Clinical Trial Not Allowed) Apply for PAR 21 217 Funding Number: PAR 21 217 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIA Advanced Postdoctoral Career Transition Awards to Promote Diversity in Translational Research for AD/ADRD (K99/R00 Clinical Trial Not Allowed) Apply for PAR 21 220 Funding Number: PAR 21 220 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIA Predoctoral Fellowship Award to Promote Diversity in Translational Research for AD/ADRD (F31) Apply for PAR 21 218 Funding Number: PAR 21 218 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), Diagnostic-Telemedicine Resource (U24 Clinical Trial Not Allowed) Apply for RFA AA 21 012 Funding Number: RFA AA 21 012 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), Developmental Project (UH2 Clinical Trial Optional) Apply for RFA AA 21 014 Funding Number: RFA AA 21 014 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), Data Coordination Resource (U24 Clinical Trial Not Allowed) Apply for RFA AA 21 013 Funding Number: RFA AA 21 013 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), Administrative Resource (U24) (Clinical Trial Not Allowed) Apply for RFA AA 21 011 Funding Number: RFA AA 21 011 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), Research Project (U01 Clinical Trial optional) Apply for RFA AA 21 010 Funding Number: RFA AA 21 010 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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