This grant opportunity supports investigator-initiated clinical trials designed for extended project periods of six or seven years. Applications are invited for hypothesis-driven trials, which can be in any phase, provided they align directly with the research mission of the participating Institutes and Centers (ICs). Prospective applicants are strongly encouraged to consult with relevant IC staff prior to submitting their clinical trial implementation applications to ensure alignment and strengthen proposals. This funding is specifically designed for comprehensive trials necessitating a longer duration for completion, and it is not intended for projects that do not require such an extended timeframe. The initiative aims to foster significant advancements through in-depth, long-term clinical investigations.
Opportunity ID: 345365
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-23-084 |
| Funding Opportunity Title: | Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 12, 2023 |
| Last Updated Date: | May 15, 2025 |
| Original Closing Date for Applications: | Jan 13, 2026 |
| Current Closing Date for Applications: | May 23, 2025 |
| Archive Date: | Jun 22, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities For profit organizations other than small businesses County governments State governments Small businesses Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) 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 |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) invites applications for implementation of investigator-initiated clinical trials requiring an extended project period of 6 or 7 years. The trials can be any phase, must be hypothesis-driven, and related to the research mission of the participating IC. Consultation with IC staff is strongly encouraged prior to the submission of the clinical trial implementation application. This FOA is not intended for support of clinical trials that do not require an extended project period of 6 or 7 years. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-23-084.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Update close date per NOT-OD-25-113. | May 15, 2025 | |
| Jan 12, 2023 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-23-084 |
| Funding Opportunity Title: | Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 12, 2023 |
| Last Updated Date: | May 15, 2025 |
| Original Closing Date for Applications: | Jan 13, 2026 |
| Current Closing Date for Applications: | May 23, 2025 |
| Archive Date: | Jun 22, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities For profit organizations other than small businesses County governments State governments Small businesses Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) 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 |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) invites applications for implementation of investigator-initiated clinical trials requiring an extended project period of 6 or 7 years. The trials can be any phase, must be hypothesis-driven, and related to the research mission of the participating IC. Consultation with IC staff is strongly encouraged prior to the submission of the clinical trial implementation application. This FOA is not intended for support of clinical trials that do not require an extended project period of 6 or 7 years. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-23-084.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-23-084 |
| Funding Opportunity Title: | Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 12, 2023 |
| Last Updated Date: | Jan 12, 2023 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 13, 2026 |
| Archive Date: | Feb 18, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Special district governments Native American tribal governments (Federally recognized) 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 Small businesses Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Independent school districts Private institutions of higher education City or township governments Public and State controlled institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) invites applications for implementation of investigator-initiated clinical trials requiring an extended project period of 6 or 7 years. The trials can be any phase, must be hypothesis-driven, and related to the research mission of the participating IC. Consultation with IC staff is strongly encouraged prior to the submission of the clinical trial implementation application. This FOA is not intended for support of clinical trials that do not require an extended project period of 6 or 7 years. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-23-084.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or before January 24, 2025 | PKG00279224 | Apr 13, 2023 | Jan 24, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288582 | Nov 07, 2024 | May 23, 2025 | View |
Package 1
Mandatory forms
345365 RR_SF424_5_0-5.0.pdf
345365 PHS398_CoverPageSupplement_5_0-5.0.pdf
345365 RR_OtherProjectInfo_1_4-1.4.pdf
345365 PerformanceSite_4_0-4.0.pdf
345365 RR_KeyPersonExpanded_4_0-4.0.pdf
345365 RR_Budget10_3_0-3.0.pdf
345365 PHS398_ResearchPlan_5_0-5.0.pdf
345365 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
345365 RR_SubawardBudget10_30_3_0-3.0.pdf
345365 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
345365 RR_SF424_5_0-5.0.pdf
345365 PHS398_CoverPageSupplement_5_0-5.0.pdf
345365 RR_OtherProjectInfo_1_4-1.4.pdf
345365 PerformanceSite_4_0-4.0.pdf
345365 RR_KeyPersonExpanded_4_0-4.0.pdf
345365 RR_Budget10_3_0-3.0.pdf
345365 PHS398_ResearchPlan_5_0-5.0.pdf
345365 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
345365 RR_SubawardBudget10_30_3_0-3.0.pdf
345365 PHS_AssignmentRequestForm_4_0-4.0.pdf
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