This NCCIH grant is for investigator-initiated clinical trials of complementary and integrative health interventions. The focus is on fully remotely delivered and conducted trials to assess efficacy or effectiveness, with no in-person contact between staff and participants, and may utilize mHealth tools. Applicants must justify the remote approach and provide preliminary data on its feasibility, safety, and the intervention’s promise of clinical benefit. This opportunity supports fully powered clinical trials within NCCIH-designated high-priority research areas, fostering innovation in digital health for complementary and integrative medicine.
Opportunity ID: 357303
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-268 |
| Funding Opportunity Title: | Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (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: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Nov 21, 2024 |
| Last Updated Date: | Mar 31, 2025 |
| Original Closing Date for Applications: | Nov 17, 2026 |
| Current Closing Date for Applications: | Nov 17, 2026 |
| Archive Date: | Dec 23, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education City or township governments Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses County governments Public housing authorities/Indian housing authorities 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated fully remotely delivered and conducted clinical trials to assess the efficacy or effectiveness of complementary and integrative health interventions in NCCIH- designated areas of high research priority. Applications submitted under this NOFO are expected to propose a remotely delivered and conducted fully powered clinical trial with no in-person contact between research staff and study participants and may utilize mHealth tools or technologies. Applicants must provide justification for the remotely delivered approach and provide preliminary data on the feasibility and safety of the approach, along with evidence that the intervention has promise of clinical benefit. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-268.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 |
|---|---|---|
| Description updated | Mar 31, 2025 | |
| Nov 21, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-268 |
| Funding Opportunity Title: | Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (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: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Nov 21, 2024 |
| Last Updated Date: | Mar 31, 2025 |
| Original Closing Date for Applications: | Nov 17, 2026 |
| Current Closing Date for Applications: | Nov 17, 2026 |
| Archive Date: | Dec 23, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education City or township governments Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses County governments Public housing authorities/Indian housing authorities 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated fully remotely delivered and conducted clinical trials to assess the efficacy or effectiveness of complementary and integrative health interventions in NCCIH- designated areas of high research priority. Applications submitted under this NOFO are expected to propose a remotely delivered and conducted fully powered clinical trial with no in-person contact between research staff and study participants and may utilize mHealth tools or technologies. Applicants must provide justification for the remotely delivered approach and provide preliminary data on the feasibility and safety of the approach, along with evidence that the intervention has promise of clinical benefit. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-268.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-25-268 |
| Funding Opportunity Title: | Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (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: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 21, 2024 |
| Last Updated Date: | Nov 21, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Nov 17, 2026 |
| Archive Date: | Dec 23, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments For profit organizations other than small businesses Small businesses Independent school districts State governments Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities City or township governments Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public and State controlled institutions of higher education 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated fully remotely delivered and conducted clinical trials to assess the efficacy or effectiveness of complementary and integrative health interventions in NCCIH- designated areas of high research priority. Applications submitted under this NOFO are expected to propose a remotely delivered and conducted fully powered clinical trial with no in-person contact between research staff and study participants and may utilize mHealth tools or technologies. Applicants must provide justification for the remotely delivered approach and provide preliminary data on the feasibility and safety of the approach, along with evidence that the intervention has promise of clinical benefit. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-268.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
Folder 357303 Full Announcement-PAR-25-268 -> PAR-25-268-Full-Announcement.pdf
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-I | Use for due dates on or after January 25, 2025 | PKG00288881 | Jan 20, 2025 | Nov 17, 2026 | View |
Package 1
Mandatory forms
357303 RR_SF424_5_0-5.0.pdf
357303 PHS398_CoverPageSupplement_5_0-5.0.pdf
357303 RR_OtherProjectInfo_1_4-1.4.pdf
357303 PerformanceSite_4_0-4.0.pdf
357303 RR_KeyPersonExpanded_4_0-4.0.pdf
357303 PHS398_ResearchPlan_5_0-5.0.pdf
357303 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357303 RR_Budget_3_0-3.0.pdf
357303 RR_SubawardBudget30_3_0-3.0.pdf
357303 PHS398_ModularBudget_1_2-1.2.pdf
357303 PHS_AssignmentRequestForm_4_0-4.0.pdf
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