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Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth

National Institutes of Health

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:	$

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

AI Based Application Success Predictor

1. Significance (Importance of the Research Question) (Highest Predictor ⭐⭐⭐⭐⭐)

This is one of NIH's core review criteria.

Competitive proposals should:

Address an important biomedical or public health problem.
Fill a significant knowledge gap.
Advance scientific understanding.
Improve prevention, diagnosis, treatment, or health outcomes.

Reviewers ask whether successful completion of the project will have a meaningful impact on the field.

2. Strong alignment with the Funding Opportunity Announcement (FOA) and Institute priorities (Highest Predictor ⭐⭐⭐⭐⭐)

Competitive applications closely match:

The objectives of the specific FOA.
The mission of the relevant NIH Institute or Center (e.g., NCI, NHLBI, NIDDK, NIAID, NHGRI).
The scientific priorities described in the funding announcement.

Even scientifically strong proposals are less competitive if they do not fit the FOA or Institute mission.

3. Innovation (Highest Predictor ⭐⭐⭐⭐⭐)

Innovation is a formal NIH review criterion.

Competitive proposals often include:

Novel hypotheses.
New technologies.
Innovative methodologies.
Creative experimental approaches.
New therapeutic or diagnostic strategies.
Artificial intelligence or advanced computational methods (when appropriate).

Projects should demonstrate how they advance beyond current knowledge rather than simply extending existing work.

4. Rigorous Approach and Methodology (Highest Predictor ⭐⭐⭐⭐⭐)

The Approach section is often the most heavily scrutinized part of an NIH application.

Competitive proposals include:

Well-defined hypotheses.
Strong preliminary rationale (especially for R01s).
Robust experimental design.
Appropriate statistical analyses.
Risk mitigation strategies.
Alternative approaches.
Realistic timelines and milestones.

A weak approach can prevent funding even for highly innovative ideas.

5. Investigator(s) and Team Expertise (Very High Predictor ⭐⭐⭐⭐⭐)

Reviewers evaluate whether the investigators have the expertise to complete the proposed work.

Competitive teams demonstrate:

Strong publication record.
Relevant scientific expertise.
Leadership experience.
Complementary multidisciplinary skills.
Successful collaboration.

For early-stage investigators, reviewers place greater emphasis on potential and mentorship.

6. Strong Research Environment (Very High Predictor ⭐⭐⭐⭐⭐)

The institutional environment should provide:

Appropriate laboratories and equipment.
Core facilities.
Clinical infrastructure (when applicable).
Biostatistical support.
Institutional commitment.
Collaborative opportunities.

A strong research environment increases confidence that the project can be successfully completed.

7. Scientific Rigor, Reproducibility, and Transparency (Very High Predictor ⭐⭐⭐⭐⭐)

NIH places strong emphasis on:

Scientific rigor.
Reproducibility.
Authentication of key biological resources.
Consideration of sex as a biological variable (when applicable).
Transparent reporting.
Data management and sharing.

Applications should clearly describe how rigor and reproducibility will be ensured throughout the study.

8. Strong Preliminary Data (especially for R01s) (High Predictor ⭐⭐⭐⭐☆)

For many NIH mechanisms—particularly R01—competitive applications often include preliminary data demonstrating:

Feasibility.
Technical capability.
Early proof of concept.
Supporting evidence for the central hypothesis.

Mechanisms such as R21 may place less emphasis on preliminary data, depending on the FOA.

9. Potential for Translation and Public Health Impact (High Predictor ⭐⭐⭐⭐☆)

Competitive proposals often describe how the research could lead to:

New diagnostics.
New therapeutics.
Clinical trials.
Precision medicine.
Public health interventions.
Improved healthcare delivery.

Even basic science applications benefit from articulating their long-term translational relevance.

10. Appropriate Budget, Data Sharing, and Compliance (High Predictor ⭐⭐⭐⭐☆)

Strong applications include:

Well-justified budgets.
Realistic resource requests.
Data Management and Sharing Plans (required for applicable applications).
Compliance with NIH policies on human subjects, vertebrate animals, inclusion, and research ethics.

Administrative completeness and compliance support a smoother review process.

Specialties

Others

Public Health

Eligibility Requirements

Eligible Applicants:

Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Small businesses
Private institutions of higher education
State governments
Native American tribal governments (Federally recognized)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Independent school districts
City or township governments
Special district governments
Public housing authorities/Indian housing authorities
Public and State controlled institutions of higher education
For profit organizations other than small businesses
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; 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.

Eligible Countries:

United States

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Sponsor Type: Government/Federal

Address: 9000 Rockville Pike, Bethesda, MD 20892

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