Laboratories to Optimize Digital Health (R01 Clinical Trial Required)
Can you apply?
This grant is for research institutions and academic medical centers developing and testing digital health technologies in clinical settings. Eligible applicants include nonprofit research institutions, colleges and universities, hospitals, and some for-profit organizations with established research capacity. The program focuses on early-to-mid-stage research involving digital health interventions that require clinical trials. Applicants must have institutional infrastructure to conduct human subjects research and IRB approval capabilities.
Geographic scope includes all U.S. states and territories. The grant supports development and validation of digital health tools, apps, and platforms through rigorous clinical testing. Priority is given to projects addressing health disparities and improving access to care through technology.
This grant is for research institutions and academic medical centers developing and testing digital health technologies in clinical settings. Eligible applicants include nonprofit research institutions, colleges and universities, hospitals, and some for-profit organizations with established research capacity. The program focuses on early-to-mid-stage research involving digital health interventions that require clinical trials. Applicants must have institutional infrastructure to conduct human subjects research and IRB approval capabilities.
Geographic scope includes all U.S. states and territories. The grant supports development and validation of digital health tools, apps, and platforms through rigorous clinical testing. Priority is given to projects addressing health disparities and improving access to care through technology.
Program description
NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions. This NOFO is intended to support the development of digital health test beds that leverage well-established digital mental health platforms,to rapidly refine and optimize existing evidence-based digital health interventions and conduct clinical trials testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention’s effectiveness.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for research institutions and academic medical centers developing and testing digital health technologies in clinical settings. Eligible applicants include nonprofit research institutions, colleges and universities, hospitals, and some for-profit organizations with established research capacity. The program focuses on early-to-mid-stage research involving digital health interventions that require clinical trials. Applicants must have institutional infrastructure to conduct human subjects research and IRB approval capabilities.
Geographic scope includes all U.S. states and territories. The grant supports development and validation of digital health tools, apps, and platforms through rigorous clinical testing. Priority is given to projects addressing health disparities and improving access to care through technology.
How to apply
Application links
Required documents
- SF-424 (R&R) form
- Project Narrative (Research Strategy)
- Detailed Budget and Budget Justification
- Biosketch (NIH format) for all key personnel
- Institutional Review Board (IRB) approval letter or plan
- Letters of support from collaborating institutions
- Preliminary data and feasibility documentation
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$75,056,208
-
$74,756,329
-
$72,845,834
-
$64,705,159
-
$63,991,707
-
$54,214,022
-
$38,895,082
-
$38,475,557
-
$34,635,977
-
$34,475,710
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.3M
- NY 6 awards $184.2M
- WA 4 awards $174.9M
- CT 3 awards $138.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who can apply for this grant?
Research institutions, universities, hospitals, and some for-profit entities with research capacity. Applicants must have IRB approval capability and institutional infrastructure for clinical trials.
What is the typical application deadline?
Fixed deadlines typically fall in January and recurring cycles. Check NIH Grants.gov listing for specific upcoming dates.
What types of digital health projects are funded?
Early-to-mid-stage development and clinical validation of digital health technologies, apps, and platforms. Projects must include human subjects research with clinical trial components.
How competitive is this program?
NIH R01 grants are highly competitive. Success rates typically range 15-25% depending on the specific funding opportunity.
What is the typical funding range?
NIH R01 awards typically support 3-5 year projects. Budget amounts vary but commonly range from $250,000 to $500,000+ per year depending on scope.
💡 Tips for applicants
- Build your research team with digital health expertise and clinical domain specialists early. Strong preliminary data strengthens competitiveness.
- Address health equity explicitly in your proposal. Show how your digital health tool reduces disparities.
- Budget conservatively for human subjects research, IRB costs, and rigorous trial design. Underbudgeting is a common red flag.
- Ensure your preliminary data demonstrates feasibility and user engagement with your digital tool.
- Align your project timeline with realistic clinical recruitment and deployment milestones. Overly ambitious timelines reduce credibility.
⚠️ Common mistakes
Proposing untested digital tools without adequate preliminary data or pilot study results. Vague dissemination plans that don't demonstrate how technology will reach target users or be sustained long-term. Weak clinical trial design or unrealistic timelines for recruiting and retaining human subjects.
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