Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required) | PAR 24 086

Opportunity Information: Apply for PAR 24 086

This funding opportunity (PAR-24-086) from the National Institutes of Health, through the National Center for Complementary and Integrative Health (NCCIH), supports investigator-initiated R01 clinical trials that are conducted fully remotely. The core purpose is to test the efficacy or real-world effectiveness of complementary and integrative health interventions that align with NCCIH-designated areas of high research priority. The emphasis is on rigorous, fully powered trials where all key study activities are delivered and carried out without any in-person contact between research staff and participants. Projects may rely on mobile health (mHealth) tools and other technologies to deliver the intervention, collect outcomes, monitor adherence, and manage participant safety.

A defining feature of the NOFO is that the remote approach is not optional or secondary; applicants are expected to design trials that are end-to-end remote, meaning recruitment, screening, consent, randomization, intervention delivery, follow-up, and outcome assessment occur at a distance. Because remote trials can introduce unique methodological issues (for example, verifying participant identity, ensuring protocol fidelity, handling technology barriers, maintaining engagement, and monitoring adverse events), the application must clearly justify why remote delivery is appropriate for the intervention and population and why it strengthens the science, feasibility, scalability, or public health relevance compared with an in-person approach.

The NOFO also places strong weight on readiness and credibility for a full-scale clinical trial. Applicants are expected to provide preliminary data showing the remote procedures are feasible and safe, and they must also provide evidence that the intervention has promise of clinical benefit. In practice, that means reviewers will be looking for proof that the team can recruit and retain participants remotely, deliver the intervention with adequate fidelity, capture primary outcomes reliably outside of a clinic setting, and manage risks using remote safety monitoring plans. The intervention itself should not be speculative; it should have enough prior evidence (pilot data, earlier phase trials, or strong mechanistic and clinical rationale) to justify a fully powered R01 trial.

Applicants are encouraged to communicate with the relevant NCCIH scientific/research contact before submitting, particularly to confirm fit with NCCIH priorities, discuss trial design expectations, and clarify how the proposed intervention and outcomes align with the Center's mission. This kind of pre-submission contact is often valuable in remote and technology-enabled trials because of the extra operational, regulatory, and data integrity considerations that can affect peer review.

A strict administrative requirement in this NOFO is the Plan for Enhancing Diverse Perspectives (PEDP). The PEDP will be evaluated during scientific and technical peer review, and applications that do not include a PEDP will be treated as incomplete and withdrawn without review. Practically, this means applicants need to describe concrete strategies to broaden and integrate diverse perspectives across the project, which can include (depending on the project) diversity in the research team, community or participant engagement approaches, inclusion strategies that address barriers to participation in remote trials (such as device access, broadband limitations, language, disability accommodations, and digital literacy), and methods to ensure the study is relevant to populations that experience health disparities.

Eligibility is broad and includes many common NIH applicant types: state, county, city, township, and 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses. The NOFO also calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, non-U.S. (foreign) organizations are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may include certain international elements when justified and compliant with NIH policy.

Key administrative details from the listing include that the mechanism is a grant under the R01 activity, the opportunity category is discretionary, the health-related CFDA number is 93.213, and the original closing date shown is November 17, 2026. The listing does not specify an award ceiling or expected number of awards, which generally means applicants should rely on the NOFO text and NCCIH/NIH guidance for budget expectations and project period limits typical for R01 trials. Overall, the opportunity is aimed at teams ready to run a definitive, well-controlled clinical trial of a complementary or integrative intervention using remote and/or mHealth-enabled methods, with careful attention to feasibility, safety, data quality, and inclusion of diverse perspectives.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213.
• This funding opportunity was created on 2023-12-20.
• Applicants must submit their applications by 2026-11-17. (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.

Apply for PAR 24 086

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