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.Apply for PAR 24 086
- 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.
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FAQs: NIH NCCIH PAR-24-086 (R01) Fully Remote Clinical Trials
What is PAR-24-086 funding?
PAR-24-086 is a National Institutes of Health (NIH) funding opportunity from the National Center for Complementary and Integrative Health (NCCIH) that supports investigator-initiated R01 clinical trials conducted fully remotely. The goal 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.
What type of award mechanism is used?
This opportunity uses the NIH R01 grant mechanism (activity code R01).
What kinds of studies are supported?
The opportunity supports fully powered clinical trials designed to rigorously test complementary and integrative health interventions. The emphasis is on definitive trials (not exploratory pilots) with credible methods, reliable outcome capture, and appropriate remote safety monitoring.
Does the clinical trial have to be fully remote?
Yes. A defining expectation is that all key study activities occur without any in-person contact between research staff and participants. End-to-end remote execution is expected across recruitment, screening, consent, randomization, intervention delivery, follow-up, and outcome assessment.
Are hybrid or partially remote trials allowed?
Based on the information provided, the remote approach is not optional or secondary. Applicants are expected to propose trials that are end-to-end remote rather than hybrid models that include in-person contact.
What does "end-to-end remote" mean for study operations?
End-to-end remote means the trial is designed so participants can enroll and participate entirely at a distance, including recruitment, screening, consent, randomization, receiving the intervention, completing follow-up, and having outcomes assessed, all without in-person encounters with the research team.
What is the scientific purpose of requiring a fully remote design?
The application must justify why remote delivery is appropriate for the intervention and population and explain how remote methods strengthen the science, feasibility, scalability, or public health relevance compared with an in-person approach.
What types of interventions are in scope?
Interventions should be complementary and integrative health interventions that align with NCCIH-designated areas of high research priority.
What is the main research question these trials should answer?
The core purpose is to test the efficacy or real-world effectiveness of eligible complementary and integrative health interventions.
Can the trial use mobile health (mHealth) tools or other technologies?
Yes. Projects may rely on mHealth tools and other technologies to deliver interventions, collect outcomes, monitor adherence, and manage participant safety.
What remote-trial challenges should applicants address?
The opportunity highlights that remote trials can raise unique methodological and operational issues. Applications should address topics such as verifying participant identity, ensuring protocol fidelity, handling technology barriers, maintaining engagement, and monitoring and responding to adverse events remotely.
What level of readiness is expected from applicants?
The opportunity places strong weight on readiness and credibility for a full-scale clinical trial. Reviewers are expected to look for evidence that the team can recruit and retain participants remotely, deliver the intervention with adequate fidelity, capture primary outcomes reliably outside a clinic setting, and manage risks with remote safety monitoring.
Is preliminary data required?
Yes. Applicants are expected to provide preliminary data showing that the remote procedures are feasible and safe, and they must also provide evidence that the intervention has promise of clinical benefit.
How much prior evidence is expected for the intervention?
The intervention should not be speculative. It should have enough prior evidence (such as pilot data, earlier phase trials, or a strong mechanistic and clinical rationale) to justify conducting a fully powered R01 clinical trial.
What are reviewers likely to look for regarding remote feasibility?
Based on the description, reviewers will likely look for proof that remote recruitment and retention are achievable, remote delivery can be done with adequate fidelity, outcomes can be measured reliably outside a clinic, and participant risks can be managed appropriately through remote safety monitoring plans.
Should applicants contact NCCIH before submitting?
Yes. Applicants are encouraged to communicate with the relevant NCCIH scientific/research contact prior to submission to confirm fit with NCCIH priorities, discuss trial design expectations, and clarify alignment with NCCIH mission and outcomes.
Why is pre-submission communication particularly important for this opportunity?
Remote and technology-enabled trials can involve additional operational, regulatory, and data integrity considerations that may affect peer review. Early communication can help applicants clarify expectations and fit.
What is the Plan for Enhancing Diverse Perspectives (PEDP)?
The PEDP is a strict administrative requirement in this opportunity. It is evaluated during scientific and technical peer review and must be included in the application.
What happens if an application does not include a PEDP?
Applications that do not include a PEDP will be treated as incomplete and withdrawn without review.
What kinds of strategies can be included in a PEDP for a remote trial?
Examples mentioned include strategies to broaden and integrate diverse perspectives across the project, such as diversity within the research team, community or participant engagement approaches, and inclusion strategies that address barriers to participation in remote trials (device access, broadband limitations, language needs, disability accommodations, and digital literacy). Approaches to ensure relevance to populations experiencing health disparities can also be included.
Who is eligible to apply?
Eligibility is broad and includes many common NIH applicant types, including various U.S. government entities, institutions of higher education (public and private), federally recognized Native American tribal governments, tribal organizations (including those not federally recognized), public housing authorities/Indian housing authorities, nonprofits (with or without 501(c)(3) status, other than higher education institutions), for-profit organizations (other than small businesses), and small businesses.
Are minority-serving or community-based institutions included as eligible applicants?
Yes. The opportunity specifically calls out eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations, among others.
Are U.S. territories eligible to apply?
Yes. U.S. territories or possessions are included among eligible applicants.
Can a non-U.S. (foreign) organization apply as the applicant?
No. Non-U.S. (foreign) organizations are not eligible to apply.
Can a U.S. organization include a non-U.S. component?
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 when justified and compliant with NIH policy.
What is the opportunity category?
The opportunity category is discretionary.
What is the CFDA number for this opportunity?
The health-related CFDA number listed is 93.213.
What is the closing date shown in the listing?
The original closing date shown is November 17, 2026.
Is there an award ceiling or expected number of awards listed?
No. The listing does not specify an award ceiling or an expected number of awards.
How should applicants think about budget expectations if no ceiling is listed?
Because the listing does not specify a ceiling or expected award count, applicants are generally expected to rely on the full NOFO text and NCCIH/NIH guidance for budget expectations and project period limits typical for R01 clinical trials.
What overall type of team or project is this opportunity aimed at?
This opportunity is aimed at teams that are ready to run a definitive, well-controlled clinical trial of a complementary or integrative intervention using fully remote and/or mHealth-enabled methods, with careful attention to feasibility, safety, data quality, and inclusion of diverse perspectives.
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