Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required) | PAR 20 154

Opportunity Information: Apply for PAR 20 154

The NIH National Center for Complementary and Integrative Health (NCCIH) funding opportunity PAR-20-154 supports investigator-initiated R01 clinical trials that test complementary and integrative health interventions delivered entirely at a distance. The central idea is to fund rigorous efficacy or effectiveness trials that are conducted fully remotely, meaning there is no in-person contact at any point between research staff and participants. Studies may rely on mobile health (mHealth) tools and other remote technologies for recruiting participants, delivering the intervention, collecting outcomes, monitoring safety, and managing follow-up. The trials are expected to focus on topics that fall within NCCIH-designated areas of high research priority, so applicants need to align the intervention and target condition with NCCIH priorities rather than proposing remote delivery as the only innovation.

A defining requirement of this FOA is that applications must be ready for a full clinical trial, not a feasibility or pilot study. To justify moving to an R01-level remotely delivered trial, applicants are expected to provide strong preliminary data showing that remote recruitment and enrollment are workable for the intended population, that participants can realistically adhere to the intervention when it is delivered without in-person support, and that participants can be retained through the end of the study with successful completion of final outcome data collection. The preliminary package should also demonstrate that the intervention is safe in the proposed context and that there are credible signals it could provide clinical benefit. In practice, this means reviewers will be looking for evidence that the remote workflow has already been tested (for example, prior remote studies, pilot data, or completed related studies) and that the team has a realistic plan for maintaining engagement, tracking adherence, minimizing attrition, and handling missing data in a remote environment.

Because the FOA is specifically about fully remote clinical trials, the proposed design needs to be end-to-end remote, including consent, intervention delivery, and assessments. Applicants can use mHealth approaches such as smartphone apps, text messaging platforms, wearable sensors, telehealth-based coaching, web-based programs, or other digital tools, as long as the intervention remains a complementary or integrative health approach and the trial methods remain robust. Even though the announcement emphasizes remote conduct, it does not lower expectations for clinical trial quality. Applicants still need to present a well-justified design, clear outcome measures, an appropriate control or comparator as needed, a strong statistical plan, and realistic procedures for participant safety monitoring and adverse event reporting under remote conditions.

NCCIH strongly encourages prospective applicants to contact the relevant Scientific or Research contact at NCCIH before submission. The practical reason is that NCCIH priorities can be specific, and early discussion can help clarify whether the proposed intervention, population, outcomes, and trial aims fit the intent of the FOA, as well as whether the “fully remote, no in-person contact” requirement is met as written. These conversations can also help applicants anticipate common review concerns in remote trials, such as verifying participant identity, ensuring data integrity, addressing technology access barriers, and managing participant risk without onsite visits.

Eligibility is broad and includes many types of domestic organizations and governments. Eligible applicants listed for the opportunity include state, county, and city or township governments; 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities. The FOA also highlights additional eligible applicant types 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, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, the FOA draws a firm boundary around foreign applicants: non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, are allowable, meaning a U.S. applicant organization may include certain foreign elements under NIH rules even though a foreign institution cannot serve as the applicant.

Operationally, this is an NIH discretionary grant mechanism with an R01 activity code and a “clinical trial required” designation, so the application is expected to include all the elements NIH requires for a clinical trial, including clear human subjects protections, a detailed protocol-level approach to design and analysis, data and safety oversight appropriate to risk, and a realistic plan for remote implementation. The funding announcement was created on March 30, 2020, and the listed original closing date in the provided source is September 7, 2023. The CFDA/assistance listing number associated with this opportunity is 93.213. The award ceiling and expected number of awards are not specified in the provided listing, which typically means applicants should rely on the FOA text and NIH guidance for budget reasonableness and institute funding availability rather than expecting a stated maximum.

Taken together, PAR-20-154 is aimed at research teams that already have enough early evidence to credibly run a full-scale remote clinical trial of a complementary or integrative intervention. The program is essentially asking applicants to show that they can recruit, treat, and follow participants entirely remotely without losing scientific rigor, while targeting questions that matter to NCCIH’s high-priority research areas and producing results that can inform real-world clinical or public health decisions.

• 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 2020-03-30.
• Applicants must submit their applications by 2023-09-07. (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 20 154

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: