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.Apply for PAR 20 154
- 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.
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FAQs: NIH NCCIH PAR-20-154 (R01) Fully Remote Complementary and Integrative Health Clinical Trials
What is PAR-20-154?
PAR-20-154 is a funding opportunity from the NIH National Center for Complementary and Integrative Health (NCCIH) that supports investigator-initiated R01 clinical trials of complementary and integrative health interventions delivered entirely at a distance (fully remote).
What type of grant mechanism is this?
This opportunity uses the NIH R01 activity code. It is designated as “clinical trial required,” meaning the application must include the full set of NIH clinical trial elements and meet NIH expectations for clinical trial rigor.
What does “fully remote” mean under this opportunity?
“Fully remote” means there is no in-person contact at any point between research staff and participants. The trial must be end-to-end remote, including consent, intervention delivery, and assessments, as well as follow-up and safety monitoring.
Are any in-person visits allowed for screening, consent, intervention delivery, or outcome assessments?
No. A defining requirement is that the trial is conducted with no in-person contact at any time between participants and study staff. The design needs to be remote for consent, delivery, and all assessments.
What kinds of interventions are appropriate?
The intervention must be a complementary or integrative health approach and should align with NCCIH-designated areas of high research priority. The focus is not simply on remote delivery as the innovation; the intervention/condition pairing should fit NCCIH priorities.
Does proposing remote delivery by itself satisfy the intent of the FOA?
No. The opportunity emphasizes that applicants need to align the intervention and target condition with NCCIH high-priority research areas. Remote delivery alone is not intended to be the primary innovation.
What types of trials does this FOA support: efficacy or effectiveness?
The FOA supports rigorous efficacy or effectiveness clinical trials, conducted entirely remotely.
Are feasibility studies or pilot trials allowed?
No. Applications are expected to be ready for a full clinical trial at the R01 level, not a feasibility study or pilot study.
What preliminary data are applicants expected to have?
Applicants are expected to provide strong preliminary data that justify moving to a full R01 remote clinical trial, including evidence that:
- Remote recruitment and enrollment are workable for the intended population.
- Participants can adhere to the intervention without in-person support.
- Participants can be retained through the end of the study, including successful final outcome data collection.
- The intervention is safe in the proposed remote context.
- There are credible signals the intervention could provide clinical benefit.
What counts as evidence that the “remote workflow” is workable?
The FOA indicates reviewers will look for evidence that the end-to-end remote workflow has already been tested, such as prior remote studies, pilot data, or completed related studies, along with a realistic plan for engagement, adherence tracking, minimizing attrition, and handling missing data.
What remote technologies can be used to run the trial?
Studies may rely on mobile health (mHealth) tools and other remote technologies for recruiting, delivering the intervention, collecting outcomes, monitoring safety, and managing follow-up. Examples listed include smartphone apps, text messaging platforms, wearable sensors, telehealth-based coaching, web-based programs, and other digital tools.
Can the trial use telehealth or digital coaching?
Yes. Telehealth-based coaching is specifically mentioned as a possible remote approach, as long as the trial remains fully remote and the intervention remains a complementary or integrative health approach.
Does the FOA reduce expectations for clinical trial quality because the study is remote?
No. The opportunity emphasizes that remote conduct does not lower expectations for clinical trial rigor. Applications still need a well-justified design, clear outcomes, appropriate control/comparator as needed, a strong statistical plan, and realistic remote procedures for safety monitoring and adverse event reporting.
What does NIH expect in the clinical trial design and analysis plan?
Because this is an R01 clinical trial opportunity, applicants are expected to present protocol-level detail on design and analysis, including clear outcome measures, an appropriate control or comparator as needed, and a strong statistical plan that addresses remote-trial challenges such as missing data.
What human subjects and safety elements are expected?
The application is expected to include clear human subjects protections and data and safety oversight appropriate to risk, along with realistic procedures for participant safety monitoring and adverse event reporting under remote conditions.
What are common remote-trial challenges reviewers may focus on?
The FOA highlights common review concerns in fully remote trials, including verifying participant identity, ensuring data integrity, addressing technology access barriers, and managing participant risk without onsite visits.
Is it recommended to contact NCCIH before submitting?
Yes. NCCIH strongly encourages prospective applicants to contact the relevant Scientific or Research contact prior to submission to discuss fit with NCCIH priorities and to confirm the proposal meets the “fully remote, no in-person contact” requirement.
Why does NCCIH encourage pre-submission contact?
The FOA notes that NCCIH priorities can be specific, and early discussion can help clarify whether the proposed intervention, population, outcomes, and trial aims match the intent of the opportunity and meet the fully remote requirement. These discussions can also help applicants anticipate common review concerns in remote trials.
Who is eligible to apply?
Eligibility is broad and includes many domestic (U.S.) organizations and governments. Eligible applicants listed include:
- State, county, 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
- Other entities
Are specific institution types called out as eligible?
Yes. The FOA highlights additional eligible applicant types, including 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.
Are foreign (non-U.S.) organizations eligible to apply as the applicant?
No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization for this opportunity.
Are non-domestic components of U.S. organizations eligible to apply?
No. Non-domestic components of U.S. organizations are not eligible to apply under this FOA.
Are any foreign elements allowed at all?
Yes. The FOA states that foreign components, as defined by NIH in the NIH Grants Policy Statement, are allowable. This means a U.S. applicant organization may include certain foreign elements under NIH rules even though a foreign institution cannot be the applicant.
What is the assistance listing (CFDA) number for this opportunity?
The CFDA/assistance listing number provided is 93.213.
When was this funding opportunity created?
The funding announcement was created on March 30, 2020.
What is the listed original closing date in the provided information?
The listed original closing date in the provided source is September 7, 2023.
Is there a stated award ceiling or a stated number of expected awards?
No. The provided listing does not specify an award ceiling or an expected number of awards. It notes that applicants typically should rely on the FOA text and NIH guidance for budget reasonableness and institute funding availability rather than expecting a stated maximum.
What is NCCIH looking for overall in applications to this FOA?
The FOA is aimed at teams that already have enough early evidence to credibly run a full-scale remote clinical trial of a complementary or integrative intervention. Applicants are expected to show they can recruit, treat, and follow participants entirely remotely without losing scientific rigor, while targeting questions aligned with NCCIH high-priority research areas and producing results that can inform real-world clinical or public health decisions.
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