Opportunity Information: Apply for PAR 21 241
The NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions funding opportunity (PAR-21-241) is a National Institutes of Health (NIH) R01 grant designed to support investigator-initiated, multi-site feasibility clinical trials focused on complementary and integrative health approaches that use physical and/or psychological therapeutic inputs, commonly referred to as mind and body interventions. The central purpose is not to prove that an intervention works in the definitive sense, but to determine whether a larger, fully powered multi-site trial is practical and can be executed rigorously across multiple locations. NCCIH is looking for projects aligned with its designated areas of high research priority, and it expects applicants to build a strong justification for why a multi-site feasibility study is needed at this point in the intervention development pipeline.
A key expectation under this FOA is that proposed studies will directly test the operational readiness of a future large-scale trial across more than one site. That includes showing that the intervention can be delivered with fidelity across sites, meaning the intervention is implemented consistently and according to protocol despite differences in personnel, setting, and participant populations. Applicants are also expected to demonstrate feasibility of recruitment, accrual, and randomization across sites, along with participant adherence to the intervention and retention through follow-up. In addition, the FOA emphasizes the importance of demonstrating the feasibility of data collection across sites, which often includes testing common data elements, harmonized procedures, and the reliability of outcomes assessment across different teams and locations. The overall deliverable is a clear, evidence-based path toward a later, fully powered multi-site trial by identifying and addressing logistical, methodological, and implementation barriers early.
This opportunity is explicitly not intended to support randomized clinical trials aimed at determining efficacy or effectiveness. In other words, even if randomization is used as part of feasibility testing, the study should not be framed or powered as a definitive test of clinical benefit. Instead, the data collected should fill specific gaps that would otherwise prevent a competitive, well-designed future trial. Examples of the kinds of gaps this FOA is meant to address include uncertainties about recruitment rates in different settings, the acceptability of randomization, adherence challenges, site-to-site variability in intervention delivery, missing data patterns, outcome measurement performance, and the practicality of standardizing training and quality assurance across sites. The expectation is that the feasibility outcomes will directly inform the design choices, resource needs, and risk mitigation strategies for a later trial with stronger public health impact potential.
NCCIH also signals that applications should be grounded in sufficient preliminary evidence to justify moving from single-site exploration to multi-site feasibility. That preliminary justification can come from earlier single-site feasibility or acceptability studies or from a strong published literature base indicating that the intervention is promising enough to warrant the added complexity and cost of a multi-site effort. In practical terms, applicants should be prepared to explain why single-site data are no longer enough, what uncertainties remain that only a multi-site feasibility study can resolve, and how the proposed work will reduce the likelihood of failure in a subsequent large trial.
The FOA encourages prospective applicants to communicate with the relevant NCCIH Scientific/Research contact before submitting. This is a practical cue that NCCIH expects alignment with its priority areas and prefers that applicants clarify fit, scope, and feasibility-trial expectations early. These pre-submission conversations can help ensure that the application is framed around feasibility milestones rather than definitive clinical outcomes, and that the proposed intervention and study design match NCCIH programmatic interests.
In terms of eligibility, the program is broadly open to many U.S.-based organization types typically eligible for NIH grants, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; tribal governments (federally recognized); tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible agencies of the federal government, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. However, foreign components, as defined under NIH policy, are allowed, which generally means discrete elements of the project may be conducted outside the U.S. when they provide special expertise, resources, populations, or conditions not readily available domestically, consistent with NIH rules.
Administratively, this is a discretionary grant mechanism under the NIH, categorized under health (CFDA 93.213). The FOA was created on June 14, 2021, and the source information provided lists an original closing date of December 21, 2023. The listed award ceiling is $350,000, indicating an upper bound reflected in the posting (applicants would still need to follow the FOA-specific budgeting instructions and NIH cost principles). The instrument type is a grant and the activity code is R01, which generally supports discrete, specified, and circumscribed research projects, but here it is specifically tailored to multi-site feasibility clinical trials with required clinical trial features.
Overall, the opportunity is aimed at teams ready to take a promising mind and body intervention from earlier groundwork into a more realistic, real-world test of whether a multi-site trial can be done well. The strongest applications will keep the focus on feasibility metrics, cross-site standardization, quality control, recruitment and retention performance, adherence and fidelity monitoring, and data collection infrastructure, all tied to a clear plan for how the results will de-risk and strengthen a later, fully powered trial that could meaningfully affect public health.Apply for PAR 21 241
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (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 2021-06-14.
- Applicants must submit their applications by 2023-12-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $350,000.00 in funding.
- 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: NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (PAR-21-241)
What is this funding opportunity?
This is an NIH R01 funding opportunity from the National Center for Complementary and Integrative Health (NCCIH) to support investigator-initiated, multi-site feasibility clinical trials of mind and body interventions (PAR-21-241).
What is the main goal of the FOA?
The main goal is to determine whether a larger, fully powered multi-site clinical trial is practical and can be carried out rigorously across multiple locations. The emphasis is on feasibility and operational readiness, not on proving definitive clinical benefit.
What types of interventions are in scope?
The FOA focuses on complementary and integrative health approaches that use physical and/or psychological therapeutic inputs, commonly referred to as mind and body interventions.
Is this FOA meant to fund a definitive efficacy or effectiveness trial?
No. This opportunity is explicitly not intended to support randomized clinical trials aimed at determining efficacy or effectiveness. Even if randomization is included, the study should not be framed or powered as a definitive test of clinical outcomes.
What does NCCIH mean by a "multi-site feasibility clinical trial" in this context?
It refers to a clinical trial conducted at more than one site where the primary purpose is to test whether the procedures, infrastructure, and cross-site operations can work reliably enough to justify a later, fully powered multi-site trial.
What kinds of feasibility questions should a project answer?
Projects should address uncertainties that could prevent a future large trial from succeeding, such as recruitment and accrual performance across sites, acceptability of randomization, participant adherence, retention through follow-up, site-to-site variability, missing data patterns, outcome measurement performance, and the practicality of standardizing training and quality assurance across sites.
What are the expected deliverables from an awarded project?
The expected deliverable is a clear, evidence-based path toward a later, fully powered multi-site trial. This includes identifying logistical, methodological, and implementation barriers early and generating feasibility results that directly inform design choices, resource needs, and risk mitigation strategies for the future trial.
Why does NCCIH require a strong justification for doing a multi-site feasibility study now?
NCCIH expects applicants to explain why moving from single-site work to multi-site feasibility is appropriate at this stage, what uncertainties remain that only a multi-site feasibility study can resolve, and how the proposed work will reduce the risk of failure in a subsequent large trial.
What preliminary evidence is expected before applying?
Applications are expected to be grounded in sufficient preliminary evidence to justify a multi-site feasibility effort. This could come from earlier single-site feasibility or acceptability studies or from a strong published literature base indicating the intervention is promising enough to warrant the complexity and cost of a multi-site study.
What does "intervention fidelity across sites" mean, and why is it important?
Intervention fidelity means the intervention is delivered consistently and according to protocol across different sites, even when personnel, settings, or participant populations differ. Testing fidelity is important because inconsistent delivery across sites can undermine the integrity of a future large-scale trial.
What operational elements across sites are applicants expected to test?
Applicants are expected to test multi-site readiness elements such as recruitment, accrual, randomization processes, participant adherence, retention, standardized intervention delivery, cross-site training and quality assurance, and the feasibility and consistency of data collection across locations.
What does the FOA emphasize about data collection in a multi-site setting?
The FOA emphasizes demonstrating feasibility of data collection across sites, which can include testing common data elements, harmonized procedures, and the reliability of outcomes assessment across different teams and locations.
Can randomization be included in the study design?
Yes, randomization can be used as part of feasibility testing (for example, to test acceptability and operational performance), but the study should not be positioned or powered as a definitive test of clinical benefit.
What are examples of "gaps" this FOA is intended to address?
Examples include uncertainty about recruitment rates in different settings, whether participants accept randomization, adherence challenges, site-to-site variability in intervention delivery, missing data patterns, how well outcome measures perform, and whether training and quality assurance can be standardized across sites.
How should applicants frame outcomes and success criteria?
Applicants should frame outcomes around feasibility milestones and metrics (such as recruitment, adherence, retention, fidelity, and data completeness), showing how the results will inform and strengthen the design of a later, fully powered multi-site trial.
Does NCCIH expect alignment with specific research priorities?
Yes. NCCIH is looking for projects aligned with its designated areas of high research priority, and applicants are expected to justify how the proposed work fits NCCIH programmatic interests.
Is it recommended to contact NCCIH before submitting an application?
Yes. The FOA encourages prospective applicants to communicate with the relevant NCCIH Scientific/Research contact before submitting to clarify fit, scope, and feasibility-trial expectations.
What is the grant mechanism and activity code?
This is an NIH grant using the R01 activity code, which supports discrete, specified, and circumscribed research projects. In this FOA, the R01 is tailored specifically to multi-site feasibility clinical trials with required clinical trial features.
What is the CFDA number and general category?
The opportunity is categorized under health and is listed under CFDA 93.213.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organization types typically eligible for NIH grants. Examples include state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; tribal governments (federally recognized); tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.
Are specific institution types explicitly included as eligible?
Yes. The FOA lists additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, eligible agencies of the federal government, and U.S. territories or possessions.
Are non-U.S. organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible.
Are foreign components allowed at all?
Yes. Foreign components, as defined under NIH policy, are allowed. This generally means discrete elements of the project may be conducted outside the U.S. when they provide special expertise, resources, populations, or conditions not readily available domestically, consistent with NIH rules.
What is the listed award ceiling?
The source information provided lists an award ceiling of $350,000. Applicants would still need to follow FOA-specific budgeting instructions and NIH cost principles.
When was this FOA created and what closing date is listed?
The FOA was created on June 14, 2021, and the provided source information lists an original closing date of December 21, 2023.
What type of funding instrument is this?
This opportunity uses a grant instrument type and is described as a discretionary grant mechanism under NIH.
What should a strong application emphasize to match this FOA?
A strong application should keep the focus on feasibility metrics and cross-site execution, including standardization, quality control, recruitment and retention performance, adherence and fidelity monitoring, and data collection infrastructure. It should also explain how the feasibility results will directly de-risk and strengthen a later fully powered multi-site trial with public health impact potential.
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