Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required) | PAR 25 268

Frequently Asked Questions (FAQs)

What is this NIH funding opportunity?

This opportunity is an NIH Notice of Funding Opportunity (NOFO) from the National Center for Complementary and Integrative Health (NCCIH) inviting investigator-initiated R01 applications for fully powered clinical trials that are delivered and conducted entirely remotely.

What is the funding opportunity number?

The funding opportunity number is PAR-25-268.

What grant mechanism is being used?

The NOFO uses the NIH R01 mechanism (a discretionary grant).

What is the CFDA/Assistance Listing number and program area?

The listing is under health, CFDA (Assistance Listing) 93.213.

When is the application due date listed for this opportunity?

The provided listing shows an application due date of 2026-11-17.

What type of clinical trials is NCCIH looking for?

NCCIH is soliciting fully powered clinical trials evaluating the efficacy or effectiveness of complementary and integrative health interventions in NCCIH-designated areas of high research priority, using designs that do not require any in-person contact between the research team and participants.

What does "fully remote" mean for this NOFO?

Fully remote means the trial must be executed end-to-end without face-to-face visits or in-person contact between the research team and participants. All core trial functions (such as intervention delivery, monitoring, data capture, communication, and follow-up) must be feasible without onsite visits.

Are hybrid trials (some in-person and some remote) allowed?

Based on the information provided, the intent is for trials to be delivered and conducted entirely remotely and to avoid any in-person contact. Applications are expected to use study designs that do not require face-to-face visits.

Can mobile health (mHealth) tools or other remote technologies be used?

Yes. Trials may incorporate mHealth tools and other remote technologies for intervention delivery, monitoring, data capture, participant communication, and follow-up, as long as the study remains fully remote end-to-end.

What is the main purpose of the funded studies?

The central aim is to evaluate the efficacy or effectiveness of complementary and integrative health interventions within NCCIH priority areas, using rigorous, adequately powered clinical trial designs that can be conducted entirely remotely.

What kinds of interventions are in scope?

The NOFO focuses on complementary and integrative health interventions in NCCIH-designated areas of high research priority (as referenced in the opportunity description).

Do applicants need to explain why the study must be fully remote?

Yes. A defining feature of this opportunity is the expectation that applicants will justify why a fully remote approach is appropriate and advantageous for the proposed intervention and the target population.

What feasibility evidence is expected for a remote trial?

Applications are expected to include preliminary evidence demonstrating the feasibility and safety of conducting the study remotely, recognizing that remote trials can introduce unique risks and operational challenges.

Is safety planning specifically important for remote delivery?

Yes. The NOFO highlights that remote trials can introduce unique risks and operational challenges, and it expects applicants to provide preliminary evidence and credible plans addressing feasibility and safety in a fully remote setting.

Does the intervention need to show promise before applying?

Yes. Applicants must provide evidence that the intervention itself shows promise of clinical benefit, indicating the proposed study is ready for a rigorous, adequately powered R01 clinical trial rather than an early-stage proof-of-concept effort.

What operational elements should a competitive remote trial plan address?

Based on the description, reviewers will be looking for a credible remote operations plan that addresses recruitment, consent, intervention fidelity, participant onboarding, engagement and adherence support, retention, remote outcome assessment, data security and privacy, data integrity, adverse event monitoring, participant communication, follow-up, and contingency procedures without in-person contact.

Is pre-submission contact with NCCIH encouraged?

Yes. NCCIH explicitly encourages prospective applicants to contact the relevant NCCIH Scientific/Research contact aligned with the proposed scientific area before submitting an application.

Why does NCCIH encourage contacting a Scientific/Research contact before submission?

The pre-submission communication is intended to help ensure the proposed trial fits NCCIH priorities, aligns with the intent of the announcement, and addresses practical issues specific to fully remote delivery and mHealth-enabled research (such as onboarding, adherence support, remote safety monitoring, data integrity, privacy, and contingency procedures).

What is the Plan for Enhancing Diverse Perspectives (PEDP)?

The PEDP is a mandatory plan required by this NOFO. It must provide a concrete approach for incorporating diverse perspectives into the project, consistent with NIH guidance, and should be integrated into the overall trial strategy.

Is the PEDP optional?

No. The PEDP is mandatory and will be evaluated during scientific and technical peer review.

What happens if an application does not include a PEDP?

Applications that do not include a PEDP will be considered incomplete and will be withdrawn without review.

How will the PEDP be evaluated?

The PEDP will be evaluated during scientific and technical peer review, as stated in the opportunity description.

What does NCCIH expect in a strong PEDP for a remote clinical trial?

The description indicates applicants should go beyond general statements and provide a concrete plan for incorporating diverse perspectives in ways that strengthen the science and real-world relevance, such as through the study team, partnerships, recruitment approaches, and/or participant communities, and integrating the plan into the trial strategy rather than treating it as a standalone add-on.

Who is eligible to apply?

Eligibility is broad and includes many domestic organizations and governmental entities, such as state/county/city/township/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; nonprofits (with or without 501(c)(3) status, other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities.

Are minority-serving institutions and community-based organizations included in the eligibility highlights?

Yes. The NOFO highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Are non-U.S. (foreign) organizations eligible to apply as the applicant?

No. Non-domestic (non-U.S.) entities are not eligible to apply.

Are non-domestic components of U.S. organizations eligible?

No. Non-domestic components of U.S. organizations are not eligible to apply.

Are foreign components allowed in some form?

Yes. Foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include certain well-justified foreign activities or collaborations within NIH policy constraints.

Is the award ceiling or number of awards specified in the summary provided?

No. The award ceiling and expected number of awards are not specified in the provided summary information.

How should applicants think about budgets if no award ceiling is stated in the summary?

The provided description suggests applicants should rely on the NOFO and NIH policy for budget structure and reasonableness and pay attention to any institute-specific budgeting guidance or limits described in the full announcement.

What are reviewers likely to look for in these applications?

The description indicates reviewers will look for a strong scientific rationale tied to NCCIH priorities; convincing readiness signals (remote feasibility, remote safety, and intervention promise); and a detailed, credible blueprint for high-quality remote trial operations covering key elements like recruitment, consent, fidelity, engagement/retention, remote outcome assessment, privacy/security, data integrity, and adverse event monitoring, plus a meaningful PEDP integrated into the trial approach.

Is this opportunity limited to randomized clinical trials?

The description references a "remote randomized clinical trial (or other appropriate fully powered design)." This indicates randomized trials are expected in many cases, but other fully powered designs may be appropriate depending on the study.

Does the trial have to be conducted without any face-to-face visits for safety monitoring and adverse events?

Yes. The opportunity emphasizes remote safety monitoring and adverse event monitoring without in-person contact, along with contingency procedures suitable for a fully remote trial.