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Grant Analysis

Purpose & Target

This grant, PAR-25-268, supports investigator-initiated, fully remotely delivered and conducted clinical trials designed to assess the efficacy or effectiveness of complementary and integrative health interventions. The core objective is to build a rigorous evidence base for these approaches, often utilizing mHealth tools or technologies. It targets a broad range of US-based organizations including higher education institutions, various types of nonprofits, for-profit organizations (including small businesses), and federal/local government entities. The grant is SECTOR-SPECIFIC, focusing on healthcare research, particularly complementary and integrative health interventions. The geographic scope for applicant organizations is limited to the United States. While the trials must be fully remote, participants are expected to be geographically distributed across the US, and potentially Canada (trials conducted outside the US or Canada are not responsive). A key filtering criterion is the absolute requirement for a clinical trial that involves no in-person contact between research staff and study participants. This is a recurring grant opportunity, reissued from a previous announcement, with multiple application submission windows available until its expiration date in November 2026.

Financial Structure

This funding opportunity provides a grant (R01 Research Project Grant). While there is no specified total funding amount, nor minimum or maximum award limits per application, the application budget is not limited but must reflect the actual needs of the proposed project. Cost Sharing: This NOFO does not require cost sharing. Eligible Costs: * Costs associated with recruitment and retention of participants. * Translation services and/or interpreters. * Costs for using validated measures in multiple languages. * Costs for publication and dissemination of findings. * Support for Data and Safety Monitoring Board (DSMB) meetings, including materials preparation and travel for key personnel. * Costs for unmasked biostatistician(s) for randomization and DSMB reporting, in addition to masked biostatisticians for study analyses. Co-financing: If parts of the trial's costs are to be provided by sources other than NIH, these contributions must be presented in detail in the budget justification. Payment Schedule & Mechanisms: Not explicitly detailed in this document, but subject to NIH Grants Policy Statement guidelines. Financial Reporting: Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements as specified by NIH policies. A final RPPR and expenditure data are required for closeout. Budget Flexibility: Awards under this NOFO are excluded from automatic carryover of funds; all carryover actions require NCCIH prior approval. Similarly, automatic extensions of the final budget period are not granted; all extensions require NCCIH prior approval. Financial Guarantees: No specific financial guarantees are explicitly required.

Eligibility Requirements

To be eligible for this grant, applicants must meet the following hard, non-negotiable criteria:

Organization Type: Eligible organizations are diverse and include:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (with or without 501(c)(3) IRS Status)
- For-Profit Organizations (including Small Businesses)
- Local Governments (State, County, City/Township, Special District, Federally Recognized Indian/Native American Tribal Governments, and Other Indian/Native American Tribal Governments)
- Federal Governments (Eligible Agencies)
- Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations)
Geographic Location: The applicant organization must be US-based. Foreign organizations and non-U.S. components of U.S. organizations are explicitly ineligible to apply. While foreign components (collaborators, consultants) are allowed, the clinical trials themselves cannot be conducted with participants outside the United States or Canada. The study must recruit a representative sample and not be geographically limited (e.g., to a single city or region).
Project Focus: The application MUST propose an NIH-defined clinical trial focused on assessing the efficacy or effectiveness of complementary and integrative health interventions. The trial must be fully remotely delivered and conducted, meaning there can be no in-person contact between research staff and study participants. Preliminary data demonstrating feasibility and safety of the remote approach, along with evidence of clinical benefit, are essential.
Technical Expertise: The Program Director(s)/Principal Investigator(s) (PD/PI) must be experienced in conducting remotely delivered clinical trials and possess expertise in the trial's content area. A biostatistician is strongly encouraged as part of the team.
Preliminary Data: Extensive preliminary data are required, demonstrating:
- For the intervention: That a similar intervention is well-tolerated, pilot feasibility data (adherence, fidelity, participant retention), successful remote recruitment methods, validity of the primary outcome, justification for remote delivery format/duration, and ability to monitor/address adverse events remotely.
- For the team: Collective experience in conducting remote clinical trials, including successful remote recruitment, randomization, adherence, retention, follow-up, and publication of previous remote trial results.
- For natural products (if applicable): Data showing clinically meaningful change in target engagement, bioavailability, justification of dosing, correlation with clinical outcomes, and pharmacokinetic data (if applicable).
Regulatory Compliance: Applicants must complete and maintain active registrations with the System for Award Management (SAM), obtain a Unique Entity Identifier (UEI), and register with eRA Commons and Grants.gov prior to submission. For interventions involving FDA-regulated products (drugs, devices, natural products), applicants must contact the FDA before applying to determine if an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application is necessary. If required, an open IND/IDE (or exemption letter) must be in place before funding.

Exclusion Criteria/Disqualifying Factors: * Clinical trials with any in-person contact between research staff and participants. * Studies that do not have a primary aim to assess the efficacy or effectiveness of the intervention. * Clinical trials proposing to deliver an intervention to participants outside the United States or Canada. * Studies that are geographically limited (e.g., recruiting from one city or region). * Studies that propose a waitlist control comparator condition. * Trials that include a natural product regulated by the DEA as a controlled substance. * Trials that propose to assess efficacy or effectiveness of interventions for the treatment or prevention of cancer.

Application Process

Application Process & Deadlines

Application Deadline: The latest application due date is October 20, 2026, by 5:00 PM local time of the applicant organization. There are multiple application cycles available prior to this date. Applicants are strongly encouraged to submit early to allow time for corrections.
Letter of Intent: A Letter of Intent is due 30 days prior to the application due date.
Submission Method: Applications must be submitted electronically through the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.

Required Documentation & Materials Applicants must submit a comprehensive package, including: * SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget). * PHS 398 forms (Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information). * A detailed Clinical Trial Experience table (maximum 3 pages), outlining key personnel's experience in trial coordination over the last 5 years. * Research Strategy addressing the importance of research, rigor, feasibility, experimental approach, and milestone plan. * Preliminary Data: Must include detailed preliminary data from previous human studies for the intervention and demonstrating the team's experience with remote clinical trials. For natural products, specific preliminary data is also required. * Resource Sharing Plan. * Data Management and Sharing Plan. * Letters of Support: If applicable, from clinicians, health care systems, subcontractors, consultants, and natural product suppliers (documenting supply availability and compliance). * FDA Correspondence: If proposing an FDA-regulated intervention, documentation of correspondence with the FDA (e.g., pre-IND meeting outcome, IND/IDE exemption letter). Project Implementation & Reporting Obligations

Project Period: The maximum project period is 5 years.
Milestone Plan: A realistic milestone plan is required, including target dates for regulatory approvals, agreements, staff training, enrollment percentages (10%, 25%, 50%, 75%, 100%), data collection, manuscript submission, and ClinicalTrials.gov registration.
Reporting Frequency: Recipients must submit a Research Performance Progress Report (RPPR) annually and financial statements as required. Achievement of milestones must be communicated to the NCCIH Program Officer.
ClinicalTrials.gov: Registration and results reporting are required for applicable clinical trials, with results submission within 12 months of the primary completion date.

Types of Support Offered

Monetary Funding: This is a direct grant award to support the proposed clinical trial activities.
Application Assistance: Support is available from the eRA Service Desk for system issues, Grants.gov Customer Support for registration, and NIH General Grants Information for application instructions. NCCIH Scientific/Research contacts are available for pre-application consultation, especially for requests over $500,000.

Evaluation Criteria

Applications are evaluated for scientific and technical merit through a rigorous peer review system, ultimately influencing an 'Overall Impact' score. Reviewers consider the likelihood of the project to exert a sustained, powerful influence on the research field. Scored Review Criteria: * Importance of Research (Significance and Innovation): Assesses the significance and innovation of the proposed clinical trial, the importance of the research question, how it addresses an evidence gap, its timeliness, cost-benefit analysis, and how it challenges or shifts current research paradigms. Novel collaboration or oversight strategies are a plus. * Rigor and Feasibility (Approach): Evaluates the scientific rigor of the experimental approach, the rationale for the chosen design (e.g., pragmatic, explanatory, cluster-randomized), and its feasibility. This includes a thorough review of supporting preliminary data (from previous human studies or the team's experience) demonstrating the intervention's tolerability, feasibility, adherence, retention, and remote recruitment methods. It also assesses the appropriateness of the study population, methods of randomization, outcome measures, and intervention delivery, as well as plans for data collection, quality standards (GCP, GLP, GMP), and addressing potential challenges. The application must justify the remotely delivered design and include a minimum of 90-percent power for the primary hypothesis. * Expertise and Resources (Investigator(s) and Environment): Assesses the qualifications and experience of the PD/PI and the study team, particularly their experience in conducting remotely delivered clinical trials and expertise in the content area. The application should reflect the roles of all key personnel (e.g., biostatistician). It also evaluates the adequacy of institutional resources and patient populations. Additional Review Criteria (Not Scored, but Considered): * Protections for Human Subjects: Evaluation of proposed measures to protect human participants, especially vulnerable populations (pregnant women, children, prisoners). * Biohazards: Assessment of proposed protections if the research involves hazardous materials or procedures. * Resubmissions/Renewals/Revisions: Evaluation of previous progress or appropriateness of scope changes for these application types. Competitive Advantage Factors and Priorities: * Strong Preliminary Data: Comprehensive and compelling preliminary data demonstrating the feasibility, safety, and effectiveness of the remote delivery method for the intervention, as well as the team's proven track record with remotely conducted trials. * Alignment with NCCIH Priorities: Applications addressing NCCIH's high-priority topic areas (e.g., symptom management, health behaviors, mental health, health disparities, gut microbiome-brain interactions, HIV comorbidities) will be considered of high programmatic priority and are more likely to be funded. * Robust Statistical Design: A detailed Statistical Analysis Plan (SAP) that ensures a minimum of 90% power for the primary outcome, justified power calculations, and appropriate handling of potential issues like missing data or adaptive designs. * Inclusivity: Plans for recruiting a representative sample that includes individuals of all ages, women, and minorities, utilizing validated measures in multiple languages. * Non-duplication: Justification that the proposed work is not duplicative of completed or ongoing trials. * Innovation: Clearly articulate how the research challenges existing paradigms or incorporates novel collaborative or oversight strategies.

Compliance & Special Requirements

Regulatory Compliance & Ethical Standards

Federal Regulations: All awards are subject to the Code of Federal Regulations, particularly 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), and the NIH Grants Policy Statement.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC). The DSMB should approve the protocol prior to submission to the single IRB.
FDA & DEA Compliance: For clinical trials involving investigational therapeutics, vaccines, or medical interventions (including natural products), applicants must contact the FDA prior to applying to determine if an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application is necessary. No award will be made until necessary FDA approvals (e.g., open IND/IDE or exemption letter) are in place. If the product is on the DEA controlled substance list, necessary DEA licenses and registrations must also be in place prior to award.
Human Subjects Protections: Strict adherence to regulations enhancing protections for pregnant women, human fetuses, neonates, children, and prisoners. The Inclusion Across the Lifespan policy requires inclusion of individuals of all ages, women, and minorities unless scientifically or ethically justified.
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws.

Data & Technology Requirements

Data Management and Sharing: A Data Management and Sharing Plan is required for all applications that generate scientific data. Recipients must adhere to this plan.
Data Protection & Privacy: Applications must describe methods to protect participant confidentiality that meet data security standards for collecting, transferring, and accessing individual-level data remotely.
Health IT Standards: If the award involves implementing, acquiring, or upgrading health IT, recipients must use health IT that meets standards in 45 CFR part 170, Subpart B, and, for certain clinicians, is certified under the ONC Health IT Certification Program.
Cybersecurity: For recipients accessing HHS information or systems, plans modeled after the NIST Cybersecurity Framework are required to protect HHS systems and data.

Unique Aspects & Strategic Opportunities

Fully Remote Design is Mandatory: The most unique and critical aspect is the strict requirement for fully remotely delivered and conducted clinical trials with absolutely no in-person contact between research staff and participants. This demands robust preliminary data and expertise in remote methods.
High Programmatic Priority: Applications that address specific NCCIH high-priority topic areas (detailed in the 'Scope and Focus' section, e.g., symptom management, health disparities, specific mind-body or natural product research) will receive higher consideration.
Preliminary Data as a Barrier/Opportunity: The extensive preliminary data requirements can be a significant barrier for some applicants but represent a clear strategic advantage for those with a strong track record in remote clinical research.
Addressing Health Disparities: The grant explicitly encourages studies that examine the impact of integrating interventions into relevant settings to reduce health disparities, which is a key cross-cutting theme.
Innovation: There's an emphasis on applications that challenge existing paradigms or leverage novel collaboration/oversight strategies, suggesting a preference for innovative approaches within the remote clinical trial framework.
Risk Mitigation: Applicants are expected to outline contingency plans for potential delays or issues during implementation, and the independent Data and Safety Monitoring Board (DSMB) provides ongoing oversight of the trial's progress and participant safety.

Grant Details