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Grant Analysis

Purpose & Target

This grant opportunity, PAR-25-254, is seeking mechanistic research to understand how and why expectancy effects occur in the context of cancer symptom management. The core objective is to leverage these effects to improve cancer outcomes and reduce health disparities, particularly for populations historically underrepresented or excluded from biomedical and behavioral research. This is a SECTOR-SPECIFIC grant, focused on cancer research and behavioral science related to health outcomes. It targets a broad range of organizational types, including higher education institutions, non-profits, for-profit organizations (including small businesses), and various government entities, both domestic (US) and international (non-U.S.). This is a recurring funding opportunity, reissued from a previous program, indicating ongoing commitment to this research area.

Financial Structure

Budget and Funding

Budget Range and Limitations: Application budgets are not limited by a set maximum or minimum. Applicants should propose a budget that accurately reflects the actual needs of their proposed project. This provides significant flexibility for projects with varying scopes and resource requirements.
Direct Costs: If the application requests $500,000 or more in direct costs in any single year (excluding consortium F&A), applicants must contact a Scientific/Research Contact at least 6 weeks prior to submission.

Cost Sharing and Co-financing

Matching Funds: This funding opportunity does not require cost sharing or matching funds as defined by the NIH Grants Policy Statement.

Eligible and Ineligible Costs

Specific eligible and ineligible costs are not detailed in this NOFO, but general Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Financial Reporting and Audit Requirements

Financial Reporting: Recipients are required to submit annual Research Performance Progress Reports (RPPR) and financial statements as per the NIH Grants Policy Statement.
Closeout: A final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are necessary for award closeout.
Audits: Awards are subject to the cost principles and audit requirements outlined in 2 CFR Part 200, which implies standard federal audit expectations.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types: This grant is highly inclusive, welcoming applications from a wide array of organizations:
- Higher Education Institutions: Public/State Controlled and Private Institutions.
- Nonprofits: Both with and without 501(c)(3) IRS status.
- For-Profit Organizations: Including Small Businesses and other For-Profit entities.
- Government Entities: Local (State, County, City or Township, Special District), Indian/Native American Tribal Governments (Federally Recognized and Other), and Eligible Agencies of the Federal Government (U.S. Territory or Possession).
- Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, and Regional Organizations.
- International: Non-domestic (non-U.S.) Entities (Foreign Organizations) are explicitly eligible to apply, and foreign components of U.S. organizations are also allowed.

Required Registrations All applicant organizations must complete and maintain active registrations prior to application submission. This process can take 6 weeks or more, so early initiation is crucial.

System for Award Management (SAM): Required for all applicants. It requires annual renewal.
NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations, in lieu of a CAGE code, to register in SAM.
Unique Entity Identifier (UEI): Issued through the SAM.gov registration process. The same UEI must be used across all registrations and the application.
eRA Commons: Organizations must register and have at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Requires an active SAM registration to complete.

Individual Eligibility (Program Director/Principal Investigator)

Any individual with the necessary skills, knowledge, and resources to conduct the proposed research may serve as a PD/PI. For multiple PDs/PIs, specific NIH policies apply.
All PD(s)/PI(s) must have an eRA Commons account and affiliate it with the applicant organization.

Exclusion Criteria The following types of projects are not responsive to this funding opportunity and will not be reviewed:

Projects that consider expectancy/expectancy effects only as an endpoint.
Projects that propose a Randomized Controlled Trial (RCT) that does not take an experimental medicine approach.
Studies that involve interventions without examining mechanisms and/or moderators.
Studies that include a deceptive placebo condition.

Application Process

Application Submission Deadlines This opportunity features multiple application due dates. Applicants are strongly encouraged to submit early to allow time for error correction.

February 05, 2025
June 05, 2025
October 05, 2025
February 05, 2026 (latest deadline)

All applications are due by 5:00 PM local time of the applicant organization. If a due date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day. Submission Method Applications must be submitted electronically using one of the following systems:

NIH ASSIST system: For online preparation, submission, and tracking.
Institutional System-to-System (S2S) solution: Check with your institutional officials for availability.
Grants.gov Workspace: For preparing and submitting your application.

After submission, applicants must track the status of their application in eRA Commons. Required Documentation and Materials Applicants must adhere to the instructions in the Research (R) Instructions in the How to Apply - Application Guide and any program-specific instructions in this NOFO. Key components include:

SF424(R&R) forms: Covering cover, project/performance sites, other project information, senior/key person profile, and budget (R&R or Modular).
PHS 398 forms: Including Cover Page Supplement and Research Plan.
Research Strategy: Must clearly address Factor 1 (Importance of the Research), Factor 2 (Rigor and Feasibility), and Factor 3 (Expertise and Resources) as detailed in the evaluation criteria.
Resource Sharing Plan: Required for all applicants.
Data Management and Sharing Plan: Required for all applicants planning research that generates scientific data, regardless of direct costs requested. This must be addressed in the application.
PHS Human Subjects and Clinical Trials Information: Required if human subjects are involved, including Study Record or Delayed Onset Study records. This grant specifically requires a clinical trial.
Appendix: Limited materials are allowed; generally, only blank questionnaires or surveys.

Project Duration

The maximum project period is 5 years.

Reporting Obligations

Annual Reporting: Recipients must submit the Research Performance Progress Report (RPPR) annually.
Post-Award Monitoring: NIH will review and measure performance based on details and outcomes shared within the RPPR.

Evaluation Criteria

Applications are evaluated for their scientific and technical merit through a rigorous NIH peer review system. Reviewers assign an Overall Impact Score based on the likelihood of the project to significantly influence the research field. This score is primarily driven by three Scored Review Criteria:

Factor 1. Importance of the Research (Significance and Innovation):
- Significance: How well the project's framework and design support future translational potential for improving cancer symptom management outcomes in clinical settings.
- Innovation: The project's ability to generate mechanistic knowledge about expectancy processes affecting cancer symptoms and their management, including leveraging novel theoretical concepts and methodologies from expectancy and related psychological processes.
Factor 2. Rigor and Feasibility (Approach):
- Approach: Clarity and justification for the selected patient population(s), cancer and treatment type(s), care setting(s), and symptom(s). Consideration of populations with the largest symptom burden, plans to oversample/exclusively sample underrepresented/medically underserved groups, or otherwise address disparities in cancer symptom management. Demonstration of an experimental medicine approach and a strategy for examining mechanisms and/or moderators of expectancy effects at multiple levels (e.g., physiological, psychological, interpersonal, environmental, structural).
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Investigator(s): Assessment of whether the investigative team includes necessary expertise, such as medical staff (MD or specialized oncology nursing staff), cancer symptom management, biobehavioral processes, psychological science, and health disparities.

Additional Review Criteria Reviewers also consider these factors, which influence the overall impact score but do not receive separate criterion scores:

Protections for Human Subjects: Ensuring ethical treatment and safety of participants.
Vertebrate Animals: If applicable, adherence to guidelines for animal research.
Biohazards: Management of potential biological hazards.
Resubmissions/Renewals/Revisions: Evaluation of previous progress or appropriateness of proposed changes.

Additional Review Considerations These items are considered but do not contribute to the overall impact score directly:

Authentication of Key Biological and/or Chemical Resources: Plans for validating resources.
Budget and Period of Support: Justification and reasonableness of the requested budget and project duration in relation to the proposed research.

Compliance & Special Requirements

Regulatory and Policy Compliance

Federal Regulations: All awards are subject to 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) and the NIH Grants Policy Statement.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws, affirmed during SAM.gov registration, and submit an Assurance of Compliance (HHS-690).
Statutory Compliance: Adherence to all federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements.

Data Protection and Security

Data Management and Sharing Plan: A comprehensive plan is required for all research generating scientific data. Recipients must implement the approved plan.
Cybersecurity: For recipients with ongoing access to HHS information/systems or handling PII/PHI from HHS, plans and procedures modeled after the NIST Cybersecurity framework are required to protect systems and data.

Ethical and Clinical Standards

Human Subjects Protection: Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all protocols. NIH must receive copies of documents related to major changes in ongoing protocols.
Data and Safety Monitoring: Required for all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure participant safety and data integrity.
Investigational New Drug (IND) / Investigational Device Exemption (IDE): Clinical research involving investigational therapeutics, vaccines, or devices must be performed under FDA IND or IDE, if applicable.
ClinicalTrials.gov: If an award funds one or more clinical trials, the responsible party must register and submit results for applicable clinical trials on ClinicalTrials.gov. NIH expects registration and reporting for all trials.

Technology Specifications

Health IT Standards: If funding involves implementing, acquiring, or upgrading health IT, it must meet standards and specifications adopted in 45 CFR part 170, Subpart B. For eligible clinicians in ambulatory settings or hospitals, certified technology under the ONC Health IT Certification Program should be used if applicable.

Mandatory Disclosure

Recipients or subrecipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award, as per 2 CFR 200.113.

Special Considerations and Unique Aspects

Clinical Trial Required: This is a hard requirement; only applications proposing clinical trial(s) will be accepted.
Focus on Expectancy Effects: Research must specifically aim to understand how and why expectancy effects occur and how they can be leveraged in cancer symptom management. These are beliefs about future outcomes related to cancer/treatment, evoked by various factors (social, psychological, environmental, systemic).
Experimental Medicine Approach: Projects are required to employ this approach, which involves identifying target mechanisms (expectancies), appropriate and validated measures of change in those mechanisms, and specific outcomes (cancer symptom(s)) that should change.
Underrepresented Populations: A strong interest exists in applications that enroll individuals and groups from populations historically underrepresented or excluded from biomedical and behavioral research, or medically underserved populations, to address health disparities.
Annual Meetings: Investigators should budget for annual grantee meetings on or near the NIH Campus in Bethesda, Maryland, to share research methods and findings. Collaboration and incorporating common data elements are encouraged.

Grant Details