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Grant Analysis

Purpose & Target

The NIAID New Innovators Awards (DP2 Clinical Trial Not Allowed) aims to support exceptionally creative postdoctoral and newly independent Early Stage Investigators (ESIs). Its core objective is to fund novel, original, and insightful research concepts with the potential for major impact in biomedical research. - Target recipient type: Individual postdoctoral and newly independent Early Stage Investigators. - Target recipient size: Individuals who will transition to or are in their first year of an independent research position within a U.S.-based institution. - SECTOR-SPECIFIC: Focuses on biomedical research, specifically within the mission of NIAID (infectious, immunologic, and allergic diseases). - Geographic scope: Research must be conducted at a U.S.-based institution. - Key filtering criteria: Applicant's ESI status, novelty, creativity, and potential impact of the proposed research, alignment with NIAID's mission, and individual's progression to an independent research role. - Grant frequency: Recurring, with multiple application deadlines until its expiration date of October 11, 2025.

Financial Structure

Award budget is limited to $300,000 in direct costs per year.
The maximum project period is 5 years.
The total funding requested for the full project period should be $1,500,000 (calculated as 5 years x $300,000/year).
No non-federal funds are required, meaning $0 in matching funds or co-financing is explicitly mandated.
Detailed budgets and budget forms are not required with the initial application; they will be requested as 'Just in Time' information if the application is selected for funding.
Eligible costs include direct costs for the proposed research, including travel costs for the PD/PI to attend two required program meetings in the Bethesda, MD area.
Facilities & Administrative (F&A) costs will be requested at the 'Just in Time' stage.
Ineligible activities: Clinical trials and Human Fetal Tissue research are not allowed under this funding opportunity.
Financial reporting requires annual submission of the Research Performance Progress Report (RPPR). A final RPPR, invention statement, and expenditure data for the Federal Financial Report are required for award closeout.
No cost sharing is required by this funding opportunity.

Eligibility Requirements

Organizational Eligibility

Eligible organization types:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other)
Local Governments (State, County, City/Township, Special District, Indian/Native American Tribal)
Federal Government (Eligible Agencies)
Other (Independent School Districts, Public Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations)
Geographic location: Organizations must be U.S.-based institutions. Non-domestic (non-U.S.) entities are not eligible to apply. Non-domestic components of U.S. Organizations are not eligible. Foreign components (as defined by NIH) are allowed.
Required registrations: Applicant organizations must be registered and maintain active status in:
System for Award Management (SAM) with annual renewal.
Unique Entity Identifier (UEI), obtained through SAM.gov registration.
eRA Commons, with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov.

Individual Eligibility (Program Director/Principal Investigator - PD/PI)

Multiple PD(s)/PI(s) are not allowed.
Must be a postdoctoral, non-independent, or newly independent investigator (defined as being within the first year of a faculty position or equivalent at a U.S.-based institution at the time of application submission).
Must have Early Stage Investigator (ESI) status (defined as completed terminal research degree or end of post-graduate clinical training, whichever is later, within the past 10 years and not having previously competed successfully as PD/PI for a substantial NIH independent research award).
Must possess a research or clinical doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD, or equivalent doctoral degree), or a combined research and clinical doctoral degree.
Both U.S. and non-U.S. citizens are eligible to apply. However, at the time of award activation, the individual must be a U.S. citizen, a non-citizen national, lawfully admitted for permanent residence (Green Card holder), or a non-U.S. citizen with a valid visa that allows conducting and completing the proposed research at a U.S.-based institution.
Must commit a minimum of three person-months (25%) of their research effort each year to activities supported by the NIAID DP2 award.
Must hold an independent research position at a U.S.-based institution by the time of award activation. An 'independent research position' confers eligibility to apply for R01 grants with appropriate institutional commitment.
Postdoctoral applicants must transition to a faculty position or equivalent at a U.S.-based institution within one year in order to activate the award.
Newly independent applicants must be within the first year of a faculty position or equivalent at a U.S.-based institution at the time of application submission.
Individuals who have been, or currently are, the PD/PI of an NIH R03 or R21 grant or an equivalent non-NIH award are eligible.
Concurrent pending NIH R01 or equivalent grant applications are allowed, but if the R01 becomes active prior to the NIAID New Innovator Award, the applicant becomes ineligible for the DP2.
Concurrent pending NIH Research Career Development Awards are allowed if projects are not highly overlapping. However, NIAID New Innovator Recipients are not eligible for concurrent or subsequent mentored K or R00 awards; the DP2 cannot be awarded if such an award is active.

Exclusion Criteria

Projects involving clinical trials are not allowed.
Research involving Human Fetal Tissue is not allowed.
Applications with multiple PD(s)/PI(s) are not allowed.
Organizations located outside the U.S. are not eligible.

Application Process

Application Deadlines and Submission

Open Date (Earliest Submission Date): September 13, 2023.
Letter of Intent Due Date(s): 30 days prior to each application receipt date. Although not required or binding, applicants are asked to submit one.
Application Due Dates (latest first):
October 10, 2025
October 11, 2024
October 13, 2023
All applications are due by 5:00 PM local time of the applicant organization. Applicants are encouraged to apply early to allow time for corrections.
Expiration Date for the funding opportunity: October 11, 2025.
Submission Platform: Applications must be submitted electronically through NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.

Required Documentation and Materials

Follow instructions in the SF424 (R&R) Application Guide, supplemented by this NOFO.
SF424(R&R) Cover: Type of Application must be 'New'. Total Federal Funds Requested and Total Federal & Non-Federal Funds should be entered as $1,500,000 (5-year total).
SF424(R&R) Other Project Information: Attach 'Bibliography & References Cited.pdf' in the 'Other Attachments' section. Do not use the dedicated Bibliography & References Cited field.
SF424(R&R) Senior/Key Person Profile:
Only the PD/PI may serve as senior/key personnel.
Biographical Sketch: Must accurately reflect postdoctoral or newly independent status and Early Stage Investigator status.
Current and Pending Support: Attach a list from all sources.
PHS 398 Research Plan:
Specific Aims: Broad, long-range objectives; highlight new scientific direction and distinction from postdoctoral training.
Research Strategy: Discuss significance/impact, creativity of approach, how research promotes independence, risk management, and applicant's qualifications/potential for growth. Written for broadly knowledgeable reviewers.
Project Description and Approach: Describe scientific challenge, importance, major impact. Coherent strategy with rationale/hypothesis. Discuss creativity, originality, novelty, potential convergence of disciplines, and alternative plans. Detailed experimental plans and methods are not required.
Investigator Qualifications: Training, experience, specific contributions, originality/creativity. Discuss potential for growth and independence.
Suitability for the New Innovator Award program: Explain why it's uniquely suited to this award versus traditional grants.
Statement of Research Effort Commitment: Must state commitment of minimum three person-months (25%) effort.
Description of Institutional Environment: (up to 1 page) For non-independent applicants: describe needed facilities/resources/environment for research and career transition. For newly independent applicants: describe available facilities/resources/environment for research and continued growth.
Letters of Support:
- For postdoctoral/non-independent: A statement from the current mentor/supervisor indicating freedom to continue the proposed scientific approach outside the postdoctoral laboratory.
- All applicants: Individual letters (1-3) from current/prior mentors/supervisors discussing applicant's contributions to published work and qualities (imagination, depth of knowledge) relevant to the DP2 program.
Resource Sharing Plan: Comply with instructions.
Data Management and Sharing Plan: Required for applications due on or after January 25, 2023.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). No publications or other material.
PHS Human Subjects and Clinical Trials Information: If human subjects involved (clinical trials not allowed, but human subjects research may be), complete forms.
PHS Assignment Request Form: Complete as instructed.

Registration and Submission Process

Applicant organizations must complete SAM, UEI, eRA Commons, and Grants.gov registrations before the application due date. This can take 6+ weeks.
PD/PIs must have an eRA Commons account and link it to their organization.
Applications will be evaluated for completeness and compliance; incomplete or non-compliant applications will not be reviewed.
Applicants are responsible for viewing their application in eRA Commons before the due date to ensure successful submission.
Post-submission materials are allowed per NIH policy.

Evaluation Criteria

Overall Impact

Reviewers will provide an overall impact score reflecting the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria

Significance:
Does the project address an important problem or critical barrier?
Is prior research supporting the project rigorous?
How will scientific knowledge, technical capability, and/or clinical practice improve if aims are achieved?
How will successful completion change concepts, methods, technologies, treatments, services, or preventative interventions in the field?
Investigator(s):
Are the PD/PI, collaborators, and other researchers well suited to the project?
Do Early Stage Investigators (or those in early stages of independent careers) have appropriate experience and training?
How well does the application demonstrate the researcher's capability to think creatively, question paradigms, work with intellectual uncertainties, develop unique collaborations, integrate varied information, or develop novel approaches?
Innovation:
Does the application challenge and seek to shift current research or clinical practice paradigms using novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
Are the concepts, approaches, etc., novel to one field or broadly novel?
Is a refinement, improvement, or new application proposed?
Approach:
Are the overall strategy, methodology, and analyses well-reasoned and appropriate?
Are plans to address weaknesses in prior research rigor presented?
Are strategies for a robust and unbiased approach presented?
Are potential problems, alternative strategies, and benchmarks for success presented?
For early-stage projects, will the strategy establish feasibility, and are risky aspects managed?
Are plans for relevant biological variables (e.g., sex) adequate?
For human subjects research: Are plans for protection of human subjects and inclusion (or exclusion) justified?
Environment:
Will the scientific environment contribute to success?
Are institutional support, equipment, and physical resources adequate?
Will the project benefit from unique features, subject populations, or collaborations?
For non-independent applicants: How well are facilities, resources, and institutional research environment described to support proposed work and likelihood of success?
For newly independent applicants: How well are available facilities, resources, and institutional research environment described to support success?

Additional Review Criteria (not separately scored, considered for overall impact)

Protections for Human Subjects (if applicable).
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan (if applicable).
Vertebrate Animals (if applicable).
Biohazards (if applicable).

Additional Review Considerations (not scored, not considered for overall impact)

Resource Sharing Plans: Reasonableness of the plan or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Sufficiency of brief plans for validity.
Budget and Period of Support: Justification and reasonableness relative to proposed research.

Funding Decision Factors

Scientific and technical merit as determined by peer review.
Availability of funds.
Relevance to program priorities.
Potential for the investigator to lead research that may result in scientific breakthroughs of broad impact (despite inherent risks).
Unusually cross-cutting or significantly underrepresented science.

Compliance & Special Requirements

Regulatory Compliance

All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Award recipients must complete an HHS Assurance of Compliance form (HHS 690) agreeing to administer programs in compliance with federal civil rights laws (prohibiting discrimination based on race, color, national origin, age, sex, disability, and ensuring meaningful access for limited English proficiency individuals) and applicable conscience laws.
Awards are subject to Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.

Research-Specific Restrictions and Requirements

Clinical Trials are not allowed. Only applications that do not propose clinical trials will be accepted.
Research involving Human Fetal Tissue is not allowed.
A Data Management and Sharing Plan is required for all research generating scientific data (for applications due on or after January 25, 2023).
Resource Sharing Plans are required.
Plans for authentication of key biological and/or chemical resources are required.
Compliance with ethical standards for human subjects research, inclusion of diverse populations, use of vertebrate animals, and biohazard protocols (if applicable) is required.

Organizational and Individual Commitments

Recipient institutions must ensure that research protocols involving human subjects are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
For non-U.S. citizens with temporary U.S. visas, the applicant institution is responsible for determining and documenting that the PD/PI's visa status allows them to conduct and complete the proposed research in the U.S. for the award duration.
The PD/PI must commit a minimum of 25% (three person-months) of their research effort to the project annually.
The PD/PI must transition to or hold an independent research position at a U.S.-based institution by the time of award activation.

Special Considerations and Expectations

The grant encourages novel, original, and insightful research that proposes new scientific directions, unexpected convergence of disciplines, or the use of novel methodologies.
While preliminary data is not required, a strong rationale indicating the likelihood of success for proposed concepts is highly recommended.
Two program meetings will be held in the Bethesda, Maryland area over the project period. Award recipients are required to attend these meetings to foster collaborations, report progress, and seek new research directions.
The review process will emphasize the individual's distinct contributions, potential for new scientific directions, and the creativity and originality of the proposed research.

Grant Details