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Grant Analysis

Purpose & Target

This grant encourages applications for the implementation of investigator-initiated, high-risk clinical trials, including associated mechanistic studies. The core objective is to advance understanding of human diseases and develop future therapeutic modalities related to infectious, immunologic, and allergic diseases. - Target Recipient: Organizations and institutions capable of conducting clinical trials, including universities, non-profits, for-profits (SME, enterprise), and various government entities. - Size: Not explicitly defined by employee count; capacity is determined by the ability to conduct complex clinical trials. - SECTOR-SPECIFIC: This grant is SECTOR-SPECIFIC. - Geographic Scope: Eligible to organizations globally (U.S. and non-U.S. entities). - Key Filtering Criteria: Must propose a single, high-risk clinical trial that aligns with NIAID's mission. Not for planning or non-high-risk trials. - Grant Frequency: Recurring, with multiple application deadlines through January 2027. This is a reissue of a previous funding opportunity.

Financial Structure

Budget: Application budgets are not limited but must reflect the actual needs of the proposed project.
Eligible Costs: Includes costs for clinical trial conduct, independent study monitoring, medical and data monitoring, regulatory submissions, quality management, safety oversight activities, investigational product costs (including labeling and distribution), and mechanistic studies (if applicable).
Cost Sharing: This funding opportunity does not require cost sharing.
Co-financing: If co-funding or in-kind support is planned from any source (non-NIH or NIH), letter(s) of commitment (type, amount, source) signed by a business official must be included in the Letters of Support section.
Indirect Costs: Policies outlined in the NIH Grants Policy Statement apply.
Financial Reporting: Recipients must submit financial statements as required by the NIH Grants Policy Statement.
Pre-award Costs: Allowable only as described in the NIH Grants Policy Statement.

Eligibility Requirements

Eligible Organization Types

UNIVERSITY: Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education
NGO: Nonprofits with or without 501(c)(3) IRS Status (other than Institutions of Higher Education)
SME: Small Businesses (For-Profit Organizations)
ENTERPRISE: For-Profit Organizations (other than Small Businesses)
PUBLIC: State Governments, County Governments, City or Township Governments, Special District Governments, Indian/Native American Tribal Governments (Federally Recognized and Other), 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, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations)

Geographic Location Requirements

Applicants can be from within the U.S. or from any non-U.S. country. Non-domestic (non-U.S.) components of U.S. Organizations are also eligible to apply.

Required Registrations and Certifications

System for Award Management (SAM): Must complete and maintain an active registration (renewable at least annually). Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
Unique Entity Identifier (UEI): Issued as part of the SAM.gov registration process. Must be the same UEI for all registrations and grant applications.
eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Applicants must have an active SAM registration to complete Grants.gov registration.

Project Specific Requirements

The proposed project must involve a clinical trial and be defined as 'high-risk' by NIAID (e.g., involves a non-routine intervention, an unlicensed product, or a licensed product for an unapproved indication, or requires regulatory oversight like IND/IDE).
Only one clinical trial may be proposed per application. Applications proposing more than one clinical trial will not be reviewed.
Clinical trial planning activities must be completed prior to application submission; investigators must be ready to implement the proposed trial at the time of award.
For DAIT-supported clinical trials, mechanistic studies must be included.

Application Process

Application Process Steps

Submission Method: Applications must be submitted electronically through NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Application Forms: Use the SF424(R&R) application package specific to this opportunity.
Letter of Intent (LOI): Encouraged, though not required or binding, 30 days prior to the application due date. Includes descriptive title, PD/PI names/contact, key personnel, participating institutions, and funding opportunity number/title.
Prior Consultation: Strongly encouraged with NIAID staff at least 10 weeks prior to submission. Required if the budget is $500,000 or more in direct costs for any year. Strongly encouraged at least 12 weeks prior if the budget is $1,000,000 or more in direct costs for any year.

Key Dates and Deadlines

Open Date (Earliest Submission): April 12, 2024
Latest Application Due Date: January 13, 2027 (by 5:00 PM local time of applicant organization). Multiple other deadlines exist before this date.
Expiration Date of NOFO: January 14, 2027
Latest Scientific Merit Review: February 2027
Latest Advisory Council Review: May 2027
Latest Earliest Start Date: July 2027

Required Documentation and Materials

SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
Budget: R&R or Modular Budget (detailed scientific and operational plans with funding needs for entire trial and data analysis period).
PHS 398 Forms: Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information.
Research Plan Components: Specific Aims, Research Strategy (overview of science, significance, preliminary data, bias discussion, GCP/GLP/GMP plans, oversight plans, study agent acquisition, ethical considerations, activities for conduct/completion/analysis, impediments/alternative approaches, platform trial details).
Letters of Support: For access to critical resources (consortium/site participants, cores, laboratories, pharmacies, data management), including commitment letters for co-funding.
Resource Sharing Plan: Required for generated resources.
Data Management and Sharing Plan: Required for all research generating scientific data.
Appendix Materials: Only limited materials allowed. Must include the complete Clinical Protocol (using NIAID Division-specific templates) and informed consent/assent forms.
Human Subjects and Clinical Trials Information: Study Record including Study Timeline (with milestones for regulatory approvals, enrollment percentages, data collection/analysis completion, final report), Protection and Monitoring Plans (Data and Safety Monitoring Plan, data management plan), Overall Structure of the Study Team.
Other Clinical Trial-related Attachments: Identification/qualifications of clinical trial site(s), pharmacies, labs; data collection forms/questionnaires; Investigator's Brochure; Table of Contents of Manual of Operations (MOPs); comprehensive Laboratory Plan; plans/support for study agent acquisition/administration; documentation of co-funding; documentation of communications with regulatory authorities.

Post-Award Requirements

Reporting: Annual Research Performance Progress Report (RPPR) and financial statements.
Closeout: Final RPPR, invention statement, and expenditure data portion of the Federal Financial Report.
ClinicalTrials.gov: Registration and results reporting for applicable clinical trials.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed by their IRB or Independent Ethics Committee.
Data and Safety Monitoring: Adherence to NIH policy for human biomedical/behavioral intervention studies.
IND/IDE Requirements: Compliance with FDA Investigational New Drug/Device Exemption requirements for investigational products.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the research field, considering all review criteria.

Scored Review Criteria (Given separate scores)

Significance: Does the project address important problems? How will the results impact the field or public health?
Investigator(s): Are the PD/PI(s) and team well-suited and appropriately trained? Do they have the necessary expertise and experience?
Innovation: Does the project challenge existing paradigms or develop new methodologies? Note: A clinical trial design may not be innovative per se but can still address important unmet needs.
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate? Are potential problems, alternative strategies, and benchmarks for success addressed? Is the human subjects involvement and data safety monitoring robust?
Environment: Does the project environment contribute to the probability of success? Are necessary resources available, and is there institutional support?

Additional Review Criteria (Considered, but not separately scored)

Study Timeline: Is the proposed timeline for the clinical trial, including milestones, feasible and justified?
Applications from Foreign Organizations: Does the project present special opportunities leveraging unique talent, resources, populations, or environmental conditions not readily available in the U.S. or that augment existing U.S. resources?
Select Agent Research: Assessment of plans for handling and security of select agents, if applicable.
Resource Sharing Plans: Reasonableness of plans for sharing resources or justification for not sharing.
Authentication of Key Biological and/or Chemical Resources: Adequacy of plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Justification and reasonableness of the budget and requested project period in relation to the proposed research.

Factors Considered in Funding Decisions (Post-Review)

Scientific and technical merit (as determined by peer review)
Availability of funds
Relevance of the proposed project to program priorities
Sufficiency of proposed budget to support the proposed research

Compliance & Special Requirements

Regulatory Compliance

Federal Regulations: Adherence to 42 CFR part 493.2 and 493.3(b)(2) for all clinical laboratory testing. Clinical research involving investigational products must comply with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
Good Practices: Implementation and monitoring of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP), as appropriate.
Data Management: Adherence to 21 CFR Part 11 for data management systems.

Data Protection and Privacy

Data Management and Sharing Plan: Required for all research generating scientific data, outlining how data will be managed, preserved, and shared.
Data Security: Data management plans must address security and emergency back-up for database systems.

Ethical Standards

Demonstrated consideration of ethical issues involving the disease/condition under study.
Strict compliance with human subjects protection regulations and policies, including IRB/IEC approval and data and safety monitoring.

Intellectual Property Policies

Recipients retain custody of and primary rights to data and software developed under the awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Risk Management

Projects must include plans for appropriate oversight over the conduct of the trial, including independent clinical monitoring, safety monitoring, regulatory submissions, and quality management.
Requires a Data Safety Monitoring Board (DSMB) or Safety Monitoring Committee (SMC), or the use of an NIAID-sponsored DSMB/SMC.

Unique Aspects and Challenges

Focus on High-Risk Trials: This NOFO specifically targets clinical trials defined as 'high-risk' by NIAID. Applicants must clearly demonstrate how their proposed trial meets this definition.
Cooperative Agreement: Substantial Federal scientific or programmatic involvement is anticipated. This means NIH staff will assist, guide, coordinate, or participate in project activities, with joint responsibilities shared between the recipient and NIAID.
Single Trial Requirement: Only one clinical trial is permitted per application, simplifying the focus but limiting broad programmatic approaches within a single award.
Pre-application Readiness: Planning activities must be complete and the investigator must be ready for trial implementation at the time of application, not just upon award.
Milestone Driven: Projects must delineate clear, scheduled milestones for major project stages, which will be negotiated at the time of award.

Strategic Alignment Opportunities

Strong alignment with NIAID's mission and high-priority research areas, including specific encouragement for HIV-related clinical trials that integrate biomedical and behavioral interventions, offers a strategic advantage.

Grant Details