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Grant Analysis

Purpose & Target

This grant, a Cooperative Agreement (U01) from the National Institute on Deafness and Other Communication Disorders (NIDCD), aims to fund investigator-initiated clinical trials in communication disorders. The core objective is to identify and advance effective interventions for conditions related to hearing, balance, smell, taste, voice, speech, and language, ultimately moving them into standard clinical care. This is a SECTOR-SPECIFIC grant focusing on healthcare research. It targets a wide range of U.S.-based organizations capable of conducting rigorous clinical trials, especially those requiring FDA oversight, establishing formal efficacy, involving higher risks, or having annual direct costs of $700,000 or more. The grant is offered through multiple application cycles over several years, indicating a recurring program.

Financial Structure

Budget and Limitations

Application budgets are not limited and should reflect the actual needs of the proposed clinical trial.
While there is no strict upper limit, clinical trial applications exceeding $700,000 or more in annual direct costs may be specifically routed to this funding opportunity (U01).

Eligible and Ineligible Costs

Funds will be provided to the award recipient for the human subjects research component of the clinical trial on a capitation basis (meaning per participant or unit) as per approved budgets.
Pre-award costs are generally allowable only as described in the NIH Grants Policy Statement.

Matching Fund and Cost-Sharing

This funding opportunity does not require cost sharing as defined by NIH policy.

Payment Schedule and Mechanisms

Specific payment schedules are not detailed in this document, but funds are disbursed by the designated HHS payment system or office after a Notice of Award (NoA) is issued.

Financial Reporting and Audit Requirements

Recipients will be required to submit financial statements as per NIH Grants Policy Statement reporting requirements.
A final Research Performance Progress Report (RPPR) and expenditure data from the Federal Financial Report are required for award closeout.
NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices, including integrity, ethics, and performance in managing federal awards.

Eligibility Requirements

Eligible Organizations This grant is open to a broad range of U.S.-based organizations. Non-U.S. organizations are not eligible to apply, nor are non-U.S. components of U.S. organizations. However, foreign components (as defined by NIH policy) are allowed within a U.S. applicant's project. Eligible types include: * Higher Education Institutions: Public/State Controlled and Private * Nonprofits: Both those with and without 501(c)(3) IRS status * For-Profit Organizations: Small Businesses and other For-Profit organizations * Local Governments: State, County, City/Township, Special District, and Indian/Native American Tribal Governments (Federally Recognized or Other) * Federal Governments: Eligible Agencies of the Federal Government and 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 Required Registrations All applicant organizations must complete and maintain active registrations in the following systems before submitting an application. This process can take 6 weeks or more, so early registration is crucial: * System for Award Management (SAM): Requires annual renewal. * NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations (in lieu of CAGE code) if foreign components are involved. * Unique Entity Identifier (UEI): Issued via SAM.gov registration. * eRA Commons: Organizations must have at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account. Obtaining an eRA Commons account can take up to 2 weeks. * Grants.gov: Requires an active SAM registration. Eligible Individuals (Program Director/Principal Investigator) Any individual with the necessary skills, knowledge, and resources to lead the proposed research can serve as a PD/PI. All PDs/PIs must have an eRA Commons account, affiliated with the applicant organization. Multiple PDs/PIs are allowed under NIH's policy.

Application Process

Application Submission Timeline Applications are accepted on multiple specific dates, with the latest final deadline being October 18, 2027, 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. Pre-Application Consultations

Letter of Intent (LOI): While not required or binding, submitting an LOI 30 days prior to the application due date is encouraged. This helps NIDCD staff estimate review workload.
Consultation with IC Staff: Strongly encouraged at least 10 weeks prior to the application due date. This helps determine if the proposed trial aligns with NIDCD's mission and priorities. It's required for applications requesting $500,000 or more in direct costs in any single year.

Application Process and Materials Applications must be submitted electronically via one of the following: * NIH ASSIST system * Grants.gov Workspace * An institutional system-to-system (S2S) solution Required application materials include, but are not limited to, the following forms and attachments (applicants must follow the Research (R) Instructions in the How to Apply - Application Guide and program-specific instructions in this NOFO): * Standard Forms (SF424(R&R) series): Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget. * PHS 398 Forms: Cover Page Supplement, Research Plan (including Resource Sharing Plan, Data Management and Sharing Plan), Human Subjects and Clinical Trials Information (including Study Record or Delayed Onset Study record). * Specific Attachments (as PDF files, with specified filenames): * FDA Documentation.pdf: Required if the study uses an FDA-regulated intervention, documenting IND/IDE status. * Trial Management Plan.pdf (max 5 pages): Only for multi-site clinical trials. Details how the trial will be managed, including roles, risk assessment/management, methodology, and processes for resolution and closure. * Data Quality Auditing Plan.pdf: Only for clinical trials Phase II, III, or IV. Describes independent auditing to verify compliance with protocol, SOPs, GCP, and regulations. * Post-trial Transition Plan.pdf: Describes anticipated long-term care needs for participants after the trial and a plan for care, considering various scenarios (e.g., intervention success/failure, regulatory decisions). Post-Award Requirements

Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required for multi-year awards. A final RPPR, invention statement, and expenditure data are needed for closeout.
ClinicalTrials.gov: Award recipients must register their clinical trial and submit results information on ClinicalTrials.gov prior to enrolling the first subject.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed and approved by their Institutional Review Board or Independent Ethics Committee.

Evaluation Criteria

Applications are evaluated for scientific and technical merit through a rigorous peer review system. The primary goal is to assess the project's potential to significantly influence the research field. Scored Review Criteria Reviewers will provide scores based on these three core factors: * Factor 1: Importance of the Research (Significance and Innovation): How crucial and novel is the proposed clinical trial? Does it address a significant problem in communication disorders? * Factor 2: Rigor and Feasibility (Approach): How well-designed, robust, and achievable is the proposed research plan? Are the methods sound and realistic? * Factor 3: Expertise and Resources (Investigator(s) and Environment): Does the research team have the necessary expertise, and is the environment (facilities, resources) adequate to successfully conduct the clinical trial? Additional Review Criteria (Considered for Overall Impact, Not Individually Scored) These aspects contribute to the overall evaluation but do not receive separate numerical scores: * Protections for Human Subjects: Assessment of how human subjects involved in the trial will be safely and ethically protected. * Vertebrate Animals / Biohazards: If applicable, plans for handling these will be reviewed. * Resubmissions / Renewals / Revisions: If the application is a resubmission, renewal, or revision, its responsiveness to prior feedback will be considered. * Recruitment and Retention Plan: Critically evaluated for efforts to engage appropriate and diverse populations, including strategies for community engagement to overcome participation barriers. Additional Review Considerations (Not Scored, Not for Overall Impact Score) These items are reviewed but do not directly influence the overall impact score: * Authentication of Key Biological and/or Chemical Resources: Plans for ensuring the validity of these resources. * Budget and Period of Support: Reviewers assess whether the requested budget and project duration are justified and reasonable for the proposed research scope.

Compliance & Special Requirements

Regulatory Compliance

FDA Oversight: Clinical trials requiring FDA oversight (e.g., Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications) are a primary focus. Applicants must provide official FDA documentation regarding the status of their intervention.
Human Subjects Protection: Strict adherence to ethical guidelines for human subjects research is mandatory, including review by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Federal Regulations: All awards are subject to U.S. Office of Management and Budget (OMB) administrative guidelines (2 CFR Part 200), HHS grant administration regulations, and NIH Grants Policy Statement.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws, as agreed upon during SAM.gov registration, and submit an Assurance of Compliance (HHS-690).

Data Management and Sharing

A comprehensive Data Management and Sharing Plan consistent with the 2023 NIH Policy is required. Applicants must outline how scientific data generated will be managed and shared.
For health IT activities, recipients must use technology meeting specific standards (45 CFR part 170, Subpart B) and, if applicable, certified under the ONC Health IT Certification Program.
Organizations handling Personal Identifiable Information (PII) or Personal Health Information (PHI) from HHS must develop cybersecurity plans and procedures modeled after the NIST Cybersecurity framework.

Project-Specific Requirements

Single Clinical Trial: Only one clinical trial may be proposed per application. Applications containing more than one clinical trial or other non-clinical trial studies will not be reviewed.
Clinical Trial Protocol: The protocol must be prepared using the Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies developed by FDA and NIH. It will be subject to NIDCD review and acceptance, and DSMB review.
Milestones Plan: Applications must include a detailed milestones plan for trial completion and contingency plans for potential delays. These milestones will be negotiated and incorporated into the award terms.
Recruitment and Retention: A plan to ensure the inclusion of women and minorities is required, with analysis of potential intervention outcome differences among sex subgroups. Innovative recruitment strategies, including community engagement, are crucial.

Cooperative Agreement Specifics

This is a 'cooperative agreement' mechanism, meaning substantial NIH programmatic involvement is anticipated. The NIDCD Project Scientist will actively assist, guide, coordinate, and participate in project activities. This goes beyond typical oversight.
While the recipient holds primary responsibility for the project, NIH staff will have shared responsibilities in managing broad clinical trial issues, have access to data, provide scientific/programmatic support, and review progress.
An independent Data and Safety Monitoring Board (DSMB) will be jointly established by the PI(s) and NIDCD. The DSMB will review interim results and report recommendations to the NIDCD Project Scientist.

Other Considerations

Intellectual Property: Recipients generally retain primary rights to data and software developed under the award, subject to Government access rights.
Mandatory Disclosure: Recipients must disclose any violations of federal criminal law (fraud, bribery, gratuity) potentially affecting the federal award.
Post-Submission Materials: Applicants must follow NIH guidelines for submitting materials after the initial application. (e.g., just-in-time information request prior to award).
Dispute Resolution: A formal process exists for resolving scientific or programmatic disagreements between award recipients and NIH.

Grant Details