Precision Imaging of Oral Lesions (R01- Clinical Trial Not Allowed) | PAR 18 787

Frequently Asked Questions (FAQs): Precision Imaging of Oral Lesions (R01 - Clinical Trial Not Allowed)

What is this funding opportunity?

Precision Imaging of Oral Lesions (R01 - Clinical Trial Not Allowed) is an NIH discretionary research grant opportunity (Funding Opportunity Number PAR-18-787) focused on advancing imaging tools and methods for diseases and abnormalities of the oral cavity and oropharynx.

What is the main goal of PAR-18-787?

The central goal is to move oral and oropharyngeal imaging forward by supporting research that produces accurate and reproducible imaging results with strong sensitivity and specificity. In practical terms, the FOA aims to help clinicians and researchers better detect, characterize, treat, and monitor oral and oropharyngeal lesions.

What kinds of problems is this FOA trying to solve?

The announcement targets real-world challenges in distinguishing normal from diseased tissue, identifying high-risk lesions earlier, guiding treatment decisions, and tracking treatment response over time using imaging approaches that are reliable and clinically meaningful.

What does "precision imaging" mean in the context of this FOA?

Based on the FOA description, "precision imaging" refers to imaging methods and tools that provide accurate, reproducible outputs and that can meaningfully support clinical or research decisions, particularly through strong sensitivity and specificity in identifying or characterizing lesions.

What grant mechanism is used for this opportunity?

This opportunity uses the NIH R01 mechanism, which is designed to support substantial, hypothesis-driven research programs capable of generating rigorous evidence about how an imaging approach performs and why it is useful.

What types of projects are considered responsive to the FOA?

Projects aligned with the FOA typically include improving technical performance of imaging methods, establishing reliability across operators and settings, refining or validating imaging approaches for oral and oropharyngeal use, and demonstrating that imaging readouts are clinically meaningful for diagnosis and management.

Does the FOA support development of new imaging technologies?

Yes. The FOA emphasizes the full pipeline of imaging development, including the creation of new technologies as well as adaptation, optimization, refinement, and validation of existing technologies for use in the oral cavity and oropharynx.

Does the FOA support adapting existing imaging tools for oral and oropharyngeal use?

Yes. The opportunity explicitly includes adaptation and optimization of existing imaging methods for oral and oropharyngeal applications, especially where improvements in performance, robustness, or clinical relevance can be demonstrated.

What does "Clinical Trial Not Allowed" mean for applicants?

It means applicants should not propose studies that meet the NIH definition of a clinical trial, such as prospectively assigning human participants to interventions to evaluate health-related outcomes. Applications must be structured to stay outside the NIH clinical trial definition.

Are any human studies allowed under this FOA?

The FOA description indicates that certain non-clinical-trial human research may still be feasible, such as observational human studies, use of existing specimens or existing data, and technology development that does not involve assigning participants to an intervention. The key constraint is avoiding study designs that meet NIH's clinical trial definition.

Can a proposal include treatment monitoring?

Yes, the FOA highlights treatment monitoring as a target use case for imaging methods (for example, tracking how well treatments are working over time), as long as the study design remains outside NIH's clinical trial definition.

What is meant by sensitivity and specificity in this FOA?

The FOA emphasizes imaging tools and methods that can deliver strong sensitivity and specificity. In context, this means the imaging approach should reliably detect disease when present (sensitivity) and reliably indicate normal tissue when disease is absent (specificity), supporting accurate clinical or research interpretation.

What kinds of evidence does the FOA appear to value?

Based on the description, the FOA values rigorous evidence that an imaging approach is accurate, reproducible, and robust across operators and settings, and that the resulting imaging readouts are clinically meaningful for diagnosis and management decisions.

Who is eligible to apply?

Eligibility is broad and includes many organization types, such as various levels of government (state, county, city/township), special district governments, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized tribal governments, public housing authorities/Indian housing authorities, nonprofits with and without 501(c)(3) status, for-profit organizations other than small businesses, and small businesses.

Are minority-serving institutions eligible?

Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, and Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. The FOA specifically notes faith-based or community-based organizations among eligible applicant types.

Are federal agencies eligible to apply?

Yes. The FOA notes eligible agencies of the federal government as eligible applicants.

Are U.S. territories or possessions eligible to apply?

Yes. The FOA includes U.S. territories or possessions among eligible applicant types.

Can non-federally recognized tribal governments apply?

Yes. The FOA indicates that certain tribal governments that are not federally recognized are included among eligible applicant types.

Can foreign (non-U.S.) organizations apply?

Yes. The FOA states that non-domestic (non-U.S.) entities (foreign organizations) may apply.

What agency is issuing this opportunity?

The opportunity is issued by the National Institutes of Health (NIH).

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is PAR-18-787.

What funding activity areas is this opportunity associated with?

The FOA is categorized under education and health-related funding activity areas.

What CFDA program numbers are associated with this opportunity?

The record lists CFDA program numbers 93.121, 93.286, 93.393, 93.394, and 93.395.

When was this opportunity created, and what is the closing date shown?

The record provided indicates a creation date of May 16, 2018, and an original closing date of September 7, 2021.

Does the provided information include an award ceiling or number of awards?

No. The excerpt does not list an award ceiling or the expected number of awards.

How are budgets and project periods expected to work for this opportunity?

The excerpt notes that the overall structure is consistent with an NIH R01 mechanism, where budgets and project periods are typically justified by the scope of work and assessed through NIH peer review and institute-specific funding considerations.

What is the overall takeaway about the purpose of this FOA?

This is a targeted NIH research grant call aimed at strengthening precision imaging capabilities for oral and oropharyngeal lesions, prioritizing robust and validated methods that are clinically relevant while remaining within a non-clinical-trial research framework.