Applications are evaluated for scientific and technical merit with an overall impact score reflecting the project's likelihood to exert a sustained, powerful influence on the research field.
Factor 1: Importance of the Research
- Significance:
- Addresses an important gap in knowledge, solves a critical problem, or creates a valuable conceptual/technical advance.
- Rationale for the study and rigor of scientific background justify the proposed work.
- Innovation:
- Applies novel concepts, methods, or technologies, or uses existing ones in novel ways.
- Specific to this NOFO: Strength of design to validate or reject the neural target or device being tested; readiness for the proposed phase of testing; strong, well-supported rationale.
Factor 2: Rigor and Feasibility
- Rigor:
- Potential to produce unbiased, reproducible, robust data.
- Rigor of experimental design and appropriate controls.
- Sufficient and well-justified sample size.
- Quality of plans for analysis, interpretation, and reporting.
- Adequate plans to address relevant biological variables (e.g., sex, age).
- For human subjects/vertebrate animals: rigor of intervention, justified outcome variables, generalizability, sample appropriateness and diversity, adequacy of inclusion plans.
- Feasibility:
- Proposed approach is sound and achievable; plans to address emerging problems.
- For human subjects: adequacy and feasibility of recruitment and retention plan for diverse participants; likelihood of achieving enrollment goals.
- For clinical trials: feasibility of study timeline and milestones.
- Specific to this NOFO: Information on specific regulatory pathway (e.g., IDE), clear and feasible plan for regulatory requirements (e.g., Q-submission, FDA approval plans);
- Go/no-go milestones are quantitative, clear, and achievable within the 2-year UG3 period.
- UG3 design moves intervention appropriately to UH3 phase.
- For UG3 target engagement studies: rigorous test using reliable, objective, and valid measures.
- UH3 phase provides a focused study to move the intervention forward, collecting sufficient data for neuronal target validation (relationships between target engagement, brain function, symptom/functional effects).
- Investigative team has sufficient methodological and statistical expertise.
Factor 3: Expertise and Resources
- Investigator(s):
- Demonstrated background, training, and expertise relevant to career stage and proposed work.
- For MPI applications: quality of leadership plan for coordination and collaboration.
- Environment:
- Institutional resources are appropriate for successful project execution.
- Specific to this NOFO: Sufficient evidence that investigators can work as a team; environment supports timely subject recruitment and completion of both UG3 and UH3 phases.
Additional Review Criteria (not separately scored, but contribute to overall impact)
- Protections for Human Subjects: Justification for involvement, protection against risks, potential benefits, importance of knowledge gained, data and safety monitoring.
- Vertebrate Animals: Description of procedures, justifications for use, interventions to minimize discomfort, justification for euthanasia methods.
- Biohazards: Assessment of hazardous materials/procedures and proposed protection.
- Resubmissions: Committee evaluates current application, considering responses to previous comments and changes made.
- Revisions: Appropriateness of proposed scope expansion; adequacy of responses to previous comments and evident substantial changes if related to previously unapproved lines of investigation.
- Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
- Budget and Period of Support: Justification and reasonableness of budget and requested period relative to research.
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