Applications are evaluated for scientific and technical merit through NIH's peer review system. Clinical trial applications are assessed for addressing important questions/unmet needs, even if not innovative.
Overall Impact Score
- Reflects the likelihood of the project to exert a sustained, powerful influence on the research field(s).
Scored Review Criteria (each given a separate score)
- Significance:
- Addresses an important problem or critical barrier.
- Rigor of prior research supporting the project.
- Improvement of scientific knowledge, technical capability, and/or clinical practice.
- Potential to change concepts, methods, technologies, treatments, services, or preventive interventions.
- For clinical trials: Scientific rationale and need for the trial, justification of endpoints, necessity for advancing understanding or changing clinical practice.
- Investigator(s):
- Appropriateness of PD(s)/PI(s), collaborators, and other researchers for the project.
- Experience and training (especially for Early Stage Investigators).
- Demonstrated record of accomplishments (for established investigators).
- Complementary expertise, leadership, governance, and organizational structure for collaborative/multi-PD/PI projects.
- For clinical trials: Expertise in study coordination, data management, statistics; appropriate organizational structure for multicenter trials.
- Innovation:
- Challenges and shifts current research/clinical paradigms through novel concepts, approaches, methodologies, instrumentation, or interventions.
- Refinement, improvement, or new application of existing elements.
- For clinical trials: Innovative elements in design/research plan enhancing sensitivity, information potential, or scientific/clinical advancement.
- Approach:
- Well-reasoned strategy, methodology, and analyses appropriate for aims.
- Plans to address weaknesses in prior research rigor.
- Robust and unbiased approach strategies.
- Consideration of potential problems, alternative strategies, and benchmarks.
- Feasibility establishment and risk management for early-stage projects.
- Plans to address relevant biological variables (e.g., sex) in animal/human subjects studies.
- For human subjects/clinical research: Protection of human subjects, justification for inclusion/exclusion based on sex, race, ethnicity, and age.
- For clinical trials: Justified study design (clear, informative outcomes, powered for research question), ethical considerations, appropriate informed consent, eligible population availability, feasible recruitment/retention plans, randomization/masking justification, quality assurance, data management, and statistical analysis.
- Specific to this NOFO: Clearly defined and feasible timeline for enrollment, retention, and observation; feasible plan to link to independently funded TB treatment programs; metrics for enrollment evaluation and strategy modification; sufficiency of observation period; rigor of participant eligibility; availability and accessibility of clinical data (HIV status, Mtb drug susceptibility, TB treatment); availability of samples for pathology studies.
- Environment:
- Scientific environment's contribution to success.
- Adequacy of institutional support, equipment, and physical resources.
- Benefit from unique features (scientific environment, subject populations, collaborative arrangements).
- For clinical trials: Appropriateness of administrative, data coordinating, enrollment, and laboratory/testing centers; capability to conduct trial at proposed sites; appropriateness of plans for adding/dropping centers; addressing complexity for international sites; evidence of individual site ability for enrollment, protocol adherence, data collection, and operation within structure.
Additional Review Criteria (not scored but considered)
- Study Timeline (for clinical trials): Detailed, feasible timeline (start-up, enrollment, follow-up), incorporation of efficiencies, discussion of challenges and solutions.
- Protections for Human Subjects: Justification for involvement, adequacy of protection, potential benefits, importance of knowledge, data and safety monitoring.
- Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Proposed plans for inclusion/exclusion justified by scientific goals.
- Vertebrate Animals: Description of procedures, justification for use, interventions to minimize discomfort, justification for euthanasia.
- Biohazards: Assessment of potential hazards and proposed protection.
Other Review Considerations (not scored)
- Resubmissions: Evaluated based on responses to previous comments and changes made.
- Applications from Foreign Organizations: Assessed for special opportunities (unusual talent, resources, populations, environmental conditions) not readily available in the U.S. or augmenting existing U.S. resources.
- Select Agent Research: Assessment of agent use, registration status, monitoring procedures, biosafety, biocontainment, and security.
- Resource Sharing Plans: Reasonableness of plans or rationale for not sharing.
- Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
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