Tobacco Regulatory Science Program

TRSP Application Review Criteria

Note that the TRSP review criteria for Significance and Innovation below are different from the standard NIH review criteria.

TRSP encourages research applications that address the program’s research priorities to inform FDA regulation of products.

All applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the scored review criteria (significance, investigator(s), innovation, approach, environment for research) and additional review criteria (as applicable for the project proposed).

TRSP Application Review Criteria for Significance and Innovation

Use this decision tree to determine whether your study is a clinical trial.

 

Significance

Innovation

Non-Clinical Trials
    • Does the project address an important issue or a critical barrier in the field?
    • Is there a strong scientific premise for the project?
    • If the aims of the project are achieved, how will scientific knowledge and/or technical capability be improved?
    • How will successful completion of the aims affect the concepts, methods, and technologies related to the manufacture, distribution, and marketing of tobacco products?
    • Does the application challenge and seek to shift current research in the field of tobacco science as it relates to the manufacture, distribution, and marketing of tobacco products?
    • Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed?
    • Will the outcomes of the project provide new information to further develop the knowledge base that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?

    Clinical Trials
      • Are the scientific rationale and need for a clinical trial to test the proposed hypothesis well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
      • For trials focusing on public health endpoints, is this clinical trial necessary for testing the safety, efficacy, or effectiveness of the concepts, methods, and technologies that could inform the manufacture, distribution, and marketing of tobacco products in order to protect public health?
      • For trials focusing on behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding that could help inform the manufacture, distribution, and marketing of tobacco products in order to protect public health?
      • Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information, or potential to advance scientific knowledge that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?

       

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