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NIH RESEARCH GRANT APPLICATIONS : A HANDY GUIDE FOR APPLICANTS AND REVIEWERS

If you have ever tried to figure out the US National Institutes of Health (NIH) process to review applications for approval and funding, you will find yourself bouncing between multiple landing pages and attachments. We have prepared the following guide to make NIH research grant applications easier for both applicants and reviewers to fathom.

The NIH scoring system is from 9 (weak) to 1 (extremely strong) in 6 different domains:

  • What is the expected overall impact?
  • What is the significance of this study?
  • Who are the investigators?
  • How would this study would be innovative?
  • What is the research approach?
  • What is the research environment?

NIH research grant applications that score 5 or higher are rarely considered further.

Overall Impact

nih research grant applicationsAn overall rating is given by the review team based upon expected overall impact of this research. The assigned review leader will create a short summary of what he/she considers the overall impact, and his/her overall impact score. Assigned reviewers share their scores and the factors they each considered. This summary succinctly informs others of the underlying rationale or assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

  • Likelihood (i.e., probability) is primarily derived from the investigator(s), approach and environment criteria.
  • Sustained powerful influence is primarily derived from the significance and innovation criteria.
  • Research field(s) may vary widely, so it would be helpful if reviewers identify the research field(s) they believe will be influenced by each project.

 

Significance

nih research grant applicationsSignificance assumes that the aims of the research project are achieved and/or will be successfully completed. The section on significance should answer the following questions:

  • Does the research project address an important problem or a critical barrier to progress in the field?
  • If the aims of the research project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
  • How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Significance of the project needs to be explained within the context of a (research) field(s). For example, atrial fibrillation (AFib) is a significant field of study, but not all studies on AFib are significant. Moreover, research field(s) may vary widely, so it would be helpful to identify research field(s) within which the project addresses an important problem or critical barrier to progress. The research field may be focused on a specific basic research area (e.g. epidemiology) or a specific disease (e.g., paroxysmal AFib), or may be more broadly defined to cut across many health issues (e.g., need for patient involvement to assess impact of paroxysmal, persistent or permanent AFib on quality of life and other health technology assessment of burden of disease).

 

Investigators

nih research grant applicationsThe credibility of the research team/investigators is explained by answering:

  • Are the PD/PIs, collaborators, and other researchers well-suited to the project?
  • If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training in real world evidence (RWE) and investigator-initiated research (IIR)? If inexperienced, are there others in the research team who are well established who can mentor them?
  • If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?
  • If the research project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

 

Innovation

nih research grant applicationsAny funded research should be in some way important to advancing the field of interest. The innovation does not have to be a new drug, but could be a new way to study some aspect of therapy, epidemiology of disease, or methods for patient involvement or health technology assessment, to name a few. Innovative studies satisfy the following questions:

  • Does the NIH research grant application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
  • Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?
  • Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

 

Approach

The aim of this section is to assure that the overall approach (strategy, methodology, and analyses) is well-reasoned and appropriate to accomplish specific research aims. This section may also address these questions:

  • Are potential problems, alternative strategies, and benchmarks for success presented?
  • If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
  • If the project involves human subjects and/or clinical research, are the plans to address the protection of human subjects from research risks, and the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children, justified in terms of the scientific goals and research strategy proposed?

 

Environment

nih research grant applicationsThe environment refers to the institution or organization where the research project will be done. This section needs to answer:

  • Will the scientific environment in which the work will be done contribute to the probability of success?
  • Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?
  • Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

for more information

Mock NIH Study Section Grant Proposal Review Edited

Insider’s Guide to NIH Peer Review for New Reviewers

NIH Tips for Applicants

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