On the Road to NIH SBIR/STTR Success- Increasing the Rigor

On the Road to NIH SBIR Success- Increasing the Rigor of Your Application

The credibility of the results from scientific research depends on how carefully and rigorously the experiments were performed. For NIH SBIR grant awards, the NIH has taken steps to increase the scientific rigor of the research that it supports with specific guidelines for the research application and review procedure. The agency considers scientific rigor as the use of methods to ensure “robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results.” Aspects of the ‘Research Strategy’ section of NIH SBIR/STTR applications that address rigor are evaluated by reviewers and incorporated into the overall impact score. Below are some suggestions where you can demonstrate rigor in your application and increase the likelihood of an improved score.

Build on a Strong Research Foundation

The Research Strategy ‘Significance’ section explains how the proposed work builds on previous studies and what new findings are expected. The rationale for focusing on the research topic likely references earlier work that may or may not be published. As the quality of this previous work impacts the strength of the conclusions, applicants need to provide a gauge of the strengths and weaknesses of earlier experiments.

Any weaknesses of key support work highlighted in the ‘Significance’ section should be addressed by the proposed work described in the Research Strategy ‘Approach’ section. Experiments should be described in sufficient detail, including the sample size and how many replicates will be analyzed to allow reviewers to evaluate the level of rigor. The use of statistical methods including a power analysis to ensure adequate sample size and appropriate analytical comparisons can enhance data quality. Blinded assessments can minimize investigator bias. For studies involving vertebrate animals or humans, sex as a biological variable should be incorporated into the experimental design.

Both the Significance and Approach are part of the Scored Review Criteria and will be incorporated into an overall impact score.

Check Your Reagents

Confirmation of the identity of biologic and chemical resources contributes to scientific rigor by minimizing the effect of reagents that may be variable. The attachment ‘Authentication of Key Biological and/or Chemical Resources’ requires a description (a 1-page limit is suggested) of methods to validate the identity or purity of these items. Key Resources are those that can differ from laboratory to laboratory or change over time, have qualities that can influence research data and are integral to the proposed work. Reagents and cell lines should be purchased from reputable vendors, and Material Safety Data Sheets and catalog number/lot number analytical sheets stored for future reference. Cell lines can be authenticated using short tandem repeat (STR) markers to establish a genetic profile for comparison with a reference standard. Cell lines can be periodically tested for mycoplasma contamination. Animals or cells with genetic modifications can be documented by DNA sequencing or PCR. The identity of chemicals can be verified by analytical methods such as LC/MS. Note that this section does not include authentication of newly generated biological/chemical resources; those validation methods belong in the Research Strategy ‘Approach’ section.

This document is not part of the Scored Review Criteria for NIH SBIR grants, but reviewers are asked to comment on these plans.

Digging Deeper

Excerpts from awarded submissions can effectively demonstrate aspects of scientific rigor. The NIH has provided several useful sites (listed below) with such examples along with guidance, training, and frequently asked questions (FAQs) about rigor and reproducibility in grant applications. The final site describes what reviewers are seeking in applications to evaluate rigor.

Work with Experts

A successful NIH SBIR grant application requires a significant amount of preparation time and careful navigation of a complicated process. Researchers at small business entities may have prior experience with academic grants, but there are distinct requirements for obtaining an SBIR/STTR award. Working with an experienced grant preparation contractor can help your company avoid common pitfalls, save valuable time, and access grant funds sooner.

For all of your Support Needs

ScienceDocs NIH SBIR Grant Writing and Editing

Useful Sources

Resources for Demonstrating Rigor (includes a link to Experimental Design Assistant, a free tool to help design robust experiments)

https://grants.nih.gov/policy/reproducibility/resources.htm

Guidance for Rigor and Reproducibility in NIH SBIR Grant Applications

https://grants.nih.gov/policy/reproducibility/guidance.htm

Video Training Modules for Rigor and Reproducibility

https://www.nih.gov/research-training/rigor-reproducibility/training

FAQs about Rigor and Reproducibility

https://grants.nih.gov/faqs – /rigor-and-reproducibility.htm?anchor=alphaHeader4056

Reviewer Guidance on Rigor and Transparency