5 Major Mistakes in NIH SBIR Grant Writing

As we draw closer to the Cycle I deadline for SBIR (Small Business Innovation Research) grants to the National Institutes of Health (NIH), I wanted to share the 5 major mistakes small business concern (SBC) applicants make when writing an SBIR grant application to the NIH that costs them a revision cycle and funding. SBIR grant writing is time-consuming and a major investment. You don’t want to be rejected for mistakes you can fix prior to submission.

1. Focusing aims on commercialization and not research

In the world of NIH SBIR grant writing, your “Specific Aims” are your on-the-ground objectives – what you’d see accomplished at the 5000-foot level. Because SBC applicants specialize in developing and bringing to market medical devices, treatments, and drugs, etc., often I see specific aims drafted that are related to commercialization and not to research.

For example, if one of your specific aims is: “To produce 500 medical devices to do XYZ” that’s not a research aim. That is a commercialization aim. I’ve seen many worthy projects rejected for aims that are written in terms of commercialization and not research.

If you’re wondering how to write a specific aims page, one resource that can help you understand how to write research-oriented specific aims is the American Society of Transplantation’s Research Grant Writing Webinar. You can also contact us if you need assistance or review of your specific aims.

2. The budget doesn’t reflect the research aims

Just like with mistake #1, if your SBIR budget appears to be all devoted towards manufacturing with no data collection or analysis, or not properly justified as to why so much is spent on manufacturing, the reviewers will see it.

Also be careful to note the rules about budget spending on SBIR grants.

3. Failure to adequately address protections to human subjects

SBC applicants often fail to realize that NIH definitions of clinical trials differ from regulatory agencies like the FDA. Additionally, whether or not you are doing human subjects research is not dependent on whether or not you are conducting a clinical trial, regardless of any agency’s definitions.

4. Guessing at numbers

I don’t just mean estimating – estimating is an educated process of looking at an equation with different inputs and making a projection. No, I mean guessing. Specifically guessing where guessing does not work. An NIH research strategy without a sample size calculation will not score well in the scientific review criteria. A sample size calculation is a statistical calculation that takes into account effect sizes from previous studies, the primary outcomes defined in your study, and other confounding factors (yes, that’s a technical term) to estimate the number of people you need to recruit to participate in your study to actually demonstrate something scientifically.

It’s not uncommon to look at previous study with 100 participants and say “oh, we’ll get 100 participants.”  And that strategy will send your grant right to the bottom of the reject pile.

So make sure to work with a statistician to get the appropriate estimates. You can also try out some free sample size calculators, although these may or may not provide accurate results. And don’t forget to include a demographic breakdown of your sample population and justify that demographic breakdown. Very few studies recruit all the same race or age demographic, and you need to show how you’ll make sure you recruit a diverse demographic that is representative of the population you are studying.  

5. Poorly written biosketches

The review panel wants to see a strong scientific team. Biosketches that aren’t geared towards the FOA, that don’t illustrate how the team has the specific expertise to pull of the research study, and that don’t follow the formatting requirements will lead to a poor score. Poorly formatted biosketches can also result in administrative errors that preclude your grant from being reviewed at all!

The NIH recently changed the biosketch format, effective January 2022. You can learn more about how to write effective biosketches from the NIH FAQs.

These are the biggest mistakes, the ones that lead to an unfunded grant and a rejection summary statement, I see from clients who approach me to help them with resubmission of grants they submitted on their own.

Grant writing can be tricky, and if you want to avoid these mistake, consider having an expert review your grant before submission to give you feedback and suggestions.

Questions about how to write an SBIR grant? Additions to my list?

Leave a comment in the box.

Remember: if you’re not writing grants, you’re not winning them either.

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