What do you mean, NIH didn’t like my idea!@#%$%
The process of preparing an SBIR/STTR submission for NIH – or other government agency – is not for the faint of heart. It’s time consuming and complicated, but since it provides the opportunity to compete for perhaps millions of dollars of non-dilutive R&D funding, we think it’s worth it. That said, it’s a fact that most SBIR/STTR proposals are not funded–the funding rate at NIH varies by Institute or Center, but only about 10-15% of Phase I’s typically are funded each submission.
After all the preparation, not getting funded is a huge disappointment. However, after you’ve taken some deep, cleansing breaths to get over the initial incredulity (and perhaps, downright fury!), you need to assess your next steps. NIH allows applicants to resubmit unsuccessful Phase I or Phase II proposals once within 37 months after the first application’s receipt date, so before throwing in the towel you should give serious consideration to that opportunity. Here’s how to get started:
- Evaluate your summary statement Read it carefully – and calmly – and try to see what the reviewers saw. Can you fix the problems they cited and/or clarify points of misunderstanding? If you address all of the issues they point out, will a re-submission be viewed more favorably – or was enthusiasm for the project generally too low for resuscitation?
- Contact your Program Officer This is the person who will be able to help you understand your summary statement, and if they were present for the review, the demeanor of the reviewers in evaluating your idea. Your Program Officer might also be able to enlighten you about comments, both positive and negative, that may have been made during the review. This is a really critical step! NIH strongly encourages dialogue with program staff.
To resubmit or not to resubmit…
If you decide to resubmit, you can choose one of two approaches:
- Revise your submission and request the same study section
- Revise and request a different study section
Either way, you’ll need a one-page introduction addressing review critiques along with proposal revisions. In BBC’s experience, it is usually advisable to request the same study section, since reviewers will look at your application in the context of their prior comments and are more likely to recognize and appreciate that you have addressed their concerns. HOWEVER, you should check out the expertise of the people listed on the roster attached to your summary statement to be sure it is appropriate to your topic and they are knowledgeable about your methods. Your rationale for requesting a different group needs to be clarified in your cover letter so CSR (Center for Scientific Review) understands why a different study section is appropriate. Again, talk to your Program Officer, who will give you an idea if this is the right group or if you should request a different study section. Remember, however, that your request to change study sections may not be honored.
If, after careful deliberation and input from others, you decide to resubmit, your next task is to resolve the issues identified in your summary statement. The NIH’s National Institute of Allergy and Infectious Diseases website offers a good list, which we’ve included below, of common problems cited in summary statements and possible solutions:
Common Fixable Problems
Problem: Poor writing, formatting, or presentation.
Solution: Rewrite; get help with writing, editing, formatting, and presentation.
Problem: Insufficient information, experimental details, or preliminary data
Solution: Assess what’s missing; add it to the Research Plan.
Problem: Significance not convincingly stated
Solution: Beef up that section; show the importance to NIH’s mission, your area of science, and public health. Add market and incidence data that shows how the world will be better off when your product is developed.
Problem: Research not shown to be feasible by the proposed staff
Solution: Recruit collaborators and consultants with the required expertise onto your project or expand your current biosketches.
Problem: Insufficient discussion of obstacles and alternative approaches
Solution: Describe what you’ll do if you get negative results or an approach doesn’t pan out. Perhaps, include decision trees.
The following problems are either not fixable or nearly impossible to correct, so best not to waste time revising such an application.
- Low-impact research topic
- Philosophical issues, e.g., the reviewers do not think the work has significance
- Hypothesis is not sound or not supported by the data
- Work has already been done
- Methods proposed were not suitable for testing the hypothesis
If your comments are in the “hard-to-fix” category, it might be best to revise your topic and create a new proposal or look for funding from another agency.
At BBC, we work with clients at every stage of the process of preparation, submission and post-submission outcomes, whether grant and contract management or assessment and resubmission. We’ll cover in a future blog which other agencies allow resubmissions, and how to approach them to maximize your success.
Jayne Berkaw is Director of Marketing & Outreach for BBCetc