Stacy Chin breaks down what NIH SBIR Phase I applications need: a six-page research strategy at the center, plus specific aims, methods, data analysis plans, and anticipated deliverables. Every claim must cite peer-reviewed literature. The full package includes budget, biosketches, facilities, and letters of support.
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In your Phase I application, you'll want to inform the reviewers what experiments you plan to do, a justification as to why you're doing those experiments, how you plan to perform these studies, how are you collecting and then analyzing that data, what are the anticipated deliverables, and what problems may you encounter along the way and solutions to solve them. And all of your technical arguments and your hypothesis should be supported by existing peer-reviewed research to justify the need for your proposed research efforts. Your NIH Phase I SBIR or STTR application will require you to prepare a 6-page research strategy. And this is the main technical document that will undergo the most scrutiny from the reviewers. In addition to the research strategy, there are lots of other supporting documents, such as the abstract, the project narrative, the budget, budget justification, bio sketches, facilities and resources, specific aims, reference lists, and letters of support.