BHGC Step-By-Step: Phase I Proposal Preparation
Your team has already discussed planning and evaluating your project and your team is ready to move forward with your grant application. Last-minute applications are rarely strong applications. This post describes the proposal preparation stage that Blue Haven Grant Consultants uses to develop your grant application and keep your project moving toward a timely and strong grant application to the National Institutes of Health’s SBIR/STTR program.
Significance-Innovation Analysis
A key aspect of our approach, and a distinct advantage of being a BHGC client, is our proprietary Significance-Innovation Analysis. Significance and innovation are critical scored criteria for the SBIR/STTR programs. These criteria appear deceptively straightforward. Using our unique process, we help you thoroughly review both sections, aligning them to effectively showcase your projects’ use of emerging research and potential commercial impact. This strengthens the narrative of your project, enhances the application’s coherence and compelling nature, and improves your scoring potential. Consider this a deep exploration of your core research questions and insights, refined into a concise, persuasive, and potent set of questions with clear, logical research objectives and specific aims.
Finalize Specific Aims
Flowing from the Significance-Innovation Analysis, we collaborate with your team to articulate potent and concrete research objectives. We focus on enhancing the clarity, measurability, independence, and team alignment of each specific aim. This will guide the remainder of our grant writing, ensuring NIH reviewers understand that your project is designed for success.
Research Plan Section Writing
The natural outcome of our Significance-Innovation Analysis and generation of strong specific aims is a compelling, concise, and clear research plan and narrative. This forms the core of your application and conveys crucial information to NIH reviewers. By focusing on scored criteria, it demonstrates to the review team that a novel and innovative product is being developed.
Key Personnel and Collaborator Identification
Our preparation process assists in identifying key team members and collaborators, emphasizing their importance to NIH reviewers, and demonstrating your capacity and competency to execute your ambitious research plan. This involves creating and refining team biosketches, ensuring a strong team/collaborator fit, and highlighting their significance within the project narrative.
Budget analysis
Your budget outlines how you will allocate funds to advance your innovation toward development and market, which is a critical component of your application. Our team will review your budget to ensure its narrative aligns seamlessly with that of your research summaries and plan. Consistent alignment is paramount.
Write Ancillary Documents
SBIR/STTR grant applications require significant supporting documentation. As part of the proposal preparation process, the BHGC team will help you create and secure the necessary ancillary documents needed to support your compelling project narrative and NIH grant application.
Facilities and Other Resources
This section is your opportunity to showcase the robustness of your operational environment. Describe in detail the laboratory, office, clinical, animal, and computer facilities at your disposal. If you're leveraging resources through collaborations, clearly outline those arrangements. This section should convince reviewers that you have the ideal setting for project success.
Equipment
This provides a comprehensive inventory of major equipment. Detail what's already on hand and any additional equipment you plan to acquire with grant funds to help further your research objectives. The goal is to demonstrate that you are well-equipped to execute your work effectively.
Letters of Support
These documents carry substantial weight, as they validate external commitment to your project. Secure letters from key collaborators actively involved in the research, consultants providing specialized expertise, potential customers or end-users who see your technology’s value, and even investors who might be interested in future development. Each letter should clearly define the supporter's role, their specific contributions, and their enthusiasm for the project and its potential impact.
Data Management and Sharing Plan
In alignment with NIH's emphasis on transparency, you must outline a thorough data management and sharing plan. Detail the types of data you will generate, how it will be stored and preserved, and how access will be managed. Explain your plans for making data publicly available, adhering to NIH guidelines and FOA requirements. If data sharing is restricted or not applicable, provide a solid justification. This plan should demonstrate your commitment to responsible data practices and advancing scientific knowledge.
Vertebrate Animals Section
If your research involves live vertebrate animals, provide exhaustive details addressing the following:
Description of Procedures: Clearly and concisely describe all procedures involving vertebrate animals.
Justification: Provide a robust rationale for why vertebrate animals are necessary to achieve your research objectives.
Species, Strains, Numbers, and Source: Specify the species, strains, ages, sex, and total number of animals you intend to use, and clearly state their source.
Veterinary Care: Detail the veterinary care protocols that will be in place.
Pain and Distress: Describe in detail the measures you will take to minimize pain and distress to the animals.
Your Institutional Animal Care and Use Committee (IACUC) approval is generally mandatory before an award can be granted.
Select Agent Research Section
If your project involves select agents (biological agents and toxins that pose a severe threat to public health), detailed information aligned with federal regulations is essential. Provide a comprehensive description of the select agents, the biosafety precautions and containment procedures, and the expertise of the personnel handling these agents. Institutional Biosafety Committee (IBC) approval is required.
Multiple PD/PI Leadership Plan
For projects with multiple Principal Investigators (PD/PIs), you must present a clear leadership plan. Detail the roles and responsibilities of each PD/PI and how they will operate as a unified team. This plan should outline communication strategies, decision-making processes, and the overall management structure, ensuring a cohesive and effective leadership approach.
Resource Sharing Plan(s)
Some Funding Opportunity Announcements (FOAs) will require specific plans for sharing research resources, such as model organisms (e.g., mice, cell lines) or software tools. Describe how you will make these resources accessible to the broader scientific community.
Submission!
Through our collaborative process, you've reached the submission stage! There's no need to worry about navigating cumbersome NIH forms and applications. We are experts at navigating the systems and logins necessary to officially submit your application. Allow us to handle those small details and processes while you and your team relax after this intensive process.
In the next installment of our Step-by-Step series, we'll discuss the review process for when your team receives NIH feedback.
And if you’re ready to benefit from the BHGC Advantage, don’t forget to schedule a free consultation through our website!