Track 1 Session Descriptions
Research Involving Human Subjects (Ann Hardy)
Need to know how to address research involving human subjects in your grant application? This session provides valuable information on this and other topics, including an overview of HHS regulations, NIH policies and guidance for research involving human subjects.
Are you considering using live vertebrate animals in your research? Are you aware that the policies and regulations regarding research on animals are different than those involving humans? This session provides information on: (1) the requirements for using animals; (2) appropriate completion of the vertebrate animal section of the grant application and peer review considerations; (3) the functions of an Institutional Animal Care and Use committee; (4) details on the various assurance documents including which type is required if your institution does not have its own animal facility; and (5) the consequences of what happens when animal activities become noncompliant.
Nearly one-third of all small business applicants submit applications with errors that require correction. Many applicants don’t understand the process well enough to even know there is a problem until it is too late. In this session, we’ll explore the process applicants must follow to prepare, submit, track and verify their electronic submission. We will provide valuable tips and resources to help small businesses achieve error-free applications and a successful submission.
Once you know you received a fundable score, we know that you want to get the award as fast as possible. This presentation goes over Just-In-Time (JIT) materials that NIH needs prior to award. Typically, these include: Other Support, IRB/IACUC Approvals, SBIR or STTR Verification Statement Forms and other information requested by the awarding IC. Knowing what to expect can help you prepare. Good preparation will help you get your award as soon as possible. In addition, the presenter will explain the usual SBIR/STTR JIT requirements.
You’ve got a great idea – it will change the world! All you need to do is write the proposal to get your project launched with SBIR/STTR funding. But writing the proposal is pretty difficult. Or is it? Join us in this Phase I Proposal Development session where we will develop framework to help you prove the following hypothesis: “A clear understanding of the review criteria combined with comprehensive strategic planning and sufficient time will make proposal development the easy part.”
You thought being selected for an award was difficult, but getting to the marketplace can be even more challenging. Biomedical research can take millions of dollars and 10+ years before a product reaches consumer hands. So how are you planning to get there? NIH offers several assistance programs to help SBIR/STTR awardees strategize how to commercialize their SBIR/STTR developed products. Join this interactive session with several executives who have not only successfully competed for SBIR/STTR dollars and grown their small businesses from the ground up, but also leveraged NIH’s technical assistance programs to help them differentiate themselves from the competition and penetrate into crowded markets. Don’t miss this opportunity to ask all your burning questions and find out how to take advantage of these resources and know-how!
You’ve made it through the first hurdle – getting your Phase I funded. You’ve achieved your aims. You’ve demonstrated feasibility. You’re ready to write and submit your Phase II proposal. Or are you? In this session, we’ll explore key considerations for the Phase II proposal with specific emphasis on commercialization. We’ll provide framework for a strong commercialization plan, discuss key activities that you can initiate while still working on your Phase I project and review the overall attributes of a strong and well-crafted proposal.
Resolving SBIR/STTR Allegations of Waste, Fraud and Abuse to Promote Program Integrity (Maritza Zeiberg)
Learn about the roles and responsibilities of the Division of Program Integrity (DPI) and find out how it is an important component of NIH efforts to oversee, detect and prevent fraud, waste and abuse. Know what to do if your company is involved in a DPI review. DPI, in the Office of Management Assessment, conducts reviews of non-criminal allegations of misuse of NIH grant and contract funds, NIH grantee and contractor conflict of interest, violations of grant or contract laws, regulations or policies and issues referred to NIH by HHS Office of Inspector General (OIG) when prosecution or civil action has been declined or when OIG plans no further investigation. DPI is also responsible for reporting to OIG allegations that are or appear to be violations of criminal law.
Diversity, Disability and Re-entry Supplements (Scott Somers, Jonathan Gindes and Maureen Mulvihill)
NIH staff will describe funding mechanisms used to award Diversity, Disability and Re-entry Supplements. This session will have two small business concerns and individuals who have benefited from these awards discuss their successes and secrets to the process.
Since federal agencies provide funding to develop innovative research (a.k.a. investigator-initiated research), the majority of NIH SBIR awards are grants. But did you know that NIH and other federal agencies also offer contract opportunities through the SBIR mechanism? The NIH SBIR contract solicitation is issued annually in the summer with proposals due in early November and includes topics identified by program staff aimed at soliciting research in targeted scientific/technical area. In this session, you will learn:a)what differentiates SBIR contracts from SBIR/STTR grants; b)how to hear about and submit proposals in response to SBIR contract solicitations; and c) some of the unique requirements of contracts vs. grants, such as reporting and OMB requirements.
The intent of this session will be to try to answer any additional questions that might have come up from the conference. Any and all topics from our earlier sessions are welcome. If the guest presenters cannot answer your question on the spot, we will direct you to appropriate resources. We will also field questions concerning what worked at the conference and areas where improvement is needed.