Duke University SBIR/STTR Implementation Procedure
May 30, 2019
Purpose
To establish a procedure for Duke University faculty and staff participation in the Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) programs.
This Duke University SBIR/STTR Implementation Procedure is to be applied in concert with the University’s other policies and procedures, including but not limited to Financial Conflicts of Interest in Research Policy, Institutional Conflicts of Interest in Research Policy, and other policies related to sponsored research.
Program Overview
The federally-funded SBIR and STTR programs stimulate innovations that encourage domestic small business concerns (SBC) to engage in research and development that has the potential for commercialization. SBIRs and STTRs are awarded directly to an SBC, which may issue a subcontract to Duke.
Currently, eleven separate agencies participate in the SBIR program, and five in the STTR program, and the standards can differ from program to program. Generally, the key differences between the two programs are as follows:
|
ISSUE |
SBIR |
STTR |
|---|---|---|
|
LEAD PI |
Lead PI must be primarily employed by the SBC (e.g. 51% of full-time effort) at the time of award and for the duration of the award. This means Duke faculty are not eligible to be lead PI on a SBIR |
Primary employment of lead PI is not stipulated (can be a Duke employee) Duke faculty or employee must have at least 10% effort on the award, which must be limited to either Duke or the SBC (NOT BOTH) |
|
TERM |
Phase I: up to 6 months Phase II: up to 2 years |
Phase I: up to 1 year Phase II: up to 2 years |
|
IS COLLABORATION REQUIRED? |
Allowed, but not required |
Requires collaboration with a non-profit research institution |
|
LIMITS ON SUBCONTRACTING DISTRIBUTION |
Phase I - a maximum of 33% of the work may be subcontracted to third party Phase II, a maximum of 50% of the work may be subcontracted to a third party |
Phase I and Phase II— a minimum of 30% of the work (maximum of 60%) must be subcontracted to a non-profit research institution (i.e., must be a formal collaboration) |
*A Duke faculty member may participate on one side of the project or the other, but cannot participate on both the company and the Duke side (even if the effort is unpaid on one side). Please contact ORA if you have any questions about this requirement.
Procedures
Conflict of Interest
Personal COI. If anyone on the proposal for Duke (faculty, student, fellow, staff, contractor, consultant, etc.) has a financial interest in the SBC (e.g., equity, options, compensation, rights to IP that the SBC acquired, etc.), the Duke PI and/or the potentially conflicted individual(s) must consult with the Duke Office of Scientific Integrity COI (DOSI-COI) to determine if any perceived, potential, or actual COI exists
Institutional COI. The Duke PI and/or the potentially conflicted individual(s) also must consult DOSI-COI if Duke has its own financial interest in the SBC (e.g., equity, options, rights to royalties or other payments through a license)
Pre-Award Review
Review of SBC’s Application. The Office of Research Support (ORS) or the School of Medicine Research Administration (SOM-RA) will request a copy of the SBC’s proposal prior to the SBC submitting it to the agency. If a copy is not available at that time, the pre-award office will require a copy of the SBC’s full proposal prior to finalizing any contract with the SBC
Proposal Cover Letter. The pre-award central office will prepare a proposal cover letter detailing Duke’s general and SBIR/STTR specific standards, which will be submitted to the SBC with Duke’s proposal
Unit Review. Proposals to conduct research at Duke for SBIR/STTR funding should be reviewed by the Department Chair or Institute/Center Director (or designee, to include Vice Chair or Business Manager) to ensure the proposal is in accord with Duke’s policies and procedures for sponsored research:
- Uses Duke research facilities (labs, IACUC, IRB, etc.) only for Duke’s portion of the project
- Has approval for use of Duke research facilities (labs, IACUC, IRB, etc.) and any use of Duke facilities is solely for Duke’s portion of the project
- Reflects full cost recovery of direct and indirect costs
Intellectual Property. A request for proposals for a SBIR/STTR sometimes requires that the SBC and Duke agree to terms on ownership and licensing of intellectual property before the agency issues its award to the SBC. If so, contact the appropriate pre-award office as soon as possible to begin that process, as the negotiation may take time and requires input from the Office of Licensing & Ventures
Private Benefit. The pre-award office will review to ensure that the SBC does not use Duke’s resources to benefit the SBC’s interest at the expense of Duke’s non-profit status. The following are examples of prohibited activities:
- Using Duke’s personnel (e.g., departmental research administration staff) to prepare or submit the SBC’s proposal, to administer the award
- Using Duke’s resources (e.g., personnel, equipment, space, etc.) to operate its business or to complete any portion of the SBC’s work
Final Contract. Once the SBC’s proposal is awarded, the SBC and Duke must finalize and execute a subcontract or other agreement