SBIR/STTR

This is another potential problem in SBIR/STTRs granted to start-ups. In many cases UM may have relationships with the SBCs; e.g., licensed intellectual property to the SBC in exchange for equity. It could be perceived that UM would be less assertive in its oversight of the research if the institution stood to profit financially from the research.

UM nevertheless expects that faculty will want to be involved in SBCs and in the SBIR/STTR proposal process, and UM knows that these activities can be beneficial to the faculty member’s career as well as to the institution and to the community at large. However, a few compliance steps must be undertaken.

UM Faculty must notify UM when the SBC in which they have an interest or with which they have a relationship applies for SBIR/STTR funding and the faculty member (or another UM employee) expects to work on the subaward to UM from the SBC. This notification can be done by directly contacting Research Administration. 

In certain circumstances, the Office of Vice Provost for Research and Scholarship, Disclosures & Scholarly Activities Management (DSAM) DSAM and/or the Conflict of Interest Committee may be involved in review of the relationship. In addition to Intellectual Property licenses, contracts between UM and the SBC should address contracting costs and anticipated research utilization (if any).

The DSAM and the Conflict of Interest Committee are responsible for review and management of COIs between UM employees and the SBC as they relate to sponsored research. Generally, these entities will be alerted in the following situations to allow for their review and determination:

1. The UM faculty member seeks to be the PI for the SBC (or has a supervisory relationship with the SBC PI) or wishes to work on the subaward from the SBC to UM; and
2. The UM faculty member seeks to be PI on a subaward from the SBC (or has a supervisory relationship with the SBC PI) and has a significant ownership interest in, or ≥$10,000/year financial relationship with, the SBC. 1 

The UM COI Committee has approved a procedure for Phase I SBIR/STTR projects through which a UM faculty member with a significant financial interest in a SBC can serve as lead PI on the subaward between the SBC and UM, as long as the following conditions are met:

1. The sponsoring agency does not have a rule stating that the faculty member’s interest in the SBC must be considered a significant financial interest for determining a COI;
2. The UM faculty member does not serve as the lead PI, investigator or consultant for the SBC on the award from the sponsor;
3. The UM faculty member does not hire a UM student she/he mentors to conduct work on the subaward without contacting the Office of Disclosures & Relationship Management to discuss appropriate COI management;
4. The UM faculty member does not apply UM’s resources or any federal funds to benefit the SBC’s interests in a manner inconsistent with UM’s non-profit status;
5. The UM faculty member informs the Research Administration and provides copies of each invoice and progress report submitted to the SBC, which can be provided at the halfway point of the subaward and upon submitting a final report;
6. The UM faculty member alerts the COI Committee’s designated representative if the subaward is modified and a human subject protocol is submitted to the Institutional Review Board for approval; and
7. The UM faculty member contacts the COI Committee’s designated representative if the sponsoring agency requests additional information about the faculty member’s financial interest in the SBC.

In order to protect non-licensed UM IP and facilitate submission, all UM PIs will be required to disclose whether or not non-published data, know-how, software or any other potential UM IP (including IP that is not patentable) is being incorporated into the grant submission. The SBC must indicate willingness to negotiate an option or license agreement to UM-IP in the event that the grant is awarded. An option agreement will enable development of existing UM innovations exclusively by the SBC. The level of funding to the SBC is minimal in comparison to the UM work done/resources utilized to enable grant submission. Unless the IP is licensed upon award of the grant, any results developed through an option agreement will belong to UM. Please contact the Research Administration at mra@miami.edu to request additional information about pursuing this option. For additional information, please visit: https://seed.nih.gov/faqs, https://seedfund.nsf.gov/about/, or https://www.dodsbirsttr.mil/submissions/login.

No. Although many SBIR/STTR applications include subawards to universities, under federal regulations, only small business concerns (SBCs) may apply for SBIR and STTR funding. STTR guidelines require the SBC to formally collaborate with a University or non-profit research institution. For SBIRs, this collaboration is optional.

Typically, this is done by conducting research at UM under a subaward from a small business that has received an SBIR or STTR award. ORA staff can assist UM PIs in completing and submitting paperwork needed to initiate the subaward application and contracting process.

Plans for proposed research to be conducted at UM under an SBIR or STTR subaward from a SBC must be reviewed by appropriate department chair and academic dean (Gables and RSMAS) before subaward proposal materials are forwarded to ORA. This review is intended to ensure that the proposed work (a) has scientific merit, (b) constitutes a good use of UM research facilities, (c) will not compromise the PI’s academic responsibilities, (d) is for a unique and specific scope of work distinct from research funded by other outside entities, (e) is for work that does not overlap with the investigator’s other research responsibilities, and (f) reflects full cost recovery (direct and indirect), including the PI’s time, in the project budget.

The UM Faculty Manual addresses outside professional activities specific to faculty working with outside companies as consultants. From a COI and conflict of commitment perspective, it is best for UM personnel to act either as a consultant to the SBC on grant-related activities, or as a researcher on a subaward to UM, but not both. The nature of the work performed defines whether someone can act as a consultant or as a researcher on a subaward, as defined in the Uniform Guidance.

Yes, but there are some key points to keep in mind. Faculty may not hold a full-time appointment at UM and concurrently serve as the Principal Investigator (PI) of an SBIR or STTR grant for a company. In general, the PI for the SBC should not be a UM employee. The PI for the company and the PI for the UM subaward must be separate individuals. See additional discussion below. Work performed by the SBC cannot occur in UM’s facilities.

Yes. Faculty may engage in these types of activities, subject to the time limits and reporting requirements of the Faculty Manual, and the outcome of review by the Conflict of Interest Review Committee (Applicable to those cases in which the investigator has a financial interest in the company that has applied for and received the grant).

In general, no. Under federal SBIR guidelines, the small business applicant must be the PI’s primary employer by the time an award is made and must remain the PI’s primary employer for the duration of the project period.

Although STTR program guidelines permit University employees to serve as the small business applicant’s PI, submission of an application for research support through any organization other than UM requires an exception to the UM policy.

Typically, exceptions have been made when the faculty member agrees to reduce his/her employment at UM or take a temporary leave (part time or full time) 3 from UM to conduct research as the SBC PI.

Please note that the conduct of research is generally not considered the kind of outside professional activity allowed under the UM Faculty Manual. These requests for exceptions should be directed to the Vice Provost for Research.

In general, no. SBIR and STTR funding mechanisms involve a primary grant to the small business concern and a subaward to the University. Thus, there are two PIs: one is PI for the SBC; and one is PI for UM. Typically, the same individual may not serve as both. For example, if you will serve as the SBC PI, then you may serve as a co-investigator on the UM subaward, but you may not serve as the PI on the UM subaward.

If you will be an investigator on both the primary award to the small business concern and the University subaward, then you must disclose and manage the COI. The COI Committee advises that the tasks conducted at the SBC and at UM should be clearly distinguishable from each other. Any UM employees compensated through the subaward to UM may not receive compensation for the same task from the SBC. The COI must be managed prior to the University’s execution of the subaward.

No.

Per UM policies and principles, including Personnel Policies for Staff Members/Conflict of Interest, nonfaculty employees (such as staff and appointees in the research series) are not permitted to engage in activities that create COIs between their UM responsibilities and other interests or obligations. Additionally, outside employment should not interfere with the performance of employees’ UM duties.

UM employees must not use UM resources (i.e., employee time or effort, or resources, including computers or equipment) to write an STTR or SBIR application or perform any work on behalf of an SBC. The University policies and principles prohibit the use of University resources without appropriate remuneration and agreement. The writing of an SBIR or STTR grant application and any tasks associated with administering the SBIR/STTR award and administering the subaward on behalf of the SBC must be conducted using the SBC’s resources, personnel, time and effort.

The SBC must contact UM’s Office of Technology Transfer before submitting its proposal to discuss the availability of the intellectual property and whether an option or license is needed. Doing so may prevent potential claims of intellectual property infringement resulting from the SBC’s use of University-owned intellectual property under the SBIR-STTR award.

Probably. However, these situations are subject to review by the faculty Conflict of Interest Review Committee before the University can accept the research support. If the Conflict of Interest Review Committee determines that the situation creates a COI, it will try to find ways of managing the COI. The 4 Vice Provost for Research and the Conflict of Interest Review Committee Chair are available to confer about specific situations prior to formal committee review.