FCOI Committee review of SBIR/STTR funding

As of November 2023, the Financial Conflict of Interest Committee has implemented a new Standard Operating Procedure (SOP) for its review of SBIR/STTR awards where subaward funds are proposed to flow from a company owned by a Columbia researcher to his/her Columbia lab. This SOP establishes guidelines for managing conflicts of interest inherent in such funding arrangements.

This SOP applies only to Phase 1 SBIR/STTR awards that do not involve human subjects.

The FCOI Committee is unlikely to find that conflicts can be managed for a Phase 1 SBIR/STTR award involving human subjects, or for Phase 2 SBIR/STTR awards of any kind.

  1. Where a Columbia researcher, including the PI or any other investigator, holds equity or any other significant financial interest in a small company that seeks SBIR or STTR funding, it is not ordinarily allowable for the company to support the researcher’s Columbia research, including through a subaward from the company to the investigator’s laboratory.
  1. In the case of a Phase 1 SBIR/STTR award, the Committee may find that there are countervailing circumstances that warrant allowing the investigator to conduct such research funded by a subaward from the investigator’s company. In that case, if certain conditions are met, the FCOI can be managed to protect the objectivity of the research and address other risks that may be identified.
  1. In implementing this SOP, the FCOI Committee recognizes that Phase I SBIR/STTR funding supports early-stage “proof of concept” research and commercialization that is limited in duration and dollar amount, which helps mitigate the potential conflict of interest risk. The potential benefits of the researcher’s involvement in these projects to support commercialization of technology may outweigh the risks posed by actual or apparent conflicts of interest, provided that such conflicts can be managed in accordance with the SOP.
  1. This SOP does not apply to human subjects research. Absent extraordinary circumstances, the FCOI Committee is unlikely to find that conflicts for Phase 2 SBIR/STTR awards can be managed. 
  1. A management plan for Phase 1 SBIR/STTR subaward would typically require the following, at a minimum:
    • The Columbia faculty member’s participation in the SBIR/STTR award is limited to the Columbia subaward, and does not include serving as an investigator on the prime award to the company;
    • The Columbia faculty member does not hire or assign a Columbia student they mentor to conduct work on behalf of the small business without approval by the FCOI Committee;
    • The Columbia faculty member does not apply Columbia’s resources, e.g., laboratory facilities or staff, or any federal funds to benefit the small business’s interests in a manner inconsistent with Columbia’s non-profit status;
    • The Columbia faculty member alerts the FCOI Committee if the subaward is to be modified;
    • The Columbia faculty member contacts the FCOI Committee if the sponsoring agency requests additional information about the faculty member’s financial interest in the small business;
    • All funding agency requirements are met; and
    • The Columbia faculty member must disclose their financial interest in the company in all publications and public presentations of the research, and to all participating investigators and appropriate members of the laboratory or research group, students, and trainees.

Depending on the nature of the research, the Committee may add other requirements to the management plan as appropriate, such as independent review of progress reports or publications or other management strategies.

In addition, the Committee recommends that any management plan for a Phase 1 project should include plans to transition the research to Phase 2. Such plans could include transferring the work to a non-conflicted PI at Columbia or another institution.

Finally, in the event that the University has an ownership interest in the small business, the University’s Institutional Conflict of Interest Committee will also need to review the matter. It will take into account the management plan addressing the individual researcher’s conflict, but may add other requirements to address any institutional conflict.  The Office of Research Compliance and Training works to coordinate these reviews in as efficient a manner as possible.

Outside Resources

NIH SBIR/STTR information: https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr

NSF SBIR/STTR information: https://seedfund.nsf.gov/