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Guidance and Research Management Plan for SBIR/STTR Work

Participating in Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grants

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are Congressionally-mandated set-aside programs for domestic small business concerns to engage in Research/Research and Development (R/R&D) which has the potential for commercialization.

The SBIR Program includes the following objectives: to use small businesses to stimulate technological innovation, to strengthen the role of small business in meeting Federal Research and Development needs, to increase private sector commercialization of innovations developed through Federal SBIR R&D, to increase small business participation in Federal R/R&D, and to foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program.

The STTR and SBIR programs are similar in that both programs seek to increase the participation of small businesses in Federal R&D and to increase private sector commercialization of technology developed through Federal R&D. The unique feature of the STTR program is the requirement for the small business concern applicant organization to formally collaborate with a research institution in Phase I and Phase II.

Principal Investigators

Under the SBIR program, for both Phase I and Phase II studies, the primary employment of the PD/PI must be with the small business concern at the time of award1 and during the conduct of the proposed project. Primary employment means that more than one half of the PD/PI's time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization2, including Caltech. If there are multiple PD/PI's the first PI listed on the SBIR must meet these criteria.

For STTRs, the first PD/PI listed on an STTR must be affiliated with the applicant small business concern and will serve as the Contact PD/PI. For the STTR, the Contact PD/PI may be from either the small business concern or the single partnering research institution. The Contact PD/PI must have a formal appointment with or commitment to the small business concern, which must be in the form of an official relationship3 between the parties, but need not include a salary or other form of remuneration.

The PD/PI must commit a minimum of 10% (1.2 calendar months) effort to the project. The PD/PI's official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project.

SBIR STTR Research Management Plan

While there are standard federal-wide requirements for the SBIR and STTR programs, each agency issues its own implementation guidelines and separate calls for proposals. Under the NIH guidelines for Principal Investigators, it is possible that a Caltech faculty member could receive SBIR or STTR funding as (1) an SBIR subawardee acting as a collaborating (not primary) PI on an SBIR, (2) as an STTR subawardee acting as the primary or collaborating PI on an STTR, or (3) through a facilities use or technical services agreement4 in the faculty member's lab.

Caltech faculty are entrepreneurial and there is a likelihood that a Caltech faculty member receiving SBIR or STTR funding may have some relationship with the small business concern/grantee. To ensure research integrity, to avoid conflicts of interest, and to protect Caltech, its faculty, staff and students, it is recommended that each faculty member receiving SBIR or STTR funding as an awardee develop and implement a Research Management Plan. The following is a list of considerations to take into account when developing a Research Management Plan.

The questions are available in a WORD DOCUMENT which can be used as a template for developing a plan.

STTR/SBIR Research Management Plan Considerations:

  1. The Small Business Concern: Who is the PI for the small business concern? Is this PI also the Caltech PI?

    Note: A Caltech faculty member may not serve as PI on an SBIR project. However, under certain circumstances, it is possible for a Caltech faculty member, not employed by the small business, to serve as PI on the overall project.
  2. The Principal Investigator: Does the Caltech PI meet the SBIR or STTR requirements for PI (see above)?
  3. The Research: Is the Caltech PI performing research (i.e. contributing intellectually to the work being done) or merely providing data/results or lab facility use to the small business concern?

    If the Caltech PI is not contributing intellectually (i.e. interpreting data and/or providing reports), then it is likely that Caltech is providing use of facilities or technical services to the small business concern. If this is the case, a facilities use or technical services agreement should be put in place. Is there a clear distinction between the work done by the small business and the work performed at Caltech? Is the work being done at Caltech in line with Caltech's educational purpose?
  4. Ownership Interests: Does the Caltech PI (or his/her immediate family) have an ownership interest in the small business concern? If so, what is the extent of the interest?

    Disclosure to the Division Chair is required if the faculty member is to receive sponsored support for research from a business for which the faculty member is a consultant, or in which the faculty member has a significant financial interest (Institute Policy on Conflicts of Interest).
  5. Research Staff/Students:

    a. Are any of the small business concern's management also Caltech employees or students?

    The STTR or SBIR funds should not be used to fund these persons' research activity at Caltech.

    b. Student Participation: Will students or post-docs participate in this research?

    If the faculty member has an ownership interest in the small business concern, any involvement of students or post-docs in this research should be approved in advance by the Division Chair and the student must sign a written disclosure to signify understanding of the issues involved (Institute Policy on Conflicts of Interest).
  6. Facilities: What Caltech facilities will be used?

    The Caltech facilities should not function as the small business concern's facilities. That is, the small business concern should have its own research and development space.

    Are there any encumbrances or obligations imposed on use of the Caltech facilities that could impact this research?
  7. Other Sponsorship: Is there any overlap between this research and other sponsored research? What is the plan for allocation of resources among grants/contracts? How will the PI ensure that the design and conduct of the research is handled in a fair and objective way relative to each of the different sponsors and the sponsors' expectations? How and when will research results be reported to the small business concern and the other sponsors?
  8. Intellectual Property: What is the disposition of intellectual property resulting from this research? What about Caltech background intellectual property? Will the sponsor provide proprietary information/intellectual property?5 If there are multiple sponsors, how will the intellectual property issues be addressed?

    Several agencies require that there be a written agreement between the small business concern and Caltech allocating intellectual property6 prior to funding. Caltech's Office of Technology Transfer can provide a Disposition of Patent Rights Agreement when needed.
  9. Publication: Is the sponsor imposing delays or restricting publication in any way other than deferring publication for a limited period of time in order to file for patent protection? Does the sponsor ask for more than an opportunity to review and comment on publications?5

    No outside organization has a right to delay submission or to refuse publication of research papers. Any such deferral will require concurrence from the Principal Investigator and the Vice Provost (Faculty Handbook).

Charging, Time and Effort: Are reporting requirements being met?

There are federal regulations for time commitments and effort expenditures. For example, STTRs require PIs dedicate a minimum of 10% effort or 1.2 calendar months. For SBIRs, a minimum of 67% or 50% of the effort must be performed at the small business concern for Phases I or II, respectively. For STTRs, a minimum of 40% of the work must be performed at the small business concern and a minimum 30% of the work at the research institution in both Phase I and Phase II.

[1] If the application has the likelihood of funding, and if the PD/PI is employed by an organization other than the applicant organization, the PD/PI must provide letters from each such employer stating that the PD/PI will become less than half time (and remain so) for the duration of the funded SBIR project.

[2] Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.

[3] Documentation (e.g., consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.

[4] The process for establishing Facility Use or Technical Services Agreements addresses the research management concerns, so is not covered in this discussion.

[5] Restriction of publication or receipt of third party proprietary information may raise export control issues. Please consult with the Office of Export Control.

[6] Some agencies provide model agreements: