51在线

Research CCHIP #024

CLARIFICATION OR CHANGE IN PROCEDURE (CCHIP)

SBIR and STTR Sponsored Awards

OVERVIEW

Several federal agencies receive congressionally-mandated funding to support research and development activities under the Small Business Innovation Research (鈥淪BIR鈥�) and Small Business Technology Transfer (鈥淪TTR鈥�) programs. The goals of these programs are the stimulation of technological innovation and private sector commercialization of tech- nology developed through federally supported research and development. University of South 51在线 (鈥淯SF鈥�) investigators may be interested in participating in SBIR and STTR funded research. However, such involvement may result in conflicts of interest for USF, the investigators, and the small business without clarification. To facilitate such involve- ment and to ensure timely review and determinations regarding conflicts of interest, USF establishes policies and guidelines for participation in SBIR and STTR programs by USF investigators as outlined in this CCHIP.

DEFINITIONS

Conflict 鈥� A relationship(s) that has/have been determined to be Significant Finan- cial Interests (SFIs) per university policy and/or agency terms and conditions. Fur- ther, for Public Health Service (PHS)-funded projects, a reportable Financial Con- flict of Interest (FCOI) exists when the investigator's Significant Financial Interest(s) could directly and significantly affect the design, conduct, or reporting of the PHS- funded research.

Effort 鈥� The proportion of time spent on a particular activity expressed as a per- centage of total activities.

Financial Conflict of Interest (FCOI) 鈥� A Significant Financial Interest that could di- rectly and significantly affect the design, conduct, or reporting of PHS-funded re- search.

Immediate Family 鈥� A spouse, domestic partner, or dependent children of an inves- tigator.

Lead Principal Investigator 鈥� The primary individual designated to provide the sci- entific and technical direction to a project supported by the funding agreement. 

Equity interest 鈥� All shares, member interests, partnership interests, or any right or obligation which would entitle any person to acquire such interest in an entity to share in equity, profit, earnings, losses, or gains of such entity, including stock, stock options, or other ownership interests--regardless of value.

Phase I 鈥� First phase of the SBIR/STTR that involves feasibility and proof of con- cept. PHS-funded Phase I projects are exempt from determinations regarding FCOIs, but not SFIs.

Phase II 鈥� Second phase of the SBIR/STTR that involves research and research development. PHS-funded Phase II projects that have related SFIs must be as- sessed for a determination regarding FCOIs and any FCOIs must be reported to the sponsor.

Small Business 鈥� A for-profit entity operated in the United States with, along with its affiliates, less than 500 employees.

Small Business Innovation Research (SBIR) 鈥� A congressionally-mandated pro- gram that funds early-stage research and development at small technology com- panies.

Small Business Technology Transfer (STTR) 鈥� A congressionally-mandated pro- gram that funds cooperative research and development projects involving a small business and a research institution.

Subaward Principal Investigator 鈥� The primary individual with the subrecipient or- ganization that provides scientific and technical direction in conjunction with the Lead Principal Investigator.

CLARIFICATION OR CHANGE

Currently, USF has no conflict of interest policy regarding investigator involvement with small businesses receiving funds under the SBIR and STTR programs. It is the purpose of this CCHIP to establish such policy.

PROCEDURES

There are a number of federal requirements for both SBIR and STTR programs that, among other things, restrict the amount of effort USF investigators can conduct as part of the research. A concern of USF is to ensure timely review and determinations regarding potential conflicts of interest arising from USF investigators and their family鈥檚 involvement with existing relationships with these small businesses.

SBIR

Small business receiving funding under the SBIR may, but are not required, to col- laborate with USF. However, during Phase I, the Small Business must conduct two- thirds (2/3) of effort while USF may conduct one-third (1/3). During Phase II, the Small business must conduct at least one-half (1/2) of effort while USF may con- duct up to one-half (1/2). At all times, the Lead Principal Investigator must be pri- marily employed by the Small business (over 50%).

There are a number of situations involving SBIR funding that creates a variety of risk for conflicts. The following situations represent the level of risk and solutions to dealing with such risk

High Risk: USF investigator intends to serve in the role as Lead Principal Investigator by reducing USF full-time equivalency while still maintaining employment at USF.

Solution: USF investigator cannot be employed as a USF employee on the grant and serve as Lead Principal Investigator.

Medium Risk: USF investigator or immediate family has a conflict related to the research, meaning an equity interest in the Small business, investorship of licensed/optioned intellectual property, patented intellectual property, or position on the Small business鈥� Board of Directors.

Solution: During the proposal process, all relationships should be clearly described in the text of the application and elsewhere as needed. To address these conflicts at proposal, USF assesses and may attempt to manage the relationship, up to and includ- ing change in role to co-PI as needed. Generally, certain spon- sors, such as NSF, will not allow the individual to serve as Principal Investigator of the proposed subaward if the person has such a conflict. At award, investigators with SFIs will need to submit COI disclosures so that a COI management plan may be implemented prior to research commencing. For PHS- funded research with related FCOIs, a report must also be submitted to the sponsor prior to research commencing. The COI Program reviews research on a project-specific basis and makes determinations based on the nature of the research and the amount and nature of interest. 

Low Risk: USF investigator or their immediate family has no relationship with Small Business and does not hold any patented and/or licensed/optioned intellectual property related to the research.

Solution: No conflict exists.

STTR

Unlike the SBIR, a Small business receiving funds under the STTR must collabo- rate with USF for a portion of the award. During the entirety of the award, the Small business must conduct at least forty percent (40%) of the research while USF must conduct thirty percent (30%). The Principal Investigator may be employed by USF (over 50% FTE) except with NSF awards, which requires primary employment by Small business. During Phase I, the Principal Investigator must commit a minimum of 10% of effort to the award.

There are a number of situations involving SBIR funding that creates a variety of risk for conflicts. The following situations represent the level of risk and solutions to dealing with such risk:

High Risk: USF investigator intends to serve in the role as Small business Principal Investigator.

Solution: USF investigator employed by the Small business may serve in the role as Principal Investigator under certain circum- stances: (1) he/she cannot be providing signing authority or administrative oversight/activities for the Small business with Sponsor; (2) Principal Investigator role must be explicitly de- tailed in the USF subaward scope of work; (3) One percent (1%) of ten percent (10%) of effort (or minimum allowed by sponsor) should be clearly delineated as Principal Investigator role for scientific and technical components.

Medium Risk: USF investigator or immediate family has a conflict related to the research, meaning an equity interest in the Small business, investorship of licensed/optioned intellectual property, patented intellectual property, or position on the Small business鈥� Board of Directors.

Solution: During the proposal process, all relationships should be clearly described in the text of the application and elsewhere as needed. To address these conflicts at proposal, USF assesses and may attempt to manage the relationship, up to and includ- ing change in role to co-PI as needed. Generally, certain sponsors, such as NSF, will not allow the individual to serve as the Principal Investigator of the proposed subaward if the per- son has such a conflict. At award, investigators with SFIs will need to submit COI disclosures so that a COI management plan may be implemented prior to research commencing. For PHS-funded research with related FCOIs, a report must also be submitted to the sponsor prior to research commencing. The COI Program reviews research on a project-specific basis and makes determinations based on the nature of the research and the amount and nature of interest.

Low Risk: USF investigator or their immediate family has no relationship with Small Business and does not hold any patented and/or licensed/op- tioned intellectual property related to the research.

Solution: No conflict exists.

CONTACT

Please address your questions regarding this CCHIP to your assigned Sponsored Re- search Administrator.

RESOURCES

USF Facilitates and Administrative Cost webpage

EFFECTIVE DATE

This CCHIP is effective as of the date of revision and rescinds all previous versions pertaining to SBIR and STTR Sponsored Awards.

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ISSUED: March 11, 2021
LAST REVISION: March 11, 2021