This section identifies agency-specific conflict of interest reporting requirements and related topics.
The federal regulations have been adopted by other agencies (link here)
ADDITIONAL REQUIREMENTS OR EXCEPTIONS
The California Institute for Regenerative Medicine (CIRM) is a government sponsor. Accordingly, Form 700U does not need to be completed for this agency.
The Fair Political Practices Commission is the state agency responsible for implementation and enforcement of all 700U's, consult the List of Non-Governmental Entities Exempt From Disclosure Requirement to determine whether a disclosure is required for the sponsoring entity.
When a research gift is given to the University of California or to the UCSB Foundation from a non-governmental entity for;
- a specific research project or
- for the use of a specific faculty member,
then the faculty member (usually the principal investigator) must complete a Form 700U through ORCOI (https://ucsb.coi-smart.com).
When UCSB is the recipient of a subcontract, the principal investigator at UCSB must complete "Statement of Economic Interests for Principal Investigators" (FPPC Form 700-U), unless an exception applies.
The Form 700-U does not need to be completed if the subcontract: is from a non-governmental entity that is on the “List of Non-Governmental Entities Exempt From Disclosure Requirement"; is from a non-profit, tax-exempt, educational institution; or is from a governmental agency.
Examples of non-governmental entities are a private company, a non-profit entity, and a private university.
Where UCSB receives the subcontract from a sponsoring entity that receives its funding under a prime funding award from any federal agency, or agency that has adopted the federal regulations, then the UCSB PI must complete the respective electronic disclosures (unless exceptions for submission of Form 700-U apply), and each researcher who has responsibility for the design, conduct, and reporting of the study must complete a disclosure electronically.
Here are four hypothetical examples of which forms to complete under various subcontracts:
- UCSB receives a subcontract from Genentech. Genentech receives its funding from NIH. UCSB must collect both the state form (Form 700-U) from the PI at UCSB , and the disclosures from the PI and all UCSB researchers who have potential conflicts. Genentech is a non-governmental entity and is not exempt.
- UCSB receives a subcontract from The Robert Wood Johnson Foundation (the “RWJ Foundation”). The RWJ Foundation receives its funding from NIH. UCSB must review disclosures of UCSB key personnel. The RWJ Foundation is on the State of California exempt list, and accordingly, the state form does not need to be collected.
- UCSB receives a subcontract from The Parkinson Disease Foundation (“PDF”). PDF receives its funding from the NIH. PDF is a non-profit entity, and it is not on the state exempt list. UCSB must collect both the state 700-U form from the Principal Investigator and the federal disclosures in connection with this subcontract.
- UCSB receives a subcontract from The Parkinson Disease Foundation (“PDF”). PDF receives its funding from The Michael J. Fox Foundation (the “Fox Foundation”). Both PDF and the Fox Foundation are non-profit entities and are not on the state exempt list. UCSB must collect the state 700-U form for both entities.
All disclosures must be completed, and submitted at the time of proposal submission.
For Phase I of the Small Business Innovation Research (SBIR) (R43) and Small Business Technology Transfer (STTR) (R41) projects, the PI must complete California Form 700-U and submit it with the proposal. Phase I of both SBIR and STTR programs are exempt from the federal requirements concerning disclosure of financial interests.
For Phase II of the SBIR (R44) and STTR (R42) projects, the PI and key personnel must complete California Form 700-U and the annual Federal disclosure (ORCOI). All forms are due with the submission of the proposal.
The Conflict of Interest Committee (COIC) may review consulting agreements in connection with its review of potential conflicts of interest involving research funding.
A consulting agreement is an agreement between a faculty member and a company, nonprofit entity, or governmental entity. A consulting agreement can be (a) a letter (signed by an officer of the company or nonprofit entity and the faculty member); (b) a short statement of consulting activities that is signed by the faculty member and an officer of the company or nonprofit entity; (c) a lengthier agreement signed by both the faculty member and an officer of the company or nonprofit entity, or (d) a verbal agreement. If there is no written consulting agreement, the COIC may ask the faculty member to obtain a written consulting agreement that specifies the nature of the consulting activities in detail.
The COIC review is limited to whether there is a conflict between (a) the consulting activities for a company or nonprofit entity and (b) the research being done under a sponsored research agreement from the same company or nonprofit entity. No overlap of research activities and consulting activities is allowed.
The consulting activities should not use any UCSB resources, such as personnel or space.
The COIC does not review the consulting agreement for compliance with UC policies or California law, but sometimes recommends that the consulting agreement be reviewed by the appropriate person(s) at UCSB for compliance with UC policies and California law.