UCSB’s Conflict of Interest review process is governed by federal, state and U.C. regulation and policy. 

The Public Health Service (PHS) and the National Science Foundation (NSF), or any institution that follows their COI policies, require that the lead Principal Investigator (PI) on funded projects identify project Investigators. Those Investigators are required to disclose their significant financial interests, and each disclosure must be reviewed before funds may be spent.

An Investigator includes anyone who can directly or materially influence the research, or who is responsible for the design, conduct, or reporting of such research, and is not limited to Key Personnel. The lead PI should make the determination of who is an Investigator for every proposal submission, continuation, personnel change or no cost extension via the Key Personnel tab on the ORBiT datasheet.

The Key Personnel tab is located in ORBiT on the record’s datasheet which is accessed by  the department contracts and grants liaison. At the initial proposal submission, the contracts and grants officer will check with the lead PI to confirm that all investigators are accurately listed on the key personnel section. The same process will be followed at the award stage and for each continuation or a no cost extension to ensure the form includes an up-to-date list of all investigators.

Below is a quick reference to help PIs in identifying investigators:

Roles Investigator? Guidance
Principal Investigator Yes  
Co-PI Yes  
Postdoctoral Scholars Almost Always When a postdoc's role on a project involves a significant degree of autonomy and responsibility, they should be listed as an Investigator.
Graduate Student Researchers Occasionally Graduate students are considered an Investigator when they receive a fellowship for a project that they lead. Graduate student researchers working on faculty-led projects do not meet the definition of Investigator.
Other Roles Situational These individuals should only be considered Investigators if they are responsible for the design, conduct, or reporting of the research project. 

 

Investigators on NSF funded projects must disclose project-related significant financial interests at the proposal submission stage and on an annual basis. Investigators must also disclose the financial interests of their spouses/registered domestic partners and/or dependent children. This requirement also applies to subawards*.

The lead PI is responsible for accurately classifying the individuals on a project based on their roles that meet the definition of “Investigator.”

The NSF Conflict of Interest Policy defines Investigator as “the PI/PD, co-PI/co-PDs, and any other person identified on the proposed project who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF.”

All investigators on an NSF funded project must:

  1. Be listed in the Key Personnel section of ORBiT, and
  2. Submit an NSF annual disclosure in the Office of Research Conflict of Interest (ORCOI) system found at https://orcoi.research.ucsb.edu.

  Investigators must have a disclosure on file:

  • At initial proposal, continuation, renewal, supplement, or when requesting a no-cost extension,
  • Within 30 days of being added to a project, 
  • Within 30 days of any change in an investigator’s financial interest, and
  • Annually throughout the duration of the project.

If an Investigator marks “yes” to any question on the disclosure, it will be considered a “positive” disclosure. The COI administrator will reach out to the investigator for additional clarifying questions or request they submit an “Addendum” form via https://orcoi.research.ucsb.edu. The Addendum together with the original NSF Annual Disclosure will be reviewed by the faculty Conflict of Interest Committee. 

*For any non-UCSB Investigators on the UCSB proposal/award and any subrecipients following UCSB’s NSF COI policy, all individuals who meet the definition of an Investigator must complete the Subrecipient DCR Form and submit their annual disclosure through ORCOI.

The U.S. Department of Health and Human Services (HHS) Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R., Part 50, Subpart F) covers the requirements for disclosure, review, management and reporting of financial interest in PHS-funded research.

All investigators on PHS-funded projects must disclose significant financial interests related to their institutional responsibilities. Investigators must also disclose the significant financial interests of their spouses/registered domestic partners and/or dependent children. This requirement also applies to subawards*

The University of California defines Institutional responsibilities as including teaching/education, research, outreach, clinical service, and University and public service on behalf of the University of California which are in the course and scope of the Investigator’s University of California appointment/employment.

Investigators are defined as principal investigators, project directors, senior/key personnel, and any others, e.g. postdocs, who are responsible for the design, conduct or reporting of PHS-funded research in a substantive, measurable way, whether or not they receive salary or other remuneration. 

The categorization of “Investigator” must consider the roles of those involved in research and the degree of independence with which those individuals work. Investigators are not limited to those listed as senior or key personnel. The NIH has a FAQ on this topic here.

An Investigator on a PHS funded project must: 

  • Be listed in the Key Personnel section of ORBiT, 
  • Submit an annual disclosure in the Office of Research Conflict of Interest (ORCOI) system found at https://orcoi.research.ucsb.edu, and
  • Complete the Compliance & Conflict of Interest Training for Researchers Briefing (COIR) via the UC Learning Center every four years.

 Investigators must have a disclosure on file:

  • At initial proposal, continuation, renewal, supplement, or when requesting a no-cost extension,
  • Within 30 days of being added to a project,
  • Within 30 days of any change in an investigator’s financial interest, and
  • Annually throughout the duration of the project.

If an Investigator marks “yes” to any question on the disclosure, it will be considered a “positive” disclosure. The COI administrator will reach out to the investigator and request they submit an “Addendum” form via https://orcoi.research.ucsb.edu. The Addendum together with the original PHS Disclosure will be reviewed by the faculty Conflict of Interest Committee. 

*For any non-UCSB Investigators on the UCSB proposal/award and any subrecipients following UCSB’s PHS COI policy, all individuals who meet the definition of an Investigator must complete the Subrecipient DCR Form, submit their annual disclosure through ORCOI, and complete the NIH COI training.

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://orcoi.research.ucsb.edu).

Submit a copy of the Form 700-U to Gift Administration, with the original check and original paperwork required by Gift Administration.

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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, when funded by a Public Health Service agency, 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.

For detailed information about these two small business programs, please see An Entrepreneurs Startup Guide developed by the Technology and Industry Alliances Office.

MTA's are processed through Technology and Industry Alliances (TIA) and any related COI disclosures should be made through ORCOI (https://orcoi.research.ucsb.edu). 

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.

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.

Best Practices

Transparency is an essential element for maintaining the public’s trust in scientific research. As researchers are increasingly encouraged to engage in entrepreneurial activities related to their university research, it is vital for researchers to proactively identify potential conflicts of interest and ensure transparency between their university and outside activities and interests. 

In accordance with relevant federal, state and university policies, the Conflict of Interest Committee recommends that Investigators with Significant Financial Interests related to their research adhere to the following best practices. Implementing these best practices is an important step in ensuring transparency and mitigating the perception of a conflict of interest in matters relating to sponsored research.

 

A. Public Disclosure in Publication/Presentations 

Investigators should disclose their significant financial interest(s) in an outside entity in any publication(s) resulting from research that relates to that financial interest. Academic journals routinely require authors to disclose competing interests, and it is important to closely follow the specific journal’s requirements. 

B. Safeguarding Intellectual Property

Investigators should be familiar with university policy relating to intellectual property and take all necessary steps to protect against inappropriate disclosure of research information and intellectual property by promptly disclosing to the Office of Technology and Industry Alliances the development of new or improved technologies, inventions, innovations, creations, or discoveries in the course of this sponsored research.  Investigators should refer to guidance on the Technology & Industry Alliances website.

C. Protection of Students and Postdoctoral Scholars

An Investigator’s involvement with an outside entity must not be allowed to unduly influence or restrict the academic or research choices of their graduate students and postdoctoral scholars.  To assist in this, the Investigator will disclose their relationship with the entity, in writing, to all graduate students and postdoctoral scholars under their supervision or direction participating in this project and will be particularly diligent in allowing students to publish in a timely manner. Investigators and graduate students should be familiar with the Graduate Division’s Policy on Conflict of Interest in Graduate Education

D. Investigator Responsibility Regarding Disclosure to Unit

Pursuant to University of California Policy on Outside Professional Activities (APM-025), any Investigator subject to this policy must disclose all activities to their department that may create a potential conflict of commitment. Category I activities may not be initiated without prior approval.

E. Collaboration with a Foreign Entity, Institution or Government

International collaboration is encouraged and is an important part of our research mission. If the project involves collaboration with a foreign entity, institution or government, the PI must be aware of sponsor requirements to report certain foreign research support and foreign components. The Investigator should review guidance on the Other Support webpage