Conflict of Interest

Financial Conflict of Interest Compliance

What is a Conflict of Interest?
700-U Form (Non-Governmental Source)
Form 800 for Projects Involving Human Subjects and/or NSF Funded
PHS (Federal Public Health Service) and DOE (Department of Energy) FCOI Regulations
Policies

What is a Conflict of Interest?

A Conflict of Interest (COI) is a situation in which an investigator’s outside financial interest(s) or obligation(s) (real or perceived) have the potential to bias a research project or cause harm to human subjects participating in a research project. Investigators at UC Agriculture and Natural Resources are subject to University of California system wide policies, as well as specific State of California law and federal regulations regarding COI requirements.

The Office of Contracts and Grants (OCG) is the office of record for Financial Conflict of Interest disclosures related to sponsored funding. For any positive disclosures which requires Conflict of Interest Committee review, OCG will coordinate with the Conflict of Interest Committee which is responsible for the review and assessment of all financial disclosures related to research projects at UC ANR and for determining any actions required to ensure that real or perceived financial conflicts of interest are managed or eliminated.

Click here to learn more about Conflicts of Interest.

Please contact the Office of Contracts and Grants at OCG@ucanr.edu for more information on any of the COI forms or requirements outlined below.

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1. Statement of Economic Interests (700-U) Form (Non-Governmental Source)

State of California law requires disclosure of financial interest in the sponsor of a research project when that sponsor is a non-governmental source. The Form 700-U is required to be completed by the Principal Investigator within 3 months prior to the acceptance of an award. Per the State of California original signatures are required on the Form 700u and the original copy must be received by the Office of Contracts and grants prior to acceptance of the award.

List of Non-governmental Entities Exempt From Disclosure Requirement.

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2. Financial Disclosure Form for Projects Involving Human Subjects and/or Federal (Non-PHS or DOE) Funds (Form 800)

The Form 800 is to be completed if your project involves Human Subjects or is funded by a Federal (non-PHS or DOE) entity, CIRM, or UCOP Special Programs. In accordance with the University of California Policy on Disclosure of Financial Interests, the Principal Investigator and all other UC ANR investigators (all persons who have responsibility for the design, conduct or reporting of research) must disclose their personal and family member’s significant financial interests. The Form 800 must accompany the proposal and be submitted to the Office of Contracts and Grants. (Form can be completed on the Workflow Automation Application. Link to Quick Guide reference for new system.

In the event of a ‘Yes’ Answer on the Form 700u or the Form 800 (1 or 2 above), the Disclosing Investigator should also complete the Statement of Economic Interest Supplemental Form in order to provide OCG and the Conflict of Interest Committee with the details needed for the members to make a fully informed decision about any real or perceived conflicts of interest.

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3. Federal Public Health Service (PHS) and Department of Energy (DOE) FCOI Regulations (PHS COI Form 1)

Disclosure Requirements:

The Public Health Service (PHS) and Department of Energy (DOE) requires disclosure of significant financial interests by investigators who participate in PHS or DOE funded research either directly or via subaward. Other foundations and agencies have also adopted the PHS requirements which can be found here.

The Office of Contracts and Grants has developed a three-stage process to implement the disclosure, review, and reporting requirements of the PHS financial disclosure regulations. In an effort to reduce the administrative burden on both investigators and COI Committee staff at the time of proposal, more detailed financial information regarding a ‘Yes’ answer on the Form 1 will not be collected unless and until a proposal is likely to be funded, generally when a Just-in-Time (JIT) or similar request is received.

New or Competing Continuation/Renewal Proposals

Step 1

At the time a proposal is submitted any individual on the proposed project who has been named as an investigator is required to complete and sign the PHS/DOE Financial Disclosure (Form 1) regarding the disclosure of Significant Financial Interests (SFI). “Investigators” are defined by PHS/DOE to include principal investigators and any other individual who, regardless of title or position, who has responsibility for the design, conduct, or reporting of such covered research.

Forms to be submitted at the time of proposal to OCG:
1) PHS/DOE COI Form 1
2) PHS/DOE COI: Principal Investigator Certification form
3) PHS/DOE COI Training: "UC General Compliance Briefing: University of California Ethical Values and Conduct" (to be completed through the UCD Learning Management System)

A proposal will not be considered complete and cannot be submitted to the funding agency by the OCG unless required financial disclosures are in place.

Step 2

If it is indicated that the proposal is likely to be funded and when the Form 1 has “yes” responses, those investigators with “yes” responses will be contacted by the OCG to request completion and submission of the PHS/DOE Financial Disclosure (Form 2). Form 2 contains a set of questions, the answers to which will be used by the COI Designated Official to determine whether or not a disclosed SFI is related to the research project to be funded.

Step 3

If it is determined that the disclosed SFI is related to the project, the investigator will be notified by the COI Coordinator to complete a PHS/DOE Financial Disclosure (Form 3). Form 3 contains a set of questions developed to determine the extent to which the identified SFI may directly and significantly affect the design, conduct or reporting of the PHS/DOE-funded research project. The COI Committee will review the PHS/DOE Financial Disclosure (Forms 1 - 3) in conjunction with the proposal and any other information, to decide whether the related SFI constitutes a financial conflict of interest (FCOI) under the regulations. If it is determined that an FCOI exists, then the COI Committee will develop an appropriate management plan with the purpose of providing reasonable expectation that the FCOI of the investigator(s) will not bias the research results of the PHS/DOE-funded research. That management plan requires the signed concurrence of the investigator(s) with the FCOI. The COI Coordinator will then report required details of the FCOI to the NIH (or the prime awardee if UC ANR is a subrecipient.) FCOI’s must be reported to NIH prior to the expenditure of funds. PIs and investigators must plan for sufficient processing and review time.

***New Investigators: The Principal Investigator is required to submit a PHS/DOE Financial Disclosure Form 1 for any new UC ANR investigator added to this project in the future, and may not use project funds to support any UC ANR investigator who makes a positive disclosure until the UC ANR COI Committee reviews and approves this disclosure.***

Annual Disclosures and Updates to Existing Disclosures

Regulations require both annual financial disclosures and that updates to existing disclosures be made within 30 days after acquiring or discovering a financial interest that must be disclosed as defined by PHS/DOE. These updated disclosures must be made by all investigators, including those of any subrecipient who is relying on UC ANR’s PHS/DOE-compliant policy.

On an annual basis or within 30 days after acquiring or discovering a financial interest, the Form 1 must be completed by all investigators and provided to the Office of Contracts and Grants. Any investigators with a “yes” response to any of the questions on Form 1 must complete and submit Form 2 at this same time. These disclosure documents will serve as the required annual disclosure for investigators who have disclosed previously. At the time of a non-competing continuation proposal, progress report, no-cost time extension, or modification extending the end date, if an annual disclosure has not already been made within the past 12-months, the UC ANR PI must also provide OCG with a newly signed PHS/DOE FCOI.

If it is determined that a disclosed SFI is related to the research project to be funded, the COI Coordinator will request from those investigators that PHS Financial Disclosure Form 3 be completed and the COI Committee will review the PHS/DOE Financial Disclosure as outlined above to decide whether the related SFI constitutes a financial conflict of interest (FCOI).

***NOTE: The Office of Contracts and Grants will not release an award until all investigator financial disclosures have been received, reviewed and approved and the PI has certified that all investigators on the project have completed the PHS/DOE-compliant training.***

Training Requirements:

All Investigators are required to take PHS/DOE-compliant training prior to engaging in PHS/DOE-funded research for new awards, whether receiving remuneration or not, and at least every four years while engaging in PHS/DOE-funded research. This training requirement applies equally for those funding agencies that have adopted the PHS regulations. The training requirement must be met as follows:

UC General Compliance Briefing: University of California Ethical Values and Conduct is available through the UCD Learning Management System

Go through the training to complete the course.
After you have completed the training, print the certification form and email it to the analyst assigned to the project at OCG. Keep a copy for your records.
In addition, all Investigators should complete the on-line training provided by NIH for PHS funding.

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UC Policy

PHS Policy

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