Overview
Per UCSF policy, all researchers (those "responsible for the design, conduct, or reporting of research") are required to have an annual disclosure on file in Research Gateway, regardless of whether their projects are federally- or privately-funded.
Additionally, principal investigators of privately-funded research projects must also complete the Form 700U.
What Must be Disclosed?
Investigators who engage in sponsored research (regardless of funding type) at UCSF are required to disclose all Significant Financial Interests (SFIs) related to their Institutional Responsibilities.
Significant Financial Interest means a financial interest consisting of one or more of the following interests of the Investigator or the Investigator’s spouse or registered domestic partner and any dependent children for the following categories:
- With regard to any publicly-traded entity, a Significant Financial Interest exists if the value of any remuneration (other than remuneration described in Paragraph E, below) received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are salary (other than salary described in Paragraph E, below), consulting fees, honoraria, and the equity interest value at the date of disclosure as determined by public prices or other reasonable measure of fair market value.
- With regard to any non-publicly-traded entity, a Significant Financial Interest exists if the value of any remuneration (other than remuneration described in Paragraph E, below) received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse, registered domestic partner, or dependent children) holds any equity interest (including stocks, options, etc.)
- Receipt of income from intellectual property rights and interests exceeding $5,000 during the twelve months preceding disclosure. However, Significant Financial Interests do not include royalties received from the University of California Regents.
- Travel reimbursements made to, or on behalf of, the Investigator, regardless of the amount, by a for-profit or nonprofit entity, excluding a federal, state, or local government, a U.S. institution of higher education or an affiliated medical center/hospital or research institute. Only the Investigator’s travel reimbursements are included in the definition of Significant Financial Interest. Therefore, the Investigator’s spouse or registered domestic partner, or dependent children’s travel reimbursements are not considered to be a Significant Financial Interest in this policy.
- Any intellectual property not held by the UC regents, or any intellectual property interest in the form of a patent, patent application or copyright held by the investigator, assigned or to be assigned to a party other than The Regents.
- A management position, whether paid or unpaid, such as a board member, director, officer, partner, or trustee.
The term “Significant Financial Interest” does not include the following types of financial interests:
- Mutual funds or other investment vehicles such as retirement funds as long as the Investigator does not directly control the investment decisions made for these investment vehicles;
- Salary, stipends, royalties, honoraria, reimbursement of expenses, or any other payments made by the University of California Regents to a University of California Investigator who is currently employed or otherwise appointed by the University;
- Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by a federal, state, or local government, agency, a U.S. institution of higher education, or a research institute, academic medical center or hospital affiliated with an institution of higher education;
- Travel that is reimbursed or sponsored by federal, state or local governments, a US institution of higher education, or a research institute, academic medical center or hospital that is affiliated with an institution of higher education.
How do I Disclose a Significant Financial Interest?
All COI disclosures are completed in Research Gateway.
- Log into Research Gateway via MyAccess.
- Open the COI menu and click the Disclosures tab.
- Under the Instruction Center, click Edit Disclosure Profile.
- Read the Instructions and Policies page and the UCSF FCOI training. Check the box to confirm training completion, then click Continue.
- On the Entity Disclosure Information page, select Yes or No to indicate if you have anything to disclose. (If No, skip to step #11.)
- If Yes, an additional table appears where you identify the entity with a financial interest.
- Click + Add to open a new window.
- In the new window, enter the entity's name and select it from the list. (If it's not listed, use the ... button to add it.)
- Select the radio button for the individual with the financial interest, and choose the relevant disclosure types.
- Fill in the required information about your financial interest. Click OK when done, or OK and Add Another if you have more to disclose.
- After disclosing all financial interests, click Continue.
- On the Complete Disclosure Profile page, submit your disclosure by clicking Complete Disclosure Profile Update and then selecting OK in the pop-up window that populates. (To submit later, click Finish or Save.)
Determining "Direct Relatedness" to a Research Project
It is important to note that all significant financial interests must be disclosed on your annual conflict of interest disclosure, regardless of whether they are "related" to the project. For example, an investigator's $50,000 equity interest in a private telehealth company may have no relation to their sole research project studying outcomes of a vaccine, but it should still be reported.
Once significant financial interests are disclosed, our team (and other departments) may ask for confirmation regarding whether a particular significant financial interest is "directly related" to a particular research project. In simplest terms, to be considered "directly related" to a research project, the significant financial interest has to be connected to the project somehow. This connection would exist in the following instances:
- The entity in which the financial interest is held is funding the research project
- The entity in which the financial interest is held has a subcontract with/for the project
- The entity in which the financial interest is held is somehow otherwise involved in that research project (providing supplies or services for the project, etc.)
Having a significant financial interest that is directly related to a research project does not automatically mean you must remove yourself from the project. Our team will work with you to manage any conflicts.
If you are unsure whether your significant financial interest is directly related to a research project, contact COIAC@ucsf.edu external site (opens in a new window) .
Completing a 700U for Privately Funded Research
Requirements
The Statement of Economic Interest Form (700-U) must be completed when a funding is given to the University of California San Francisco (UCSF) or to the UCSF Foundation from a non-governmental entity for a specific research project or for use by specific faculty member(s) for a specific purpose. Non-governmental entities include private business partnerships, LLCs, corporations, and non-profit foundations. Matching gifts and gifts from Donor Advised Funds for specific research or use by specific faculty member(s) for a specific purpose are also subject to 700-U requirements. The 700-U Form must be completed only by the Principal Investigator or by the lead faculty member.
Exemptions
View a list of sponsors exempt from the 700-U Form requirement external site (opens in a new window) on the UC Office of the President website.
Incomplete forms or those containing positive disclosures will require review by the Conflict of Interest Advisory Committee (COIAC). Pending this review, the funds cannot be accepted.
Instructions
Per Adopt 2 Cal. Code Regs. Section 18104, the 700-U Form may be completed in paper format with the filer’s handwritten signature OR in electronic format with the filer’s secure electronic signature. To comply with regulatory requirements, the secure electronic signature must be provided via DocuSign. Please refer to UCSF’s Electronic Signature information external site (opens in a new window) about UCSF’s DocuSign. You may submit a request to use another form of secure electronic signature to the Conflict of Interest Unit within the Office of Ethics and Compliance (OEC). However, please note that other forms of electronic signature require pre-approval and may delay the review process.
If the 700-U Form is completed in paper format with the filer’s handwritten signature, the original documents must be mailed to the Conflict of Interest Unit within (OEC) (see below for instructions). If a secure electronic signature is collected via DocuSign, there is no requirement to mail the 700-U Form to the Conflict of Interest Unit.
If providing handwritten signature, please send the original, signed and completed 700-U form to:
Office of Ethics and Compliance
c/o COI Program
490 Illinois Street, Box 0294
San Francisco, California 94143-0294
If you have questions, please contact COIAC@ucsf.edu external site (opens in a new window) .