Below you will find three sets of Frequently Asked Questions providing essential information regarding Conflict of Interest at UCSF:
FAQs Regarding the PHS Rule
General UCSF FAQs Regarding UCSF COI
For purposes of conflict of interest, what is "compensation"? Does it include reimbursement for travel expenses for consultations/advisory board meetings, not otherwise covered by the research project budget? Compensation includes personal income, honoraria, and consulting services’ fees that are received from sources outside the University. Sometimes, depending upon Department policy, the compensation must be turned over to the Department. Salary received from the University is not “compensation” for purposes of conflict of interest policies.
How is travel reimbursement handled? California law, and federal regulations, require that certain travel reimbursement be reviewed by the COIAC. When a faculty member has received travel reimbursement that is not covered by the research project budget, he/she checks question #3F on Form 700-U. Travel reimbursement is then reviewed by the COIAC. If the only money received is travel reimbursement, please do not check “yes” to question #3C on Form 700-U. Question #3C covers personal income such as consulting income or honoraria – not salary or travel reimbursement. Because travel reimbursement given to a faculty member is deemed to be either “gift” or “income” under California law, the UC administration has recommended two solutions to avoid application of the California law: (a) the travel reimbursement should be anticipated and rolled into the project budget; or (b) UCSF should invoice the private company (or non-profit sponsor), which then pays the invoice, and UCSF reimburses the faculty member. When a faculty member reports excessive travel reimbursement, the COI staff my ask for clarification and specific details, and the COIAC will review the details.
Is there a limitation on stock ownership disclosure? There is no specific dollar limitation of stock ownership, except as follows. Under the federal regulations, there is a disclosure threshold of $5,000 in a publicly-traded entity that has a related interest to the federally sponsored research. Under California law, the disclosure threshold is $2,000. Disclosure equal to or above these disclosure thresholds are reviewed on a case-by-case basis by the COIAC, and a recommendation is made to the Executive Vice Chancellor & Provost. Investment in any privately-held companies of any amount requires disclosure. In addition, Appendix IV of the Faculty Handbook provides additional guidelines. Under the UCSF Guideline #11 (the clinical study policy), there can be no income or investment in the sponsor-company during a privately sponsored clinical study. Under UCSF Guideline #10, a faculty member who has an investment in a company which is 5% or more of the total value of the company cannot receive research funding from that company, except if the funding is under an SBIR/STTR grant. Under UCSF Guideline #9, a faculty member cannot serve on the Board of Directors of a company at the same time that he/she receives research funding from that company, except if the funding is under an SBIR/STTR grant.
Is there a difference if the stock were included in a portfolio run by a mutual fund? There is no requirement that stock owned through mutual funds be disclosed. If it is disclosed, the COIAC does not consider it to be a conflict of interest, because ownership of stock managed through a mutual fund is considered to be indirect ownership where the faculty member has no control over the business of the company
Is there a dollar limit on honoraria and consulting fees disclosure? Honoraria and consulting fees must be disclosed if they equal or exceed the federal or state dollar thresholds. These disclosures are considered on a case-by-case basis by the COIAC. Honoraria include compensation for writing articles or giving lectures for a privately sponsored symposium or CME event. Honoraria and consulting fees of any amount from the company sponsoring a clinical study are not allowed under the UCSF clinical study policy item #11.
Who must complete a financial disclosure form on a federal project? For federally funded research or research funded by an entity that has adopted the federal regulations. All researchers who have the responsibility for the design, conduct, and reporting of the research. Investigator who has a potential conflict must must disclose financial interests at the time of proposal. Persons who are not UCSF employees may not be required to complete a financial disclosure form. Consultants and employees of other universities, commercial enterprises, or subcontractors are covered by their own policies and reviewed at their own entities.
Can a faculty member serve on a Scientific Advisory Board during a clinical study? A faculty member may serve on a Scientific Advisory Board of the sponsor of a clinical study during the clinical study that is funded by the sponsor with the approval of the COIAC. Under UCSF Guideline #11, the faculty member cannot receive income for such service. In addition, the faculty member may be required to recuse himself/herself from discussions involving research topics related to the clinical study.
Are electronic signatures acceptable? Yes, on all COI forms except California Form 700-U. California law requires that the original hard copy of Form 700-U be printed, signed, and dated.
What is meant by "gift" in question #3E on Form 700-U? In this question #3E, “gift” means a personal gift to a faculty member, such as a briefcase, bottle of wine, and so forth. Please do not include information about a gift to the University from a private company or nonprofit entity that is designated for a particular faculty member or particular research. Those gifts are gifts to the University. Gift payments are typically made payable to "the Regents of the University of California."