FAQ – FREQUENTLY ASKED QUESTIONS

1. What is meant by the term “compensation” in the UCSF Guidelines on Conflict of Interest, UCOP policies on conflict of interest, state law, and federal regulations? Does “compensation” include reimbursement for travel expenses for consultations/advisory board meetings that are 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.

2. How is travel reimbursement handled?

California law requires that 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 will ask for clarification and specific details, and the COIAC will review the details.

For purposes of UCSF’s Guidelines on Conflict of Interest, item #11, travel reimbursement is excluded from the term “income.”

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3. Is there a limitation on stock ownership?

There is no specific dollar limitation of stock ownership, except as follows. Under the federal regulations, there is a disclosure threshold of 5% or $10,000 whichever is greater, in an 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.

In addition, 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.

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4. 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.

5. Is there a dollar limit on honoraria and consulting fees?

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.

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6. What is a consulting agreement?

A consulting agreement is a written agreement between a faculty member and a company or nonprofit entity. Consulting agreements do not use any UCSF resources, such as personnel or space. A consulting agreement can be (a) a letter; (b) a short statement of consulting activities that is signed by the faculty member and a company; or (c) a written agreement. There are also verbal consulting arrangements. If so, the COIAC may ask the faculty member to obtain a written consulting agreement.

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7. Who reviews consulting agreements?

Under #6 of the UCSF Guidelines on Conflict of Interest, the COIAC is required to review consulting agreements where there is a potential conflict of interest. The 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 is allowed.

If the faculty member appears to be doing the same research under the consulting agreement as he/she is doing under the sponsored research agreement, the COIAC requires that the consulting activities be rolled into the sponsored research agreement and that there be a termination of the consulting agreement. A faculty member can have a consulting agreement with the sponsor at the same time as he/she has a sponsored research agreement from the sponsor -- provided that (1) the research activities are clearly delineated in a written consulting agreement and separate from the consulting activities, and (2) the faculty member receives no income during a clinical study.

The COIAC does not review the consulting agreement (if there is one) for compliance with UC policies, but sometimes recommends that the consulting agreement be reviewed by the appropriate person at UCSF for compliance with UC policies. Please see the following website for guidance: http://www.ucop.edu/ott/pdf/consult.pdf. The School of Medicine’s webpage on consulting agreements is: http://www.medschool.ucsf.edu/academicaffairs/facultyconsulting/.

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8. Who must complete a financial disclosure form on a federal project?

UCSF employees who are deemed by the Principal Investigator to have responsibility for the design, conduct, and reporting of the research must complete a financial disclosure form. It is the responsibility of the PI to complete the Declaration page, and each person listed on the Declaration page must complete the financial disclosure form. Persons who are not UCSF employees are not required to complete a financial disclosure form (e.g., consultants who are employees of other universities, commercial enterprises, or subcontractors).

Note that there is a difference between “participant” for purposes of conflict of interest and “key personnel”. The definition of “participant” is a person who has the responsibility for the design, conduct or reporting of the research. The definition of “key personnel” is those persons who are essential for the execution of the project. The definition of “key personnel” is used by Contracts and Grants and other divisions for different purposes. Key personnel are not automatically required to complete a financial disclosure form.

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9. Can a faculty member serve on a Scientific Advisory Board during a clinical study?

A faculty member can serve on a Scientific Advisory Board of the sponsor of a clinical study during the clinical study that is funded by the sponsor. Under UCSF Guideline #11, the faculty member cannot receive income for such service. In addition, the faculty member must recuse himself/herself from discussions involving research topics related to the clinical study.

10. Are electronic signatures acceptable?

No.

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11. 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, dinner, trip to the Bahamas, 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."