THE OFFICE OF RESEARCH

RESEARCH INVESTIGATOR HANDBOOK

4. FINDING, OBTAINING, AND MANAGING MONEY

4.5 How do I minimize financial conflicts of interest?

• What is financial conflict of interest?
• Whom do I contact if I have questions?
• What am I responsible for?
• How does UCSF determine if there is conflict of interest?
• Can I still do my research if there is a conflict of interest?
• Relevant policies and procedures

What is financial conflict of interest?

The term "conflict of interest in research" refers to situations in which financial or other personal considerations may compromise, or “have the appearance of compromising," an investigator's professional judgment in conducting or reporting research. A conflict of interest does not imply that there is research misconduct or unethical behavior.

In fact, federal regulations, state law and University policies related to conflict of interest recognize that faculty may have financial interests in sponsors of their research and/or in entities whose business interests are closely related to their research.

However, these regulations require you, as the Principal Participant, or as a investigator in the research, to disclose any potential or actual financial conflicts of interests that you may have. These conflicts must be reviewed by the Conflict of Interest Advisory Committee prior to acceptance of research funding.

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Whom do I contact if I have questions?

If you need information on disclosure policies and procedures or have questions about the financial disclosure forms, contact the COI Division at either (415) 476-5566 or (415) 502-5741.

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What am I responsible for?

As a researcher, you are responsible for the effective management of all aspects of your research, which includes managing potential financial conflicts of interest. This can best be accomplished by:

•	Accurate financial disclosures from all investigators,
•	Attention to minimizing or avoiding conflict of interest,
•	Ongoing active management of conflict of interest within your projects,
•	Assuring that your outside activities do not interfere with your faculty obligations to the University in teaching, research, and public service,
•	Assuring that no portion of time at the University is devoted to private purposes, and
•	Submitting an annual faculty report on your outside professional activities to the department chair for inclusion in your faculty record.

Note: Other investigators in your research project must also disclose any financial conflicts of interest that they may have with a funding source or with a related entity. For example, when you apply for a NIH grant, you and any of the staff who have responsibility for the design, conduct or reporting of the project must submit the disclosure form for financial and other conflicts of interest.

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How does UCSF determine if there is a conflict of interest?

COI reviews all conflicts of interest in connection with sponsored research projects (whether a contract or grant) and research gifts. The process for review is as follows:

•	You complete the appropriate Financial Disclosure forms and attach it to your funding application that you submit to the appropriate unit of the Office of Sponsored Research (OSR).
•	The OSR submits the Financial Disclosure Forms to the COIAC for its review.
•	COI reviews your information for compliance with federal and State of California laws, as well as with UC and UCSF policies.
•	COI then makes a recommendation to the Executive Vice Chancellor-Research:
	•	To accept the research funding or gift, or
	•	To accept with conditions the research funding or gift, or
	•	To disapprove the gift, grant or contract.

The COIAC review and recommendation must be completed before the University can accept funding. Allow enough time for the Office of Sponsored Research divisions (C&G, ICU, and COI ) to review your proposal packet, and for the COIAC to review the conflict. The COIAC meets on the third Thursday of each month and it requires at least two weeks to review the materials before the meeting.

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Can I still do my research if there is a conflict of interest?

In situations where the investigator may have a conflict of interest in connection with his or her research, the COIAC will determine whether the conficts can be managed or reduced, and will recommend to the Provost/Executive Vice Chancellor (EVC) specific management strategies. Some examples are (a) a reduction in percentage of ownership of stock; (b) limiting the consulting services so that they do not overlap the funded research project; (c) combining the consulting services with the sponsored research; and/or (d) disclosure to research team, in lectures, and in publications.

If your research includes human subjects, you will need to disclose the potential conflicts of interest of all investigators in your protocol application, as well as in your informed consent documents that you submit to the CHR for their review and approval.

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Relevant Guidelines and Procedures:

There are two conflict of interest guidelines issued by University of California (one in 1984 and the other in 1995, revised 1997), and there is a set of conflict of interest guidelines issued by UCSF, which are set forth in full under the policy link on the COI website.