ATTACHMENT III:

Financial Conflicts of Interest in Clinical Research:
Guidelines for Faculty

The University of California initially established a policy on disclosure of financial conflicts of interest in response to State of California laws and regulations dealing with conflicts of interest. As part of this policy, University researchers who have a financial interest in a non-governmental entity that sponsors (by gift, grant, or contract) their research must disclose that financial interest by completing and submitting a State mandated Form 730U for review by UCLA's Independent Substantive Review Committee or "ISRC." As part of its review, the ISRC recommends to the Vice Chancellor - Research that the gift, grant, or contract in question be accepted, accepted with conditions, or rejected. In making his final determination, the Vice Chancellor - Research may accept the ISRC's recommendation or impose additional or different conditions on the campus' acceptance of the gift, grant, or contract. The following guidelines are intended to assist faculty better to understand financial conflicts of interest in clinical research and their reporting obligations.

Guideline 1: The role of the investigator and key personnel in the design, conduct, data analysis, and reporting of a study is an important determinant of the degree of concern in reviewing a financial conflict of interest. When investigators or key personnel are able to meaningfully influence the course of a study, significant financial interests in the sponsor should be carefully evaluated and appropriate steps taken to eliminate, mitigate or minimize such conflicts.

Guideline 2: The nature of a study (i.e., multi-center, single-center, sponsor-initiated, researcher-initiated) may alleviate the level of concern created by a conflict of interest disclosed by the investigator or key personnel.

Guideline 3: The nature of the investigator's financial interest in the sponsor is an important consideration in evaluating a conflict of interest. Many institutions have established thresholds of financial involvement, which, when exceeded, must be addressed. For example, ownership greater than 5% of stock issued by the sponsor or $50,000 of equity, whichever is less, or greater than $10,000 in annual income from the sponsor (regardless of the services performed) may trigger consideration of steps to minimize or eliminate conflict or interest or its appearance (these threshold need to be reviewed on a regular basis). In addition, the University needs to ensure that support to the investigator through the gift/grant/contract is reasonable and proportionate to the required work. Although there may be exceptions, the following activities, undertaken within such thresholds, are not deemed to create serious conflicts of interest:
a. Service on advisory boards or scientific advisory boards, with or without financial compensation;
b. Service as a consultant, whether in the investigator's area of research sponsored by the non-governmental entity or other areas, with or without financial compensation;
c. Income from speaking or payment for travel and living expenses incurred during travel; or
d. Equity holdings (including stock options) in the non-governmental sponsor, if the sponsor is a publicly traded company.

Guideline 4: The number and/or monetary value of the financial interests of the investigator or key personnel, and their respective roles in the design, conduct, data analysis, and/or reporting of the results will affect the ISRC's assessment and disposition of a financial conflict.

Guideline 5: Certain financial interests shall, absent compelling circumstances, be presumed to be unacceptable:

a. Stock options if the investigator or key personnel is responsible for subject recruitment; and
b. When the inventor or developer of the drug/device/technology being studied or tested has any financial interest in the commercial development of the drug/device/technology, he/she may not participate in the design, conduct, data analysis, or interpretation of results. Such individuals may participate in other aspects of such research or testing subject, however, to conditions imposed by the campus.

Guideline 6: When the ISRC determines that financial conflict of interest exists, disclosure of the conflict in publications and presentations will generally be required, regardless of the practice of the publication or event organizers.