ATTACHMENT IV:

Financial Conflicts of Interest in Clinical Research:
Management Approaches

The University of California 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 are examples of actions that may be taken by the campus to eliminate, reduce, or manage a financial conflict of interest. Such actions include, but are not limited to:

1. Monitoring of the project by independent reviewers;
2. Modification of the research project or plan;
3. Disqualification from participation in all or a portion of the project;
4. Divestiture of the relevant financial interest(s); and/or
5. Severance of the relationships that create actual or potential conflicts.

A prohibition on accepting any income from a sponsor for honoraria, travel, consulting, or other activities during the conduct of a research study is, standing alone, not generally an appropriate management approach.