Case Study #3 - No Separation of Interests
Facts:
UCI Professor Bright submits a contract for a proposal studying the effects of the bacteria, R. ednous on oil based compounds. Professor Bright is a founder and has a 35% ownership in a start-up company, Clean Up, Inc. Clean Up, Inc. owns the use patent on R. ednous for this specific application. In her proposal packet, Dr. Bright provides a list of her publications and details all current research conducted in her lab. You note that Dr. Bright's support and lab research primarily consists of two UC Discovery projects with Clean Up studying R. ednous and its effect on both residential and commercial oil based compounds. Dr. Bright has only co-authored a few publications within the past four years. As you are reviewing Dr. Bright's disclosure, her MSO calls concerned about Dr. Bright's allocation of time on Clean Up's research. She asks you what your assessment is of Dr. Bright's financial relationship with Clean Up.
Issues:
Given Dr. Bright's role as founder of Clean Up and her 35% stock ownership, has she created an unmanageable conflict of interest by focusing all of her UCI research on Clean Up's research. Also, does her 35% ownership in Clean Up constitute an unmanageable conflict of interest
Rules:
State policy requires that a principal investigator maintain a separation of interest between their private interest and their work at their research institution. Pertaining to stock ownership, the COIOC typically limits allowable equity interests to 10% of a company's overall equity holdings, but conducts each COIOC review on a case-by-case basis.
Potential Risks:
In its review of Dr. Bright's financial interests, the COIOC will focus heavily on the fact that most of Dr. Bright's research support comes from Clean Up. Also, Dr. Bright's lack of recent publications and her 35% stock ownership will raise a red flag for the Committee. Dr. Bright's activities potentially place the institution at risk in a number of ways. At a first glance, it appears that there is no separation of interest between Dr. Bright's UCI research and that of Clean Up's. Considered individually, her UC Discovery projects do not pose a significant risk. However, as a whole and in conjunction with the fact that all of her research support is derived from Clean Up, there appears to be little separation of interest. Also, the fact that Dr. Bright has not published in four years, would raise concerns as to the openness of her research.
Rationale:
While it seems that Clean Up and Dr. Bright may be working under appropriate contracts and the University is thus, being reimbursed appropriately, as a whole, there appears to be no separation of interests. Given the allocation of time and resources spent on Clean Up, Inc.'s research, Dr. Bright may not be separating her UCI interests from that of Clean Up's. Because she owns a significant portion of Clean Up's stock and her research at UCI focuses primarily on Clean Up's research, the potential for a harmful conflict of interest is present. Given the above circumstances, the Committee will most likely find Dr. Bright's interests unmanageable.
