Principal Investigator (PI): Jean Poole

Company: ABC, Inc.

Patents (3) PI holds three patents: "Gene Therapy for Lung" "Gene Therapy for Lung" "Pulmonary Gene Therapy"

Proposals (NIH)

#91-0001 - "Mechanisms and Approaches in Pulmonary Failure." This research involves gene transfer of ABC in cloning ABC by testing patients. The research is directly related to company.

#91-0101 - "Physiology of Lung Disease." This research involves gene transfer of ABC. The proposal does not mention ABC directly. However, it does mention gene programs.

The proposed research is likely to identify genes as targets for drug delivery. In effect, this proposal asks the NIH to support the development of a company's potential product using a federal research grant to an academic investigator.

Conflict of Interest Situation

1. Relationship with Company:

The PI is the founder and President of the company.

She has 25% equity in ABC, Inc.

PI receives an annual consulting fee of $150,000 and has a consulting agreement with the company.

How would you manage this conflict of interest?

[IRC Recommendation for Management of the Conflict of Interest: IRC asked PI to resign from her management position in the company and discontinue her consulting activities for the duration of the project. IRC also asked for the PI to write to the sponsor and sever her relationship for the duration of the project. IRC asked the PI to accept a third party review of the company's research to ensure that UC intellectual property was not compromised. An Ad Hoc Panel was assigned to review the PI's progress. PI was asked to acknowledge her relationship with the company on all publications deriving from this research.]