Principal Investigator (PI): Donald Brook

Company: ABC Pharmaceutical Co., Inc.

Proposal -sponsored project

#20-1111 - Clinical Trial Agreement - "Double-Blind, Randomized Placebo and Controlled Dose Study in the Treatment of Patients with Acute Anxiety Disorder." The PI will test the company's drug during the course of the clinical trial.

Conflict of Interest Situation

1. Relationship with Company:

The PI receives honoraria for speaking at events sponsored by the company.

The PI receives an annual consulting fee of $10,000 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: The IRC concludes that by accepting payment from ABC Pharmaceutical Co., Inc. the PI is in effect in the employ of the company. To avoid any appearance of conflict of interest in clinical trials, the PI must discontinue recompensed activities with the sponsoring company. Therefore, the IRC recommends that the PI not give company sponsored talks or consult with the company for the duration of the clinical trial.]