ABSTRACT
The "Olivieri case" was a high-profile series of ethical disputes concerning multiple institutions and individual researchers involved in the clinical research on a new drug. The case highlights the ethical dilemmas involved and asks students to consider how they would respond if placed in a similar situation. The contract included confidentiality, communication and intellectual rights clauses and the level of profits that would accrue to the company in exchange for continued funding for the clinical trials. The funding requirements were exceptionally high and could only be fulfilled through a corporate sponsor. Dr. Koren negotiated an arrangement with Apotex Incorporated, which agreed to acquire the commercial development rights for L1 and to sponsor the clinical drug trials. The university was drawn into the conflict between Dr. Olivieri and Apotex because two key ethics principles were in contention: academic freedom and the rights of participants in a clinical trial and their parents to be informed of risk.
