Session 4: Discussion Paper - Whistleblowing, Clinical Trials, and the Academy: Some Recent Ethical and Public Policy Considerations

Paul Gallina - Whistleblowing, Clinical Trials, and the Academy: Some Recent Ethical and Public Policy Considerations
Williams School of Business and Economics, Bishop's University, Lennoxville, QC J1M 1V7 Canada

This paper reviews some ethical and public policy issues in the case of whistleblowing and Dr. Nancy Olivieri in light of the recent Report of the Committee of Inquiry sponsored by the Canadian Association of University Teachers. At issue in the case is the right of participants in a clinical trial to be informed of a risk that has been identified during the course of the trial by the investigator, and the obligation of the investigator to inform them.

It is argued that the facts of Dr. Olivieri's case fit the classic model of whistleblowing: dissent; breach of loyalty; and, accusation. In the literature of business ethics, whistleblowing has been ordinarily assessed from a utilitarian calculus, and a consequentialist approach. However, it is argued consistent with the Report that the correct approach in this instance is an intentionalist one, independent of the consequences that could not be foreseen. Dr. Olivieri had a duty to report her findings consistent with her Hippocratic Oath.

Furthermore, the paper supports the Report argument that in the interest of the public interest, and academic freedom, hospital staff who hold academic appointments are who conduct clinical trials should not be asked to sign legal confidentiality agreements. As a further public policy consideration, given the failure of the Research Ethics Board, it is argued that an independent body of appeal be established that could hear disputes without prejudice to the participants.