Institutions, Contracts, and Academic Freedom

Abstract

Clinical research in the United States is commonly performed under contracts between institutions and commercial sponsors. Often the investigator who actually does the research is not a direct party to the contract, but its language will govern the investigator's behavior with respect to the performance of the research. No matter how altruistic the motive, investigators must recognize that research performed under these contracts is a business transaction. It is imperative that the terms of such contracts guarantee the safety and confidentiality of patients while preserving the academic independence of participating investigators.