The ‘Catalona’ Decision And The Ownership Of Biological Samples And Clinical Data
August 11, 2006, 12:00 AM EDT
Law360 (August 11, 2006, 12:00 AM EDT) -- Each year, thousands of individuals participate in clinical trials for purposes of evaluating the safety and efficacy of medicines and medical devices. Perhaps less visible, however, is the significant portion of clinical research that does not involve the active participation of individuals but instead involves the use of biological samples and clinical data obtained from individuals and stored in repositories.
In a variety of ways, individuals provide biological samples and clinical data to a hospital, university or research institution specifically to be used in clinical research...