The Good, the Bad, and the Ugly in Human Clinical Trials
Research such as research conducted in a human clinical trial should be the systematic investigation with the purpose of contributing to a body of generalizable knowledge for the benefit of humankind. There are many important roles and responsibilities associated with human clinical trials. These range from duties owed to study participants, the roles and responsibilities of principal investigators, and the roles and responsibilities of entities responsible for the discovery of a particular compound. The lecture will explore the development of the ethical principles and regulations that protect human subjects in and outside of the U.S., key elements of a clinical trial—with emphasis on the informed consent and its process, research fraud, and real world examples of study participants stretched to the limits of agony. The lecture will culminate with the application of select frameworks towards the identification of moral imperatives in the discovery of knowledge for the benefit of humankind.
Jaime Franco, Ph.D., M.B.A., M.P.H., Assistant Professor, Department of Humanities, Health and Society, Herbert Wertheim College of Medicine, Florida International University; VP and Managing Partner, LITMUS Clinical Research Group, Miami, FL.
“WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.” (1964). World Medical Association. Web. 2 June 2015.