Segment 4: The Challenges of Clinical Trials: Informed Consent

Abstract

Dr. Cox explains that, while in his residency at Penrose, he became interested in the issues involved when obtaining the collaboration of patients in a study. He then discusses informed consent at length, describing the issues involved and making reference to the Tuskegee syphilis case as a summary of the ethical issues at play. To demonstrate his ideas about informed consent, Dr. Cox describes a trial on cancer of the esophagus. While patients treated with radiation or surgery had some results, pairing chemotherapy with radiation therapy has such profound results that they “couldn’t ethically continue the trial.”

Dr. Cox explains that the Data Safety Monitoring Committee makes recommendations to stop any trial that is not ethically sound. Dr. Cox talks about several cases in which trials were conducted without any informed consent, and talks about the ethical and philosophical issues involved. He notes that informed consent was not a prominent issue until the 1970s, though now Institutional Review Boards are “out of hand.”