Office of Clinical Trials Research

Safety and Confidentiality

Clinical Trials are overseen by several groups including:

• Institutional Review Board (IRB) - All research studies have to be approved by the IRB, also known as an ethics committee. The IRB reviews all projects and provides approval for the investigator to make the study available to patients. This board consists of physicians, scientists, nurses, and non-medical persons.
• Food and Drug Administration (FDA) - The FDA reviews safety data of new drugs and regulates all drugs being tested.
• Study Sponsor - The Pharmaceutical company or cooperative group (large cancer center) who offers the study.
• Principal Investigator - The physician who directs the study at the university, hospital or doctors office.
• Research Nurse - The person who coordinates the trials and explains them to the patients.