Design and Analysis of Clinical Trials... Ethics of Clinical Trials Lesson 2

Introduction

Ethics of Clinical Trials

Learning objectives & outcomes

Upon completion of this lesson, you should be able to:

• State at least 3 internationally recognized conditions that are necessary to justify conducting a medical experiment in humans.
• Define the condition that is required to justify randomizing a patient to a treatment.
• Differentiate between ethical and unethical use of placebo control.
• Recognize requirements for IRB approval of human research studies involving any product regulated by the U.S. FDA.
• Recognize U.S requirements for investigators to report financial interests that may affect design, conduct or reporting of research regulated by the U.S. Public Health Service.