How are drugs approved? Part 2: ethical foundations of clinical research

In the United States, the U.S. Food and Drug Administration (FDA) evaluates and approves drugs through a process that includes clinical research. The purpose of clinical research is to diminish uncertainty by acquiring knowledge. For drug development, the goal is to approve drugs that are safe and effective. Because of the uncertainty, however, participation in clinical research entails some degree of risk. Ethical principles provide the framework on which studies can be designed and conducted and which appropriately balance benefits and risks for research participants. As part of a broad overview of the drug development process, this article reviews the ethical foundations of clinical research.