title: How are drugs approved? Part 2: ethical foundations of clinical research.
abstract: 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.
authors.affiliation: University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pennsylvania 15213, USA. HowlandRH@upmc.edu
authors.forename: Robert H
authors.initials: RH
authors.lastname: Howland
mesh_terms: D026683:Advisory Committees / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000941:ethics; D017277:Drug Approval / Q000458:organization & administration; D028744:Ethics Committees, Research / Q000458:organization & administration; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000941:ethics; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D024802:Nurse's Role; D010344:Patient Advocacy / Q000941:ethics; D028662:Principle-Based Ethics; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D017751:Safety Management / Q000941:ethics; D014481:United States; D014486:United States Food and Drug Administration / Q000941:ethics / Q000458:organization & administration