Ethical Considerations in Clinical Trials: An International Perspective

Abstract

Ethical conduct of biomedical research involving human subjects is one of the critical elements for a successful outcome of a clinical trial. Many national and international guidelines and regulations have been established to address the ethical conduct of clinical trials. This paper will describe the roles and functions of the institutional review board and the involvement of the Office for Protection from Research Risks and the Food and Drug Administration in protecting human subjects involved in clinical trials in the United States. It will highlight the international ethical principles and guidelines. Comparison of the international ethical guidelines with United States regulations will also be provided, with emphasis on ethical review and informed consent.