The Ethical Problems of the Open Label Extension Study

Abstract

The institutional review board (IRB) Is charged with assessing the risks and benefits of research projects Involving human subjects. Ethical considerations and federal regulations require that an IRB, in part, must find that the potential risks of participation are proportional to the potential benefits (If any) and to the Importance of the knowledge that may be learned before the IRB can approve the voluntary assumption of risk by a research participant. Adequate assessment of the risks and benefits requires careful scrutiny of the study design In relation to the study objectives.