CHAPTER 5 – Institutional Review Boards

Publisher Summary Research involving human subjects, even if they may benefit directly from participation, is a different kind of enterprise from the routine practice of medicine. In research, physician/researchers' goals include not only the welfare of individual subjects, but also gathering of the scientific data for application in the future. Therefore, our society has granted a conditional privilege to perform research with human subjects; the condition is that the research must be scientifically sound and conducted in a manner that protects the rights and safeguards the welfare of the participants. The current U.S. system for protecting human research subjects, including the role of Institutional Review Boards (IRBs), is undergoing serious evaluation. This chapter focuses on the development of U.S. federal regulations concerning research involving human subjects and the roles and responsibilities of IRBs. The IRB system is well developed but ever evolving. Successful evolution of the system depends on learning from the past, understanding current and future needs, and applying the knowledge to implement meaningful improvements. Researchers, research participants and institutions, and others, particularly the American people, who bear the burdens of research and to whom the benefits accrue, all have a stake in the process.