Abstract
The conduct of clinical trials is a complicated process involving a myriad of regulations and enforcement entities. To protect the rights and welfare of study participants, a system of oversight bodies called institutional review boards has been established in the US. This article describes how institutional review boards work and explains what clinical researchers need to know about federally mandated human subject protection requirements.
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References
1.Code of Federal Regulations Title 45 Part 46 “Protection of Human Subjects” Revised June 23 , 2005 .