Balancing act: Reducing regulatory burdens without increasing risks

March 2010
Clinical Trials Administrator;Mar2010, Vol. 8 Issue 3, p25
The article focuses on the findings by several research organizations that some measured changes can help in the reduction of investigators' regulatory burden without having higher risks to the subjects in the U.S. A program has reportedly expanded the number of studies that qualify for exemptions and is working on a project to give flexibility to principal investigators (PIs) in the process of making minor modifications. Research officials worked carefully to determine areas that could be changed without affecting the right of human subjects.


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