Enhancing Human Subjects Research Protection

University Of North Carolina Chapel Hill, Chapel Hill NC

Investigators

Abstract

The University seeks funding to undertake three interrelated projects designed to strengthen the program of human research subject protection at the University of North Carolina at Chapel Hill. The first project will involve process improvement for the IRBs, based on development of Standard Operating Procedures and a common computer-based information system to track protocols and handle administrative functions. The second project will improve the informed consent process through intensive training of those who enroll and obtain consent from human subjects themselves. The third project will upgrade the training received by all members of all eight IRBs at the University, with a special emphasis on the recognition, assessment and mitigation of risks and the realistic assessment of potential benefits. Collectively, these projects will significantly enhance human research subject protection at the University.