IRB Human Subject Research Enhancements

Cleveland Clinic Foundation, Cleveland OH

Investigators

Abstract

The Institutional Review Board (IRB) of The Cleveland Clinic Foundation is proposing to enhance and strengthen oversight of human subject research by developing and implementing new educational and training programs involving perspectives from research participants, updating informed consent guidelines, procuring training programs for IRB members, investigators and other research personnel. The other major enhancement for the IRB involves the purchase and implementation of an upgraded IRB database system. Currently all investigators conducting human subject research are required to complete the Collaborative IRBTraining Initiative (University of Miami Course) and ensure that collaborating investigators, study coordinators andother research support personnel involved with enrolling research subjects or performing research procedures are adequately trained and knowledgeable of the study protocol and regulations on human subject protections. This application proposes to enhance the existing resources by developing special educational and training materials that address current and useful information in a format that is easily accessible, quick to review and updateable. The other major component of this application involves identifying and implementing an IRB database program that can it;corporate current technologies for project tracking, reviewing and investigator electronic submission capability. The IRB Executive Director will be responsible for the overall coordination of these activities and will utilize an advisory committee comprised of the IRB Chairman, IRB Vice-Chairmen, Director of Clinical Research, and Associate Director of Professional Staff Affairs to ensure that resources will be appropriately managed to achieve the proposed educational and operational changes requested. Dr. Richard Rudick, Director of Clinical Research will also serve as Co-Principal Investigator.