The University of Texas Medical Branch proposes to establish two distinct but interrelated programs that would significantly enhance human subject protections. The first is an innovative educational effort that will establish a formal Certification Program on human subject protections. The Program has been designed to facilitate and encourage Investigators to participate, but will be open to all research team personnel. There will be five major requirements for completion of the Certification Program and participants will be expected to complete the program within a 12-month period. A unique aspect to this training will be the emphasis on education relevant to ethical issues in human subject protections. The second program is a Clinical Research Monitoring Program that will review and monitor human subject studies as they are being conducted. This Program will include a study risk assessment, will utilize specific policies and procedures established for the review program, and will examine critical study elements such as the informed consent process, informed consent forms, IRB correspondence, data documentation, and management of serious adverse events. Both programs will be activated out of the Office of the Vice President for Research, will be campus-wide, and will be supported beyond the official award period of the grant. Our intent with these Programs is to convey the critical importance for a profound commitment to carefully designed, ethically sound, and appropriately conducted human subject research studies.
