Continued interim funding under the """"""""Human subjects Research Enhancements Program"""""""" will provide opportunity for Temple University to extend and expand initiatives developed and implemented under the original award. The new award will enable the University to: (a) develop and implement an integrated IRB management system to monitor and track human subjects protocols, linking all data and procedural requirements to compliance; (b) enhance its education, training and certification programs for all key research personnel, IRB members and IRB staff, and (c) update and complete its SOPs, develop an investigator's guide and handbook on human subjects protection and best practices, and initiate a program preparatory to self-assessment and accreditation of its IRB. In addition to, and as part of a protocol management system, we will develop and implement a web-based """"""""informed consent assistant"""""""" to help an investigator construct online their informed consent at the appropriate grade level and incorporating the required elements. We will also implement an adverse events tracking and monitoring system. The latter tools will be acquired from the Office of Regulatory Affairs at the University of Pennsylvania and tailored to our special requirements. Additionally, the University will form a regional Human Subjects Protection Consortium with other institutions that are not funded under the enhancement program for the purpose of sharing resources, exchanging ideas, participating in joint education and training programs, and identifying areas of concern. Five (5) organizations have expressed interest in joining the Consortium; more will be solicited during the award period. Also, the IRB will work closely with the Research Subject Advocate in our GCRC to implement data safety and monitoring plans for all investigator initiated protocols and other studies as needed.
