Internal processes to evaluate systems in place for the protection of human subjects at the University of Michigan have highlighted target areas for development and improvement. Two such areas are outlined in this proposal. These two areas are of particular importance since, once fully designed and implemented they serve as the major areas the institution has identified to greatly enhance human subject protection. These two programs consist of the Program for the Education and Evaluation of Responsible Research and Scholarship (PEERRS) and the Internal Monitoring Unit of the Center for the Advancement of Clinical Research (CACR-IMU). The PEERRS Program is a web-based foundational training and certification program for faculty, staff and students engaged in research at our institution. This proposal would enhance this program by:
Aim 1 : building a more comprehensive human subjects component of the PEERRS Aim 2: adding specialty modules in areas such as international research, vulnerable populations and IRB member training. The CACR Internal Monitoring Unit will develop a program for interactive project specific education and quality assurance. Once developed this program will regularly monitor all active clinical research protocols at the institution. This monitoring process will be focused on protecting subject safety, ensuring compliance with all regulations applicable to clinical research, and optimizing the validity and integrity of clinical research data.
The specific aims of this proposal are to establish this program by:
Aim 1 : developing guidelines and SOPs for the internal monitoring program for clinical research conducted at the University of Michigan Aim 2: consulting with OHRP, FDA and other pertinent agencies to determine what internal monitoring findings can be handled by corrective actions within the institution and what threshold or types of findings would need to be externally reported.
