It is UAB policy to conduct compliance activities related to research activities. The Office of the IRB (OIRB) is responsible for implementation of quality assurance and quality improvement programs related to the Human Research Protection Program. The OIRB shall establish a regulatory monitoring plan as well as quality assurance and quality improvement activities. The quality assurance activities will be designed to monitor compliance with federal and relevant state laws and regulations, UAB policies and procedures, and IRB requirements related to the Human Research Protection Program. Quality assurance activities will include reviews of research activity (both systematic and as directed by the IRB or Institutional Official) and reviews of IRB and OIRB activities. Review of IRB and OIRB activities will be performed in conjunction with the Office of the Vice President for Research and Economic Development. All monitoring reviews will be conducted in accordance with a monitoring plan. (See also PRO134 Procedure for Quality Assurance and Quality Improvement for the Human Research Protection Program; PRO102 Procedure for Quality Assurance (Monitoring of Human Subjects Research).)
The IRB will receive results of any monitoring review which it directs and any other review which suggests evidence of serious or continuing non-compliance with regulations or policies and procedures related to the Human Research Protection Program, unanticipated problems involving risks to human subjects or others, unexpected serious harm to subjects, or research not conducted in accordance with IRB determinations or requirements. Quality assurance reports listing each review, its findings, and any recommendations and actions will be reported to the Institutional Official's office quarterly.
The quality improvement activities will be designed to achieve and maintain compliance and achieve targeted levels of quality, efficiency, and effectiveness of the Human Research Protection Program. The objectives of the quality improvement activities will be based on the quality improvement activities and measures of effectiveness pertaining to the Human Research Protection Program through planning improvements, enacting the planned improvements, and measuring the effectiveness of the changes. Quality improvement projects may arise through root-cause analysis of problems discovered from quality assurance reviews, systematic examination of Human Research Protection Program processes, or in response to reports of concerns or constructive criticisms or suggestions for improvement regarding the Human Research Protection Program.
Approved on March 6, 2016, by:
Ferdinand Urthaler, MDIRB Chair
Jonathan Miller, MPPA, CIPOIRB Director