POLICY STATEMENT

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 and quality improvement subgroup with responsibility to address quality assurance and quality improvement activities. The quality assurance program 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 monitoring 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 Compliance and Risk Assurance. 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.

Quarterly reports are compiled to share the quality assurance program activities with the IRB.

The quality improvement program will be designed to improve existing processes within the Human Research Protection Program. Quality improvement activities will be based on 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.