Quality Assurance and Quality Improvement for the Human Research Protection Program- PRO134   

Procedure

OIRB Responsibilities

The OIRB Staff:

• Implements a Continuous Process Improvement culture that ensures that all activities necessary to design, develop and implement the HRPP review processes are effective and efficient with respect to the system and its performance.
•  Continuous Process Improvement can be considered to have three main components:
  • Quality control;
  • Quality assurance; and
  • Quality improvement. 
• The staff will identify an area for potential improvement, acquire data from existing sources or collect new data, test and incorporate changes based on data analysis and reevaluate to see if changes improved the process.

Each OIRB Staff Member:

• Submits suggestions for process improvements and engages in quality improvement projects and initiatives. Suggestions may also come from a variety of sources, for example, IRB members, researchers, coordinators;
• Discusses processes for improvement at management team meetings and OIRB regularly scheduled staff meetings.
• Receives results of the suggestions and implements potential improvement processes.
• OIRB management staff (or delegate) disseminates outcomes and changes implemented by the OIRB/IRB with the IRB Chair, OIRB Director, and affected units/groups for permanent adoption of proposed change(s);

Process Improvement Team Responsibilities

• Process improvement teams are formed based on the processes selected. Teams may include OIRB staff, researchers, IRB members, Research Administration representatives, and representatives from other groups on campus.
• Process improvement teams may have a discrete project to complete or may be a standing team to continuously evaluate or maintain a process.
• Any OIRB staff members act as a process improvement team leader;
• Reevaluate the final results of implementation of changes to determine if overall improvement in the process was achieved.

IRB Member Responsibilities

• Participate in process improvement teams, when their input is necessary, to work with OIRB staff to evaluate changes that directly affect IRB processes and/or their review of protocols;
• Review and approve changes to IRB processes that will directly affect IRB members based on results of the evaluation.

Research Community Responsibilities

• Submit suggestions for process improvements by using the feedback form posted on the UAB IRB website.

Institutional Responsibilities

• Receives results of process improvement projects from the Chair and OIRB Director on a regular basis. Results will also be considered during the annual evaluation of OIRB resources and development of the future needs of the Human Research Protection Program.
• Assists OIRB in obtaining needed resources to evaluate and implement proposed changes to OIRB processes.