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

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

Abstract:
This procedure outlines the responsibilities of the OIRB, CQIP Team, IRB Member, Research Community and the Institution for quality assurance and quality improvement for the Human Research Protection Program.
Effective Date:
12/10/2008
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO134
Effective Date:   3/30/07
Revision Date:  12/10/08
Subject:  Procedure for Quality Assurance and Quality Improvement for the Human Research Protection Program

PROCEDURE

OIRB Responsibilities

The OIRB Staff:

  • Implements a Continuous Quality Improvement Process (CQIP) 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.
  • CQIP can be considered to have three main components:
    • Quality control;
    • Quality assurance;
    • Quality improvement.
  • The CQIP 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. A CQIP feedback form is posted to the IRB website and will be available for OIRB staff members who wish to submit suggestions anonymously. Suggestions may also come from a variety of sources, for example, IRB members, researchers, coordinators;
  • Discusses CQIP processes for improvement at senior staff meetings and OIRB regularly scheduled staff meetings.
  • Receives results of the suggestions and implements potential improvement processes.
  • OIRB senior staff 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);

CQIP Team Responsibilities

  • 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.
  • The OIRB staff members are lead by a 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 CQIP teams 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 CQIP feedback form posted on the UAB IRB website.

Institutional Responsibilities

Results of CQIP projects will be shared with the Institutional Official by the Chair and OIRB Director at the regular biweekly meeting and 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.

Approved on December 10, 2008, by:

Richard Marchase, PhD
Vice President of Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director