OU Human Research Participant Protection

Quality Improvement (QI) Program

 

 

The Human Research Participant Protection (HRPP) Program at the University of Oklahoma is committed to the improvement of the quality, efficiency, and integrity of our research activities. In pursuit of this commitment, the HRPP and the Institutional Review Board (IRB) support a QI Program to assess the research activities conducted in accordance with the University's Federalwide Assurance with the Office of Human Research Protection (OHRP).

The objective of the QI Program is to ensure that proper scientific, ethical, and regulatory requirements, through proper documentation, record keeping, data analysis, and compliance to all components that constitute good academic research practice, are followed throughout the IRB's approved protocols. The program is designed to continually evaluate, provide education, and improve the research process, ultimately providing a higher degree of safety to our human research participants.

There are four basic components to the QI Program:

  • Routine Evaluations
  • External / For-Cause Evaluations
  • Internal Evaluations
  • Self-Assessment Evaluations.

Routine Evaluations

Monthly, "routine" QI Evaluations of investigative sites will be performed through selection of protocols.
These monthly protocols will be identified at random by performing queries of the IRB database using established criteria (e.g. Investigator initiated studies, federally sponsored studies presenting a moderate to high risk). The purpose of the "routine" evaluation is to determine if the rights and welfare of research participants used in studies have been properly protected in accordance with federal regulations, OU institutional policies, and Oklahoma state laws.

For-Cause Evaluations

The IRB or IRB Executive Committee will recommend "for-cause" evaluations of investigative sites occurring as a result of known or suspected problems in the conduct of human participant research. These "for-cause" evaluations will be performed to ensure the highest degree of research standards are being maintained in regards to the safety of human participant research.

 

 

 

Internal Evaluations

Routine QI evaluations of the IRB operations and records will be conducted through random selection of protocols. The purpose of the Internal Evaluation is to determine the adherence of IRB records to federal regulations, state law, IRB and OU institutional policies governing human research and to provide ongoing assessment of IRB operations for continuous quality improvement.

 

 

 

Self Assessment Evaluations:

Investigators may choose to evaluate their effectiveness and seek quality improvement through their own self-assessment evaluation. This option will allow investigators to determine or identify areas of improvement. The checklist aids investigators to identify areas of improvement by following an algorithmic approach. This model is offered as a resource for Investigators to promote their own quality improvement at their research sites.

 

Click here to access the Self Assessment Evaluation Form.