Quality Improvement Program

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 pursue quality improvement through a self-assessment evaluation. The below checklists systematically evaluate various components of the research study, according to federal regulations, HRPP policy, OHRP guidance, and Good Clinical Practice. The HRPP Office recommends study teams review their processes and the status of their studies regularly to identify strengths, weaknesses, and education opportunities. 

Please contact the HRPP Office to request a routine evaluation or to consult with the HRPP QI Program as a follow-up to completion of a self-assessment form.

Click here to access the Regulatory Binder Evaluation Form.

Click here to access the Self Assessment Evaluation Form.

OUHSC Contact

865 Research Parkway, Suite 400
Oklahoma City, OK 73104

ph: (405) 271-2045
fax: (405) 271-1677

Email Us: irb@ouhsc.edu

Norman Contact

Five Partners Place
201 Stephenson Parkway, Suite 4200
Norman, OK 73019

ph: (405) 325-8110

Email Us: irb@ou.edu