Quality Improvement (QI) Program

Human research protocols and study sites are selected at random for a routine evaluation. The random selection is made by performing a query of the IRB database using established criteria, such as, for example, investigator-initiated or federally funded studies, or a risk-based approach. 

Conducted by OU HRPP QI staff, the purpose of a routine evaluation is to determine if the study is being conducted as approved by the IRB and in compliance with HRPP policies, other institutional requirements, federal regulations, and Oklahoma state laws. 

For-cause evaluations are conducted by OU HRPP QI staff and can be initiated upon request by the IRB, IRB Executive Committee, HRPP Office, or other University administrative officials, due to significant risks to participants, routine failure of an investigator to comply with federal and/or institutional requirements, allegations or concerns about the conduct of the research, or any case requiring further scrutiny as deemed appropriate by the IRB.

For-cause evaluations, sometimes referred to as "directed" evaluations, are performed to ensure the highest degree of research standards are being maintained in regards to the safety of participants. 

Results of for-cause evaluations are reported to the HRPP Director and to the IRB that requested the evaluation for review and determination of appropriate action(s) if necessary. 

This type of QI evaluation may be voluntarily performed by the PI and/or research staff. However, a PI may also be prompted by direct invitation to perform a self-assessment review as part of the HRPP's routine evaluation initiative, or directed by the IRB. 

The self-assessment checklists include questions pertaining to federal regulations, local IRB policies and procedures, OHRP guidance, and Good Clinical Practice (GCP) and may be completed by the PI and/or research staff. The results of a PI self-assessment may be submitted to QI staff. 

Generally, results of a PI Self-Assessment are not reported to the IRB unless the IRB directed the PI to complete a self-assessment; or the results of voluntary/routine assessments identify significant deficiencies in protecting participants or significant noncompliance with IRB policies and determinations, or federal regulations.

As part of routine and for-cause evaluation initiatives, QI staff may observe the conduct of research activities such as obtaining informed consent from participants, to ensure the process is carried out as approved by the IRB. 

The IRB may request a consent observation when necessary as a result of: 

• non-compliance, harm, or deviation reported in an Incident Report Form;
• information reported at the time of Continuing Review; 
• a participant complaint; or
• any other situation the IRB deems appropriate when additional protections are necessary. 

Routine evaluations of  IRB operations will be conducted to assess IRB records, including submissions processed, actions of the convened IRB, IRB Chair or IRB designee, membership rosters, and meeting minutes. The purpose of internal evaluation is to determine the adherence of IRB records to federal regulations, state law, IRB and OU institutional policies.

Other routine evaluations include assessing HRPP/IRB policies to ensure compliance with applicable federal and state law/regulations and University policy. 

Improvements to the HRPP and IRBs shall be implemented based upon findings from routine internal evaluations, including education and training, revising policies, and making necessary changes to procedures.