Human Research Participant Protection Quality Improvement Program
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 Quality
Improvement (QI) Program to assess the research activities
conducted in accordance with the University's Federalwide Assurance
with the Office of Human Research Protection (OHRP).
objective of the Quality Improvement (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.
are four basic components to the QI Program: Routine Evaluations, External Evaluations ("for cause"), Internal Evaluations,
and Self-Assessment Evaluations.
"routine" Quality Improvement 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.
Institutional Review Board (IRB) or IRB Chair 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.
QI evaluations of the Institutional Review Board
(IRB) operations and records will be conducted through random selection
of protocols identified. The purpose of the Internal Evaluation is to determine
the adherence of IRB records to federal regulations, state law,
IRB and institutional policies governing human research and to provide
ongoing assessment of IRB operations for continuous quality improvement.
Assessment Evaluations (Click for link):
may also 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.
Investigators may obtain the "self-assessment evaluation" checklist
from the HRPP website. 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.