Post Approval Review Program
One purpose of the Post Approval Review Program (PAR) is to provide internal evaluation of research team compliance in research with human participants. The PAR Quality Assurance and Quality Improvement program is an important component of the HRPP that evaluates regulatory compliance associated with the performance of human subjects research conducted at the University or by the researcher partners (Fairview and Gillette).
The PAR program is also intended to provide a mechanism for assuring the quality of human subjects’ research by evaluating the quality, effectiveness, and efficiency of the Human Research Protection Program (HRPP).
Another purpose of the PAR program is to gather and apply internal performance information for the purpose of continuous improvement of the HRPP. The PAR program is in the process of expanding activities to include the monitoring/observation of the informed consent process and enhanced reporting and analytics of PAR findings and metrics.
Research Compliance Reviews
Review of Institutional Review Board-approved studies in response to an identified concern (complaint, information, or event). The IRB evaluates Risk-Based Review reports.
- For-cause review based on the receipt of a complaint
- High-risk research conducted under an investigator initiated Investigational New Drug (IND) application or Investigational Drug Exemption (IDE)
- Review conducted in response to IRB directive or concern
Supplemental Compliance Review
Review of IRB-approved studies to assess investigator and/or IRB compliance. The IRB evaluates Supplemental Compliance reports.
- Review of studies to verify that no unapproved changes have occurred
- Review of studies to verify informed consent practices and compliance
- Review of studies to verify existence of protocol deviations
Investigator self-assessment to evaluate investigator compliance. Self-assessments are study-specific and are most frequently implemented in minimal-risk studies.
- Verification of study funding
- Principal investigator training/qualifications assessment
- Consent process documentation procedures