Compliance Monitoring and Quality Improvement
This policy describes the process by which UW-Madison will assess and improve its Human Research Protection Program (HRPP).
- UW-Madison monitors the Quality, Efficiency and Effectiveness of the HRPP.
- UW-Madison utilizes the following methods to evaluate the HRPP.
- Several units of the HRPP monitor and ensure individual research projects are being carried out in accordance with the approved protocol, applicable ethical principles, local, state, federal, national/international rules, regulations, guidance and standards, and University policies and procedures.
- The Data and Safety Monitoring System of the Carbone Cancer Center (CCC) ensures that clinical research conducted under the aegis of the CCC is compliant with federal, UW and CCC policies, procedures and requirements by performing: internal audits; quality assurance reviews, response reviews; protocol summary reports; and database monitoring.
- The Institute for Clinical and Translational Research (ICTR) Study Monitoring Service Program serves as the independent Study Monitor of Record for those investigators requiring or desiring such oversight and conducts directed or for-cause reviews as requested by the ICTR Data Monitoring Committee, Health Sciences IRBs or other appropriate entities/agencies.
- The Office of Research Compliance Post-Approval Monitoring (PAM) Program conducts directed and routine reviews across campus for studies that are not subject to review by one of the above HRPP units.
- The PAM program also assists the above HRPP units with their compliance efforts when requested.
- IRB function is monitored through a variety of mechanisms, including regular review of performance metrics, assessment of compliance with applicable policies and regulations, and other quality assurance efforts. IRB monitoring is performed by Office Research Compliance (ORC), the IRB offices, and Deputy Institutional Officials.
- ORC staff conduct regular reviews of IRB compliance with (e.g., regulatory documentation) applicable local, state and federal laws and regulations.
- ORC staff attend IRB meetings to monitor consistency and compliance across UW IRBs.
- Representatives from Office of Legal Affairs also attend IRB meetings to monitor consistency and compliance across UW IRBs.
- The Deputy Institutional Officials conduct ongoing assessments of IRB metrics.
- The IRB Offices conduct internal QA activities as well, which generally include:
- Reviews of IRB staff and member performance.
- Evaluations to produce annual reports regarding IRB function and changes to IRB staff and process.
- Surveys of IRB users to obtain feedback.
- Several units of the HRPP, including the University of Wisconsin Hospital and Clinics (UWHC) and Clinical Research Unit (CRU), monitor outreach to study participants and the broader community.
- UW-Madison regularly evaluates the quality, efficiency and effectiveness of the HRPP, including outreach, educational activities, research project compliance and IRB review processes.
- HRPP assessments are accomplished through a cross-campus two committee structure that facilitates the centralized tracking and review of ongoing compliance, outreach, and educational activities along with process improvement initiatives.
- The Quality and Compliance Operations Committee (QCOC) includes major cross campus HRPP constituents involved with day-to-day compliance, outreach, and education activities.
- The QCOC meets approximately monthly to identify emerging compliance, outreach, and education issues and produce the Quality, Efficiency, and Effectiveness (QEE) Report for the HRPP at least yearly.
- The QEE Report recommends process improvements along with summarizing, aggregating and reflecting the above ongoing compliance and outreach activities
- The Quality and Compliance Oversight and Advisory Committee (QCOAC) is chaired by the Institutional Official for the protection of human subjects and include those in leadership positions across the campus-wide HRPP.
- The QCOAC reviews the QEE Reports that are produced by the QCOC to identify institutional priorities, deficiencies, improvements, and determine appropriate resource allocation.
Adopted By: Associate Dean for Research Policy, UW-Madison Graduate School
Adoption Date: November 3, 2011
Revised By: Cross-Campus HRPP Committee
Effective Date of Revision: August 28, 2015
Effective Date of Revision: April 7, 2016