Human Research Quality Assurance/Quality Improvement Program Roles and Responsibilities

Unit Role
Education and Awareness
Monitoring
Noncompliance
Coordination Among Entities
Records and Reporting

Unit Role

Washington University’s Human Research Quality Assurance/Quality Improvement Office (HR QA/QI) performs on-site monitoring of open human subject research protocols to help assure compliance with Federal regulations and University and sponsoring agency policies and procedures governing human research. The HR QA/QI Office supports the HR QA/QI Committee, which oversees all HR QA/QI monitoring activities and assesses findings. The HR QA/QI Program helps to assure that the rights and welfare of human research participants are protected and that the performance of research involving human participants at Washington University meets the highest standards of quality.

The HR QA/QI Office reports to the Associate Vice Chancellor for Research Administration

Education and Awareness

  • Disseminates information and provides guidance regarding compliance with Federal regulations and University and sponsoring agency policies and procedures.
  • Coordinates with the Human Research Protection Office (HRPO) and the Center for Clinical Studies (CCS) to develop and implement educational programs and tools to effectively train researchers and staff participating in human research and related activities.
  • Recommends education and process enhancements that will raise performance standards related to the conduct of research involving humans.

Monitoring

  • Selects open human research protocols for monitoring based on risk assessment.
  • Monitors open human research protocols and related activities to assure that human research is conducted and administered in accordance with Federal regulations, University and sponsoring agency policies and procedures, and protocols approved by Human Research Protection Office (HRPO) Committees.
  • Reviews informed consent procedure to assure that research participants are informed appropriately and in accordance with with Federal regulations and University and sponsoring agency policies and procedures.
  • Reviews on-site record keeping to verify adherence to Federal regulations and University and sponsoring agency policies and procedures.

Noncompliance

  • Supports and endorses cooperation with University compliance efforts and reports instances of noncompliance to the appropriate compliance office.

Coordination Among Entities

  • Works closely with HRPO and CCS throughout monitoring of open human research protocols to help facilitate cooperation and assure compliance with Federal regulations and University and sponsoring agency policies and procedures governing the use of human research participants.
  • Coordinates with the Vice Chancellor for Research to identify appropriate corrective actions for human participant research that is not being conducted in accordance with HRPO requirements, Federal regulations, and University and sponsoring agency policies and procedures.
  • Coordinates with Principal Investigator and department administrator to implement corrective actions.

Records and Reporting

  • Reviews evidence of noncompliance identified during monitoring and reports findings to institutional officials and oversight entities in accordance with Federal regulations and University and sponsoring agency policies and procedures.