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Human Subject Research Quality Assurance/Quality Improvement Program

Research involving human subjects is essential for the progress of scientific knowledge.  Washington University has long been committed to maximizing the safety of all volunteers who participate in these important studies.  All proposed human  research is reviewed by the  Institutional Review Board (IRB).  The IRB panels are composed of University and community volunteers who work to ensure ethical treatment of research participants.  Regular progress reports and reports of any unexpected occurrences are required for all approved ongoing studies.

Quality Assurance Activities

As part of the Quality Assurance/Quality Improvement Program, a faculty committee reviews selected ongoing research studies from either  campus  to ensure that the studies are being carried out in accordance with the approved protocol and that the participants had been clearly informed what to expect at the time of their enrollment.  The review also considers adherence to University and regulatory policies for the protection of human subjects.

The review process is an essential element of our accreditation by the Association of Human Research Protection Programs (AAHRPP).  Washington University (WU) and AAHRPP recognize that the commitment to human research participation does not end with the approval of the proposal by the Institutional Review Board.

Quality Improvement Activities

As an outgrowth of the monitoring activities, the analysts and staff work with other compliance offices to develop  education and tool that will  assist in the performance of high quality human research.   Educational offerings  cover the basics of clinical research coordination and WU policies and procedures.  The research resource forms that can be found on the attached link represent input from a group of coordinators  who gathered this document library for use in studies  where no data forms are provided.  The forms are meant to be downloaded and can be revised to suit a particular protocol.

 

Links

Key Elements for Monitoring Adherence to Human Subjects Research Protocols

Stratification of Risk Potential to Human Subjects

 

Frequently Asked Questions

Office of the Vice Chancellor for Research

Human Subject Research Quality Assurance/Quality Improvement Program

660 S. Euclid

Campus Box 8093

St. Louis MO, 63110

Aerial view of the Center for Advanced Medicine