Human Research Protection Program

Internal Audit of Human Research Protection Program

 

Adopted By: Associate Dean for Research Policy, UW-Madison Graduate School

Adoption Date: December 8, 2005

 

Purpose:  This policy describes the process by which UW-Madison will measure and improve its Human Research Protection Program (HRPP).

Policy and Procedure

I.      Internal Audit of HRPP

A.  The Research Policy Office (RPO) will coordinate periodic internal audits of the HRPP as a means of evaluating compliance with applicable ethical principles, federal, state and local laws, federal guidance and university policies and procedures as well as international standards for human research protection.  The internal audit will include a review of the HRPP’s participant and community outreach and education programs.  The audits will also provide the benchmark for improvements in the HRPP. 

II.     Monitoring of Research

A.  The Research Policy Office (RPO) will coordinate periodic internal audits of selected ongoing research studies to ensure that the studies are being carried out in accordance with the approved protocol, applicable ethical principles, local, state and federal laws and guidance and University policies and procedures as well as international standards on human research protection. 

III.    Monitoring of IRB Review Process

A.  The Research Policy Office (RPO) will coordinate periodic internal audits of the research review process to assess the IRBs and IRB staffs’ compliance with applicable ethical principles, local, state and federal laws and guidance and University policies and procedures as well as international standards on human research protection.