Click HERE for a Sample Response Letter.
The mission of the IRB Office Auditing and Compliance (A&C) program is to improve the quality of the human research subject's protections program and increase awareness of regulatory compliance. Our role is to measure compliance with federal regulations and institutional policies, and identify potential areas of improvement.
The Auditing and Compliance program will evaluate the various components of the human
subject protection program including IRB office staff functions and the implementation
of IRB policies and procedures to include documentation such as meeting minutes, study
files, or review guides, including the evaluation of corrective action plans. The
existing structure, policies and procedures will be evaluated and when deficiencies
or opportunity for improvement are perceived, corrective action or revisions to policy
and procedures will be recommended. The A&C program will also strive to provide services
to the research community that include directed self-assessments, educational opportunities,
not-for-cause evaluation of study files and investigator SOPs, and pre-audit preparation
(for outside auditing situations).
The A&C program may also evaluate the human subjects protection programs in other ways, such as conducting not-for-cause consent monitoring and auditing.
The IRB Office auditors began Quality Systems Compliance Assessments in July 2012. Please review the PowerPoint presentation to learn more about the new assessment plan and how it will impact you as a researcher.
If you have any questions, or need assistance, please contact the IRB Office at 706-721-3110.