Quality Assurance and Auditing
PURPOSE
Quality assurance auditing at Case Western Reserve University compares the
implementation of the human subjects protocol by the investigator to the specifics
of the
CWRU Institutional Review Board (IRB)
approved protocol. In effect, this confidential process ensures compliance with the
Title 45
Code Federal Regulations Part 46 and
University Policy on the Involvement of Human Participants in Research regulating
human subject research. Specifically, 45 CFR 46 states that "research covered by
this policy be subject to further appropriate review."
The University's FWA also requires that the
Office of Research Compliance
(formerly the Office of Research Administration) and the IRB Administrative Offices
be responsible for procedural and record-keeping audits not less than once every
year for the purpose of detecting, correcting, and reporting (as required)
administrative and/or material breaches in uniformly protecting the rights and
welfare of human subjects as required at least by the regulations and as may
otherwise be additionally required by the FWA institution."
PROTOCOLS SUBJECT TO AUDIT
Any
human subject research protocol approved by the Case Western Reserve University
IRB may be selected randomly for quality assurance auditing or audited on a
for cause basis.
POLICIES AND PROCEDURES
Title 45 Code
Federal Regulations Part 46
University Policy
on the Involvement of Human Participants in Research
CONTACT
Kimberly Volarcik
HRPP Quality Improvement Program Director
216-368-0134
kav6@case.edu
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