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, which regulate human subject research.
Specifically, 45 CFR 46 states that "research covered by this policy be subject to further appropriate review." The university's Federalwide Assurance (FWA) also requires that the CWRU Human Protection Program 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.