Internal Audits FAQ
Why are you doing an audit?
Federal Regulations and the Accreditation Agency for Human Subject Research requires that audits be done to verify that the protocols are being followed and that the research is being performed as described to the IRB when it reviews the protocol. The auditors will review Research Protocols and the Human Subjects Research Review Records. In turn, site visits from federal and accreditation agencies will check that the audits are being performed..
Who does the audit?
In this case, an independent contractor will perform the audits. This contractor is not reimbursed by the IRB, but by the institution.
Who decides what projects will be audited?
The independent contractor will determine what projects will be audited, with limited input by the Chairperson of the IRB (HSRRC). Criteria for the projects chosen will be determined by the number of projects from different areas of the university, the different populations covered by the protocols, and will try to include a range of topics. All categories of protocols will be included.
How is the audit conducted?
The independent contractor will be in touch with the PIs of the projects selected to make an appointment to visit the research site. The records of the project will be looked at for completeness and thoroughness; the physical location of the research, if appropriate, will be reviewed; and there may be questions for the PI to answer. It will not be necessary to see the research in progress. The IRB records relating to that project will also be reviewed for completeness.
Who receives the results of the audit?
The Project Director/PI will receive a copy of the findings of the audit. The findings will also be sent to the Institutional Authority and the IRB.