Frequently Asked Questions

 

Q:  How do you determine who to audit?

 

A:  Routine audits are of those studies that are selected for audit by pre-determined criteria based on assessment of regulatory risk. Some examples of those criteria are funding source, number or type of studies being done by any one investigator, and studies involving vulnerable populations.  Directed Audits are those that are requested to be done by an internal or external committee or individual.

 

Q:  Where do you send audit reports?

 

A:  A final audit report is issued to the PI, with a copy to the Chair of the PI’s department. Five working days after issuing to the PI, the report, and any response received, is forwarded to the Human Subjects Research Office, with a copy to the Vice Provost for Research.

 

Q:  Do you work for the IRB?

 

A:  No. The Office of Research Compliance Assessment is under the purview of the Vice Provost for Research. The IRB may make a request to the Vice Provost for Research for the RCA to conduct a directed audit, but the RCA is separate and distinct from the IRB.

 

Q:  How do I submit a response to an audit report?

 

A: You have five working days in which to review and respond to a report, after which both the report and your response will be forwarded to the Human Subjects Research Office (HSRO).   Please submit your response directly to the RCA auditor, preferably electronically.

 

Q:  What if I can't respond to the audit report within five working days?

 

A: If a response is not received within five working days from the time the report is issued, the report will be forwarded to the HSRO.  You may then submit your response to the HSRO or they will contact you for follow-up.  If your response to the findings is incomplete and/or unsatisfactory, you will be contacted by the HSRO.

 

Q:  What should I do with the audit report?

 

A: The audit report is an internal document.  There is no need to submit the audit report to the funding agency.