Internal Audits

Quick guide: Internal audits of human subjects research

IU’s Office of Research Compliance conducts research compliance audits that are internal to the University. Audits are conducted in accordance with the IU Standard Operating Procedures for Auditing Human Subjects Research and are categorized as either for-cause (directed) or not-for-cause (scheduled).

Words to know

  • For-cause (directed): Audits requested by an IRB, IRB chair, the director of the Human Research Protection Programs, or the associate vice president of research compliance when circumstances require an on-site record review, generally related to reported or suspected noncompliance.
  • Not-for-cause (scheduled): Audits that are part of the IU Human Subjects Research Audit Plan and Schedule. Criteria used to select studies for a not-for-cause audit vary and are approved by the IU IRB Executive Committee semi-annually. Examples of criteria include but are not limited to the following factors:
    • Clinical studies opened by a new principal investigator (PI) or an existing clinical study that has been transferred to a new PI.
    • The PI holds the Investigational New Drug (IND) or Investigational Device Exemption (IDE).
    • Factors indicating study subjects may be at increased risk (i.e. PIs with a high volume of studies, studies with minimal or no external oversight, inclusion of vulnerable populations, past or present subject safety or noncompliance issues, involvement of investigational drugs or devices).

Investigators may request to be on the schedule for a not-for-cause audit to ensure continuing compliance in their research studies by contacting IU’s Quality Improvement Office. Participating in a scheduled audit can provide valuable education for all research staff as well as principal investigators. QIO staff members make every effort to include these requested audits on the schedule, based on current workload and risk assessment.

How it works

Who to contact

Contact the Quality Improvement Office within the Office of Research Compliance at researchcompliance@iu.edu.