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HRPP Policy - Auditing
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
Quality Improvement Office (QIO)
This policy applies to human subjects research under the oversight of the Indiana University Institutional Review Boards (IRBs) and human subjects research for which IU or its affiliates are relying on an external IRB for oversight.Back to top
Research personnel are expected to fully cooperate with all audits, monitoring visits, and compliance inspections (audits) conducted by IU's QIO (internal audits) or regulatory agencies, funding agencies, or study sponsors (external audits), including taking appropriate steps to make necessary improvements to align their conduct of research with applicable federal regulations, state laws, and institutional policies.
QIO staff conduct not-for-cause (scheduled) and for-cause (directed) internal audits of research studies. QIO develops an audit plan that describes the criteria for selecting and prioritizing research protocols and/or PIs for not-for-cause audits. The audit plan is reviewed and approved by the University Director, HRPP on a semiannual basis. For-cause (directed) audits may be requested by the IRB or appropriate institutional officials.
Research personnel must immediately notify QIO upon notification of an external audit. QIO staff serve as a liaison designated by the institution to serve as a resource to the PI, study team, and institution to monitor the progress of the audit and to coordinate key aspects of any written response to the inspecting agency. Research personnel shall immediately provide to QIO all audit-related correspondence and communications to and from the inspecting agency. Research personnel must respond to both FDA Form 483 and Warning Letter correspondence within 15 business days of receipt; for other FDA correspondence (e.g., Untitled Letters), research personnel must seek guidance from QIO regarding whether a response should be prepared. QIO must review responses prior to their submission to the FDA.
Findings from audits must be reported to and reviewed by the IRB in accordance with the IU HRPP Policy on Reportable Events.
For internal audits, QIO staff tracks audit findings and prepares periodic summary reports which are presented to the University Director, HRPP. Reports describe general audit finding trends, any serious or continuing noncompliance, and any unanticipated problems involving risks to subjects or others determinations made in relation to the audit findings.
When an audit report is received, research personnel are expected to respond to all requests. The response should include an action plan to correct any problems identified and an action plan to prevent recurrences, as applicable. Some findings may require additional information, including an explanation of the circumstances that identifies the suspected root cause, the individual(s) responsible for corrective and preventive actions, and a timeline for their completion.
If the study team fails to respond, the department chair may be contacted for assistance. QIO staff may involve an appropriate IRB or other applicable authority for additional assistance at any time.
For internal audits, research personnel must respond within fourteen (14) days unless an extension is granted by QIO staff. The final report is submitted to the IRB via KC IRB.
For-cause audits involving the VA are conducted in cooperation with the local VA research office. Audit findings are promptly shared with the local VA Research Office for audits that include VA subjects.
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
- AAHRPP Standards
- Standard I-5, Elements I.5.A, I.5.B
- Standard I-9
- Element II.2.F
- FDA Information Sheet Guidance for IRBs, Clinical Inspectors, and Sponsors: FDA Inspections of Clinical Investigators (June 2010)
- FDA Compliance Program Guidance Manual, Program 7348.811 - Biomedical Research Monitoring, Clinical Investigators (July 22, 2020)
- Memorandum of Understanding Between Richard L. Roudebush Veterans Affairs Medical Center and Indiana University Concerning Utilization of Indiana University's Institutional Review Boards
audit, continuing noncompliance, corrective action, for-cause (directed) audit, human subject, institutional review board (IRB), internal audit, noncompliance, not-for-cause (scheduled) audit, preventive action, principal investigator, regulatory agencies, research, research personnel, serious noncompliance, sponsor, unanticipated problem involving risks to subjects or others (UPIRTSO)
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