Institutional Review Board

PURPOSE

The University of Utah Institutional Review Board (IRB) conducts routine and for-cause audits using systematic methods to evaluate compliance with federal regulations, state and local laws, and University of Utah policies and procedures, and to verify that research is conducted in accordance with the IRB-approved protocols.

SCOPE

This policy applies to human subject research conducted at the University of Utah.

POLICY

IRB audits involve review of study documentation to assess regulatory compliance, protocol adherence, and practices at the site level. These audits help monitor, measure, and improve the effectiveness of the IRB or Human Research Protection Program (HRPP). The audit also identifies errors or omissions in study conduct and provides investigators with recommendations for corrective actions and improvements to better protect the rights and welfare of research participants.

In this policy, an IRB designee refers to a person designated in writing by the IRB Chair to assume the role of an ad-hoc auditor. The IRB may also accept audits conducted by the Research Compliance Officer at the VA.

PROCEDURES

1. Procedures for Initiating an IRB Audit
   1. For a routine audit, the IRB administrator or designee selects an investigator or study for a routine audit based on criteria which includes, but is not limited to, the following:
      • Studies involving procedures that are greater than minimal risk to subjects
      • Studies involving vulnerable populations
      • Investigator-Initiated drug/device studies
      • Investigators overseeing or conducting a high volume of active studies
      • Studies approved using expedited procedures that are not subject to continuing review
   2. For a for-cause audit, the convened IRB, IRB Chair, Subcommittee, or IRB Director may direct the IRB administrator or their designee to conduct an audit in response to a specific concern. These audits are initiated to ensure the rights and welfare of research participants are protected and may be prompted by concerns including, but not limited to, the following:
      • Complaints or concerns made by a research participant, family member of the research participant, research team member, or an employee of the University or the covered entity.
      • Reports of audits or monitoring conducted by other committees affiliated with the HRPP, federal agencies, data and safety monitoring committees, or other agencies involved in the conduct of a study.
      • Issues of non-compliance including unanticipated problems, and serious or continuing non-compliance.
   3. The IRB administrator or designee contacts the investigator and establishes a time and place for the audit to take place. All documentation generated as part of the research under audit may be subject to review. The IRB administrator informs the investigator which documents are necessary for the audit. The investigator must make such documents available at the time of the audit. Any other materials the IRB administrator deems necessary to accurately understand the research process under investigation shall be made available by the investigator upon request.
   4. Using IRB auditing tools, the IRB administrator reviews some or all of the aspects of the research records.
2. Procedures for Completing an IRB Audit
   1. After an audit, the investigator is informed of the result of the review in a written report from the IRB administrator or designee. The written report is also sent to the IRB Chair, IRB Director, and other Institutional Officials and other units within the University or the covered entity as appropriate.
   2. If the audit does not identify any problems or deficiencies, no action is taken.
   3. If the audit identifies problems or deficiencies, the IRB administrator includes appropriate corrective actions and/or recommendations for improvement in the written report. The investigator is expected to respond or comply with the corrective actions in a time frame determined by the IRB administrator. The IRB administrator is responsible for reviewing these corrective actions and follows up with the investigator to ensure these corrective actions are completed. The IRB administrator may accept confirmation of completion for the corrective actions through a statement from the investigator, other documentation from the investigator, or a follow-up audit.
   4. If the audit identifies problems or deficiencies that cannot be resolved through corrective actions or if the corrective actions are not completed, the IRB administrator may recommend to the convened IRB that a suspension be considered. This may apply to the audited study or to other studies being conducted by the investigator, in accordance with IRB SOP 904: Administrative Hold, Suspension and Termination of Approved Research.
   5. If the audit identifies non-compliance, such as lack of oversight, deliberate falsification or omission, failure to comply with the requirements and determinations of the IRB, significant protocol violations, or deviations or frequent occurrences of such, the IRB follows IRB SOP 903: Human Research Protection Program and Non-Compliance. The IRB may request additional corrective actions as per this policy.
   6. If the audit identifies a problem that might be an unanticipated problem involving risks to participants or others the IRB follows IRB SOP 901: Unanticipated Problems Involving Risks to Participants or Others. The IRB may request additional corrective actions as per this policy.