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700-37-For-Cause Audits

Title: For-Cause Audits
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: The IRB Chair or designee (auditor) may perform for-cause audits to evaluate compliance with federal regulations and USU policies and procedures and to verify that project/research activities are conducted in accordance with the IRB-approved protocols.

Purpose: The purpose of this policy is to explain under what circumstances a for-cause audit may occur and how the audit is performed.

Procedures:

  1. The auditor may conduct an audit in response to a particular concern. Concerns which may prompt a for-cause audit include, but are not limited to, the following:
    1. complaints or concerns made by a project/research participant, family member of the participant, project/research team member, or an employee of the University or a collaborating entity
    2. reports of audits or monitoring conducted by other committees affiliated with the HRPP, federal agencies, or other agencies involved in the conduct of a study
    3. issues of non-compliance  (see 700-33: Non-Compliance and Research Misconduct)
  2. The auditor contacts the investigator (or chair if the investigator is a doctoral student), establishes a date for the audit to take place, and requests documents necessary for the audit. The investigator must make such documents available at the time of the audit. Any other materials the IRB Chair deems necessary to accurately understand the project/research process under investigation shall be made available by the investigator upon request.
  3. Using the IRB Audit Checklist, the auditor reviews some or all aspects of the project/research records. This checklist becomes part of the final written report.
    1. No action is taken if the audit does not identify any problems.
    2. 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 700-33: Non-Compliance and Research Misconduct. The IRB may request additional corrective actions as per this policy.
    3. If the audit identifies a problem that might be an unanticipated problem involving risks to participants, or others the IRB follows 700-31: Unanticipated Problems Involving Risks to Participants or Others. The IRB may request additional corrective actions as per this policy.
    4. If the audit identifies problems or deficiencies not covered above, the auditor includes appropriate corrective actions in the written report. The investigator is expected to respond or comply with the corrective actions in a time frame determined by the auditor.
      1. The auditor is responsible for reviewing these corrective actions and following up with the investigator (and chair if the investigator is a doctoral student) to ensure these corrective actions are completed. The auditor 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.
      2. If the corrective actions are not completed, the auditor may recommend to the convened IRB that a suspension be considered for the study that was audited or for the studies that an Investigator is conducting, according to the procedures in 700-34: Administrative Hold, Suspension, and Termination of Research.

4. After an audit, the investigator (and chair if the investigator is a doctoral student) is informed of the result of the review in a report sent via email from the IRB Chair or designee. The report is also sent to relevant Institutional Officials (e.g., Provost, Supervisor, Dean, etc.) as appropriate and stored in the IRB Google Drive.

Scope: This policy applies to projects/research that are audited by the IRB.

Documents and Forms:

IRB Audit Checklist (available on IRB Google Drive)