Audit

Updated version September 29, 2023

Applicability 

Overview 

COUHES has the responsibility and authority to ensure that investigators conduct research activities in accordance with the terms of their IRB approval. As such, COUHES conducts reviews and inquiries regarding research activities as needed to obtain information necessary for the fulfillment of its responsibilities under the MIT Assurance to OHRP, OHRP, and FDA. This includes monitoring and auditing all research conducted in which MIT is engaged. 

Directed investigations and routine audits may be conducted to monitor research activities to determine that the rights, safety, and well-being of research subjects have been properly protected as well as to assess adherence to the approved protocol along with applicable rules and regulations. As part of its monitoring, COUHES may evaluate subject recruitment methodology, the informed consent process, protocol adherence, data security practice, safety monitoring and reporting, facilities available in an emergency, and other related processes. 

Criteria 

The criteria for selecting studies to be reviewed may include: 

  • Evidence suggesting noncompliance or research misconduct. 
  • Complaint(s) about protocol or subject’s rights, safety and welfare violations. 
  • Concerns initiated by institutional officials regarding compliance, protocol adherence, or subject safety. 
  • Studies that involve greater than minimal risk and are currently enrolling participants. 
  • Studies involving vulnerable populations. 
  • Studies collecting sensitive and identifiable data. 
  • Studies associated with unexpected harm to participants. 
  • Funding source. 
  • Studies involving a large number of subjects and/or fast enrolling. 
  • Investigators with multiple PI-initiated studies. 
  • Studies with high research staff turnover. 
  • A division head or PI may request a preventive on-site review. 
  • Random selection for scheduled audits. 
  • Scheduled audit required at time of approval. 

Types of Audits 

For Cause 

A for-cause, or directed, audit may be requested by COUHES, the COUHES Chairperson, the Vice President for Research, or other appropriate parties. These audits may be requested in relation to allegations of non-compliance. In cases of allegations of non-compliance, the directed audit will be completed in accordance with COUHES SOP for Managing Cases of Non-Compliance. 

Not for Cause 

A not-for-cause, or scheduled, audit is carried out as part of COUHES’ review and monitoring of post-approval research activities. An approximately 3-5% sampling of active non-exempt protocols may be taken to determine the appropriate number of scheduled audits to conduct. Studies may be selected randomly, or with input from COUHES staff, the Chairperson, or other appropriate parties. Efforts will be made to ensure studies from a diverse number of Principal Investigators, departments, and/or research topics are selected. Principal Investigators may also request to be scheduled for a not-for-cause audit to ensure continuing compliance in their research studies by contacting COUHES directly. 

The COUHES Office and audit team determines the scope of audit, mechanism of review, and materials to be reviewed. Depending on the scope of the audit, the audit may be conducted: 

  1. On site
    • On site audits may be conducted on studies determined to be greater than minimal risk, involving vulnerable populations, collecting sensitive and identifiable information, or other circumstances relating to the rights and welfare of subjects. 
    • May include a review of study records, observations of research processes such as the informed consent process or study interventions/interactions, and/or interviews with research personnel. 
    • May occur over multiple sessions and/or multiple days. An exit interview may be occur at the end of the audit. 
  1. Remote
    • Remote audits may be conducted on studies determined to be minimal risk research. 
    • May include a self-assessment completed by the PI and reviewed by the audit team, a review of study records, and/or interviews with research personnel. 
    • A summary of audit findings may be provided to the PI via email following audit completion in lieu of an exit interview. 

Audit Outcomes

The audit team will prepare an inspection observation report and submit to COUHES. The COUHES Chair and if necessary the COUHES committee will review the findings, after which the PI and other applicable parties, as appropriate, will be notified in writing of the final results and any corrective actions that may be required. 

The decision of COUHES on what is appropriate corrective action is final and is not subject to appeal. Where appropriate, copies of the corrective action required by COUHES will be forwarded to key stakeholders, including the Vice-President for Research, Office of the Provost and the relevant Deans and Department, Center, and Laboratory Heads. 

Reporting Requirements 

Federally funded research may require notification to the funding agency of findings of non-compliance and notification of termination or suspension. In consultation with COUHES, the Institutional Official (IO) is responsible for incident reporting to federal agencies. For research involving collaborative institutions, COUHES will notify collaborating sites. 

COUHES will maintain records related to the investigation for a minimum of 3 years once the written notice of determination has been issued.