Post-IRB Approval Reviews

The Quality Assurance program conducts post-IRB approval reviews or audits to enhance the protection of human subjects and verify that IRB approved procedures are being followed. Any study determined exempt or approved by the IRB may be selected for a post-IRB approval review.  Post-IRB approval reviews should not be viewed as punitive.  They are an opportunity for the study team and investigators to ensure that they are adequately following their IRB approved protocols and to determine if any improvements or modifications are needed for their outlined study procedures.  The Quality Assurance team tries to provide constructive, helpful feedback on study procedures to facilitate a smoother IRB submission process for the study team in the future and to educate on IRB rules and requirements.  The goal of Quality Assurance team is to select a wide scope of studies to review so that investigators have a better understanding of IRB requirements and may be prepared for outside audits from funding agencies or other regulatory bodies. 

Although not punitive in nature, failure to cooperate in the post-IRB approval review process for either onsite reviews or self-assessments is a violation of IRB policy, University policy, and IRB approved protocols.  The Associate Vice President for Research and Director of the Office for Research Protections has the authority to enforce corrective action if an investigator does not cooperate with the review.

Routine vs Directed Post-IRB Approval Reviews

    

Routine

Routine or not-for-cause reviews are reviews occur when the Quality Assurance team will review study documentation to ensure regulatory compliance including protocol adherence, accurate record keeping, and appropriate informed consent process.  Studies approved at the committee-level and studies approved at the expedited-level that also are federally-funded, involve vulnerable populations, involve sensitive topics, or are FDA-regulated are most commonly selected for these reviews. 

    

Directed

Directed or for-cause reviews are conducted when the IRB directs the Quality Assurance Program to conduct an onsite review.  As with routine reviews, the Quality Assurance team may review protocol adherence, data management, and the informed consent process, as well as any study details related to the cause of concern.  The most common reasons for directed reviews are to investigate a credible allegation of non-compliance and to follow up on IRB findings of non-compliance.  Directed reviews are not always related to non-compliance

The following may trigger a directed review:

  • Reportable new information
  • An allegation of non-compliance (perceived or confirmed)
  • A suspension or termination of IRB approval
  • Participant and/or employee complaint

 

Review Preparation

To help investigators and study team members, Quality Assurance will share an agenda prior to the meeting.  Most onsite post-IRB approval reviews will take place at the investigator's lab or office and will include a discussion with the PI or study staff about the study protocol.  Most reviews also include an audit of storage procedures for maintaining confidentiality and an audit of participant documents such as signed consent forms and eligibility screening forms.  Reviews may also involve, for example, observation of study procedures or the consent process.  To prepare for a post-IRB approval review PIs and study team members should know where to access and/or be aware of the following information: 

  • General protocol and procedures
  • Enrollment numbers
  • Recruitment process, including eligibility screening
  • The consent process
  • Data collection 
  • Privacy, confidentiality, and data storage
  • Interaction with participants
  • Study team training and roles
  • Communication within the study team
  • Adverse events and other reportable new information

Please leave data and participant documents in their current storage.  Please do not print documents from CATS IRB for the reviewer(s). We bring our own copies.

Study teams should be aware of the differences between directly and indirectly identifiable data and the best practices and requirements related to annonymization and de-identification. For guidance, reference the Identifiable Data Info Sheet. In addition, there will be time for the study team’s questions and comments about the IRB and human subjects protections generally.

Review Attendance

Typically, the meeting is with just with the PI, the PI and the project coordinator(s), or only the project coordinator(s).  However, the PI can invite whomever they would like to attend. The Quality Assurance team may also request that particular personnel attend. 

Study team personnel need not be present for the document review, but there should be at least one person readily available in-person to answer questions.

Report Summary 

All post-IRB approval reviews conclude with a report that is submitted to the IRB as part of the documentation associated with the reviewed or audited study.  These reports inform the actions required by the study team and IRB to address any comments or findings of the review, such as the need for additional training. Investigators will have an opportunity to review and comment on the report prior to finalization.  There is no further action needed if there are no findings during the post-IRB approval review.  However, if there are any findings during the post-IRB approval review, the Quality Assurance team will direct the study team to submit the final report to the IRB as Reportable New Information or as a Modification depending on the level of finding.  If the study team does not submit the report by the deadline provided, the Quality Assurance team will submit the report to the IRB citing non-compliance.  In the report, the Quality Assurance program will provide recommendations to address findings and may advise that a Corrective and Preventative Actions (CAPA) plan be submitted to the IRB by the study team.  The IRB will work with the study team to address findings requiring action, such as making a modification to the protocol or handling non-compliance. 

Abbreviated or Self-Assessment Reviews 

Abbreviated reviews are most typically asked of studies determined exempt or approved at the expedited-level.  Investigators can use the checklists linked below at anytime to do a self-assessment of their study.  If asked to complete a checklist, the investigator will receive an email along with a completion deadline.  Depending on the answers provided, there may be additional follow-up.  Investigators can find the checklists uses for the abbreviated reviews linked below:

 

Be sure to schedule enough time to complete the checklist and to ask questions as needed.  It usually takes investigators no more than approximately 30 minutes to complete the self-assessment.  The self-assessment may take longer for those less familiar with the IRB approved protocol, study submission history, IRB policies, or CATS IRB.