Post-IRB Approval Reviews

The Research Quality Management program conducts post-IRB approval reviews 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. 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 force corrective action if an investigator does not cooperate with the review.

There are two different types of post-IRB approval reviews: "onsite" and reviews self-assessments. The details about each review type are explained below.  

All post-IRB approval reviews conclude with a reprot drafted by the Research Quality Management program. Althought the Research Quality Management program is independent from the IRB, reports for post-IRB approval reviews will be shared with the IRB. These reports inform the develop researcher education and improve IRB processes/procedures/guidance.

Onsite Reviews

An onsite review is an in-person meeting with study staff to collect information related to human subjects protections not found in the IRB records, to ensure that investigators are following IRB policies and the approved protocol, and to review study documents, data, and their storage. Prior to the meeting, IRB records for the study are reviewed to assess the timeliness and quality of IRB approvals.

Routine vs Directed Onsite Reviews

    

Routine

Routine or not-for-cause reviews are reviews occur when the Research Quality Program 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 condcuted when the IRB directs the Research Quality Program us to conduct an onsite review. As with routine reviews, the Research Quality Program 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

 

Onsite Review Preparation

To help investigators and study team members, the Research Quality Program 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, interviews with subjects and 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 proceedures
  • 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.

In addition, there will be time for the study team’s questions and comments about the IRB and human subjects protections generally.

Onsite 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 Management 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.

Self-Assessments 

However, self-assessment are most typically asked of studies determined exempt or approved at the expedited-level. Among those studies, we often randomly select studies that are federally-funded, involve vulnerable populations, involve sensitive topics, or are FDA-regulated. Routine studies are not-for-cause.The Research Quality Management team also uses investigator self-assessments as a way to ensure IRB approved procedures are being followed. If asked to complete a self-assessment checklist, the investigator will recieve an email along with a completion deadline.

Self-Assessment Preparation

To prepare for the self-assessment, review the appropriate checklist.  There are two different self-assessment checklists:

 

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.

Review Reports

The Research Quality Management program is responsible for submitting a report to the IRB after all onsite reviews and self-assessments, regardless of whether there are findings. These reports are submitted as Reportable New Information (RNI) function in CATS IRB.  For onsite reviews, the report usually includes an overview of the onsite review activities (discussion topics, records reviewed, etc.), findings of potential non-compliance or general concerns for either the study team or the IRB, and other reminders or notes. For self-assessments, the report usually only includes findings and any recommendations to the IRB.

The IRB will contact the study team if the report includes items requiring action, such as making a modification to the protocol or handling non-compliance. Audit findings are recommended "action items" for the investigator or the IRB. Most findings are not deemed non-compliance by the IRB. If no action is needed, then the PI and Primary Contact will usually only receive an email from the CATS IRB system indicating that the IRB has acknowledged receipt of the report.