Post-IRB Approval Reviews

The Quality Management program conducts post-IRB approval reviews to enhance the protection of human subjects and the oversight of approved research. The reviews will be completed to verify that IRB approved procedures are being followed.  In addition, the IRB will use the results to develop researcher education and improve IRB processes/procedures/guidance.

If you have questions about post-IRB approval reviews, email us at ORP-QM@psu.edu. 

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. After the meeting, a report is drafted and submitted to the IRB. 

Any study determined exempt or approved by the University Park IRB may be selected for a post-IRB approval review.

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 routinely selected. These types of reviews are not-for-cause.

The IRB can also direct us to conduct onsite reviews. 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 onsite reviews, however, are not always related to non-compliance; some directed reviews are also not-for-cause.

Failure to cooperate 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.

All reviews include a discussion with the PI or study staff about the study protocol. Most all reviews 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.

During the visit, the Quality Management team will help you correct problems that can be fixed onsite.

The meeting ends with a discussion of what will be included in the report to the IRB.

Meetings are typically scheduled for between 1 and 2.5 hours. If a review will take longer than this, based on the nature of the review and the investigator’s preference we may suggest the review occur over multiple meetings. 

The Quality Management team will go to the investigator's lab or office for the meeting to allow for easy access to participant documents, master linking lists, etc. and other study related docments as they are stored by the study team.

We know that post-approval reviews can be burdensome for investigators, and we do our best to minimize the burden and stress. The onsite meetings are conversational, not confrontational.

Within the week before the meeting, if not earlier, QM will provide you with its discussion agenda, to which you can add your own topics. The following are topics commonly covered during the onsite meetings:

  • Enrollment numbers
  • Recruitment
  • Eligibility screening
  • The consent process
  • The data collection process
  • 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

In addition, QM always provide ample time for the study team’s questions and comments about the IRB and human subjects protections generally.

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.

Unless we explicilty request otherwise, which we typically don't, you are not required to prepare anything for the post-IRB approval review..

However, the more issues you resolve before the onsite meeting, the less likely the review will result in findings for the study team. Review the IRB protocol and IRB policies to ensure you are adhering to both, and if not, take corrective action. If your study was approved by the committee or through expedited review, you can use “HRP-430 - Checklist - Investigator Quality Improvement Assessment” in the CATS IRB Library to help you with this. If your study was determined exempt, you can use “HRP-439 - Checklist - Investigator Quality Improvement Assessment (Exempt Research).”

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.

Self-Assessments 

The 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. Upon receipt of the completed checklist, a brief report will submitted to the IRB including any findings.

If your study was approved by the committee or through expedited review, we will ask you to complete “HRP-430  - Checklist - Investigator Quality Improvement Assessment” in the CATS IRB Library. If your study was determined exempt, you will be asked to complete “HRP-439 - Checklist - Investigator Quality Improvement Assessment (Exempt Research).”

 Any study determined exempt or approved by the University Park IRB may be selected for a self-assessment. 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 IRB can also direct us to conduct a virtual review for-cause. The most common reasons for directed virtual reviews are to investigate a credible allegation of non-compliance and to follow up on IRB findings of non-compliance.

The virtual reviews are self-assessments and are primarily an educational activity, but the virtual reviews are still considered official audits.

As is true of onsite audits, failure to cooperate with a virtual review 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.

You will receive an email with a deadline to complete the self-assessment, and when you return the completed checklist, we will follow-up with any questions. After that, we send a brief report to the IRB and attach the completed checklist.

We encourage individuals completing the checklist to call us if they have questions about particular items on the checklist. We will also work one-on-one with you to complete all checklist items.

It usually takes investigators no more than approximately 30 minutes to complete the self-assessment. The self-assessment may take longer if you are not familiar with your protocol, study submission history, IRB policies, or CATS IRB.

Review Reports

The 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. The report is submitted as part of the study submission.

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.
Investigators know any findings for their study team, and typically for the IRB, before the report is sent to the IRB. We welcome investigators to see and comment on our reports before we submit them to the IRB. This is especially important for reports of onsite visits that have significant findings and for visits that are follow-ups to non-compliance.

Not necessarily. “Non-compliance” is an official, or procedural, determination made by the IRB, not the Quality Management program. The Quality Management team's findings include what may constitute non-compliance but also other issues that might improve the protocol, such as the possible need for a modification.  Audit findings are recommended "action items" for the investigator or the IRB. Most findings are not deemed non-compliance by the IRB.

The IRB will contact you if the report includes items that need you or the IRB to act upon, such as making a modification to the protocol or handling non-compliance.

If no action is needed, then you will usually only receive an email from the CATS IRB system notifying you that the IRB has acknowledged receipt of the report.