Post-IRB Approval Reviews

Quality Management (QM) conducts post-IRB approval reviews in an effort to ensure the highest level of research participant protections. QM is separate from the IRB, and post-approval reviews are distinct from IRB continuing reviews and include an assessment of the IRB, as well as the study team.

QM conducts both onsite and virtual audits.

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, QM internally audits IRB records for the study to assess the timeliness and quality of IRB approvals. After the meeting, QM prepares a report that we submit to the IRB.

QM may select any study determined exempt or approved by the University Park IRB.

For onsite reviews, QM most routinely selects 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. Reviews of routinely selected studies 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, QM staff will help you correct problems that can be fixed onsite.

The meeting ends with a discussion of what QM intends at that time to include in its report to the IRB.

We typically schedule meetings 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 QM staff member leading the review will suggest the length of time that should be blocked off for the review.

QM goes to the investigator. Meetings usually happen in the investigator’s office or lab. One reason for this is that we want to see participant documents, master linking lists, etc. 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 QM meets with just with the PI, the PI and the project coordinator(s), or only the project coordinator(s). However, the PI can invite whomever he or she would like to attend. QM may also request that particular personnel attend.

Usually, only one QM staff member attends the meeting.

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 QM.

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).”

Also, the QM staff member leading the review can provide advice on how to ready for the meeting.

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

Virtual Reviews

QM conducts virtual reviews through investigator self-assessments. QM sends a checklist to the investigator with a completion deadline. When the investigator returns the completed checklist, QM submits the checklist and a brief report 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).”

QM may select any study determined exempt or approved by the University Park IRB. However, for routine reviews, we typically conduct virtual reviews for 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.

Youwill  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.

When QM has worked one-on-one with investgiators to complete a checklist, it usually takes no more than approximately 10 minutes. The self-assessment could take much longer if you are not familiar with your protocol, study submission history, IRB policies, or CATS IRB.

Review Reports

QM submits a report to the IRB after all onsite and virtual reviews, regardless if QM has findings or not. QM submits all reports of post-approval reviews to the IRB through the 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.), QM findings on the study team and the IRB, and other reminders or notes that QM chooses to document. For virtual reviews, the report usually only includes findings and any recommendations we have to the IRB.
Investigators know any findings for their study team, and typically for the IRB, before QM sends the report 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 or of visits that are follow-ups to non-compliance.

Not necessarily. “Non-compliance” is an official, or procedural, determination made by the IRB, not QM. QM’s findings include what we think may constitute non-compliance but also other issues that we feel 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 reviews do not have findings. Most QM 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 QM report.