Continuing Review FAQs

1. Submit the Continuing Review application as soon as possible. Extension of the IRB expiration date may only be achieved by submission of a continuing review. Other submission types (modification, exception request, deviation) cannot serve as a renewal submission.
2. If any activity has occurred during the lapse in approval, those activities should be documented in the appropriate section of the continuing review form for committee review. Likewise, the study team should provide a root cause for the lapse in approval as well as a preventative action plan as to how they will avoid delayed submissions in the future. If a study has expired more than once, please comment on whether the existing corrective action plan needs to be corrected.
3. If there are participants active on research intervention / treatment that cannot cease due to safety reasons, the Principal Investigator (PI) must contact the IRB as soon as possible to request an Exception Request for these participants to continue on active treatment during the lapse. The PI should provide rationale as to why continuation during the lapse is in the best interest of the participants, and how ceasing research treatment would create increased risk to the participants.

How to Submit an Exception Request

The Penn IRB defines “enrolled” as an appropriately informed individual agreeing to participate in a study. In other words, an enrolled participant is an individual who may be eligible for participation, has provided informed consent, and may have participated in some or all study procedures including procedures that determine eligibility (if applicable). It is this definition of enrolled that should be used to determine the number of participants to be enrolled as indicated on all study documents. This definition allows for consistency of enrollment review across all projects and ensures that for studies that may include “screening procedures” or “pre-screening procedures,” the individual is “enrolled” in the study to allow these study procedures to be done.

Current federal guidelines include that at the time of continuing review, “the IRB’s responsibility to protect human subjects should include the IRB’s review of trial progress. For example, expected rates of enrollment and dropout are generally identified for most studies. A marked difference between the actual and expected rates of enrollment or dropout, either at an individual site or in the study as a whole, may indicate a problem requiring further investigation.”

The IRB recognizes that commercial sponsors, and others, may have a different definition, such as considering an individual “enrolled” in a study when the participant has been assigned to a study arm or has taken their first dose of the study drug. If the sponsor provides such definition, the study team may include that description and expected number in the HSERA application and continuing review progress report.

However, as noted above, the study documents including the Continuing Review Form must reflect the enrollment number of those individuals who are appropriately informed and agree to participate in a study. Study teams may differentiate between screen failures and eligible subjects in their progress reports.

The system will also allow a modification to be submitted concurrently while a continuing review is pending (or vice versa). However, a soft stop and a warning will appear, but you may proceed. However, the IRB recommends that study teams do not submit concurrent modification / continuing review submissions, unless absolutely necessary, due to complications that can occur, as detailed below.

HOWEVER, IF YOU ARE WAITING ON A MODIFICATION APPROVAL AND YOUR CONTINUING REVIEW EXPIRATION DATE IS APPROACHING, DO NOT WAIT TO SUBMIT YOUR CONTINUING REVIEW SUBMISSION.

If you must submit concurrent modification / continuing review submissions, please note the following:

• You must reach out to the IRB staff to facilitate the processing of these submissions and ensure that the correct documents are approved in the continuing review submission. For greater than minimal risk studies requiring convened board review, please email BOTH the coordinator and administrator for the study’s assigned board https://irb.upenn.edu/directory. For minimal risk research, please email the PROVOST-IRB@pobox.upenn.edu.
• It is the recommendation of the IRB that you create and submit the modification first before creating the Continuing Review (CR) application. This is to make sure that changes made within the HSERA modification submission are carried over into the continuing review application. If you do not do this, you may lose changes you made in HSERA if the create the CR first. It is preferred that the continuing review application be created after the approval letter for the modification has been uploaded for this reason.