All continuing reviews require submission of the most recent version of the continuing review form (click here to download)
Prime Grant CR: If you have a study that is an Umbrella or Prime Grant that requires continuing review, please download the PRIME continuing review form (click here to download). Please follow the applicable instructions for the format of your prime grant (HSERA vs. Paper)
Paper Studies: After completing the submission form, please print and send to the IRB office with one copy of each required supporting document. PI signature is required for all paper submissions.
What is the purpose of continuing review?
Continuing Review is the process by which the IRB re-evaluates whether a protocol is being conducted in compliance with the criteria for approval that are applied during initial review. Continuing approval is required for all submissions classified as either expedited or convened review at least annually (364 days of approval). The expiration date for a submission is noted in the original approval letter and will be provided on the stamped informed consent form (if applicable).
If a study lapses in approval at any time, no research related activities may occur, unless the PI contacts the IRB in advance and it is determined that continuation during expiration is appropriate for subject safety. If any activity has occurred during the lapse in approval, those activities should be documented in the appropriate section of the continuing review form.
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.
Steps for Creating a Continuing Review in HSERA
1. After completing the submission form, save it to your desktop (be sure to update the file name to indicate the protocol number, that it is a continuing review form, and the date).
2. Go to HSERA.
3. In the blue menu on the left side of your screen look for "Create" under "My Submissions".
4. After clicking "Create" you will be brought to a new screen where the various application types are available. Click "Continuing Review"
5. After clicking "Continuing Review" you will be brought to a screen with a list of all HSERA studies for which you are listed as either PI, Co-PI or Study Contact (note that Key Personnel cannot create submissions). Check to make sure your filter is clear. Then enter the protocol # you wish to make a continuing review for and click "Filter".
6. After clicking "Filter" with the specific protocol number entered, you should see one entry with columns showing the PI name, Submission date, Title, and a Select column - click the white and yellow "Select" button.
7. After clicking the "Select" button you will be taken to the first page of the Continuing Review submission. There are 3 pages to complete:
- Page 1 requires that users indicate the level of review required for this continuing review. This decision is based on the risk level of the study. Please refer to your Initial approval letter to determine whether your study is expedited or convened if you are not sure. The next field after selecting level of review is where you attach your completed continuing review form that you downloaded from this page.
- Page 2 contains only the standard question about financial conflicts of interest. You should enter the same responses you provided in the attached form. Other offices in the University rely on the HSERA responses so this question will continue to appear in both places.
- Page 3 is where you will attach the appropriate documents related to the continuing review. Please be mindful to upload documents under the appropriate header to facilitate the IRB's review of these documents.
Drafting a Monitoring Summary for Greater Than Minimal Risk Biomedical Research
This is the newest component to IRB continuing review. It is required for all greater than minimal risk biomedical research that had active subjects during the year being reported. The purpose of the monitoring summary is to ensure the proposed SITE monitoring plan is being adhered to. This is separate from study wide monitoring for safety and effectiveness that may be performed by a sponsor or safety board. Download the guidance document.
Can I submit a modification while my Continuing Review is pending approval by the IRB?
Due to complications that occur with submission of modifications at the same time as continuing review, the IRB strongly suggests avoiding creating both at the same time unless absolutely necessary. Unless you are instructed by an IRB staff member to create and submit a modification at the same time as your continuing review, study teams should instead mention the basic elements of the planned modification in the progress report that is required for all continuing reviews and wait to create and submit the modification until after the continuing review has been approved.
Submitting Continuing Review When Penn Serves as the IRB of Record for Multiple Sites (Reliance Agreements/Central IRB Review)
Submitting Continuing Review for studies where Penn serves as the central IRB requires specific documentation from each site. Please download and review our guidance prior to submitting continuing review for these studies.
What if my study is expired?
Continuing review for minimal risk research is due at least 2 weeks (14 days) prior to the expiration date
Continuing review for greater than minimal risk research is due at least 6 weeks prior to the expiration date.
If your study is expired the IRB will expect the following information to accompany your continuing review request:
- A description of all activity that has ocurred during the lapse in approval
- an explanation for what lead to the delayed submission of the continuing review
- a corrective action plan to avoid expiration in the future
- If a study has expired more than once please comment on whether the existing corrective action plan needs to be corrected
- If your research is greater than minimal risk and activities need to occur during the lapse for the benefit of participants, please provide rationale for this in order to consider an exception.