How to Submit 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.
Timeline for Continuing Review
- Continuing review is required, not less than once per year, for all submissions determined to be greater than minimal risk by the Institutional Review Board.
- Minimal risk research reviewed under the old Common Rule (pre-2018) requires continuing review, not less than once per year, unless the IRB has determined that continuing review is no longer required.
- Minimal risk research reviewed under the 2018 Common Rule (submitted after January 2019) generally does not require continuing review. However, as permitted by the 2018 Common Rule, continuing review may be required by the IRB for some research, such as FDA regulated research. In this case, continuing review is required not less than once per year.
When continuing review is required, the expiration date for a submission is noted in the original approval letter and will be provided on the stamped informed consent form.
Required Timeframe to Submit a Continuing Review Application to Avoid a Lapse in IRB approval
Greater than Minimal Risk Research
Continuing review for greater than minimal risk research requiring convened board review is due to the IRB at least 6 weeks prior to the expiration date.
Minimal Risk Research
When continuing review is required for minimal risk research, it is due to the IRB at least 2 weeks (14 days) prior to the expiration date.
How to Submit Continuing Review
This section details instructions on how to submit a continuing review submission.
-
-
Complete the Word version of the continuing review submission form. All continuing review submissions require submission of the most recent version of the Word version of the continuing review form. Failure to submit this form will result in the IRB returning your submission.
- Penn Medicine Research: For Greater Than Minimal Risk protocols where there is no sponsor appointed monitor, complete the PICA via REDCap. The PICA can be completed by any member of the study team, but PI review and confirmation via signature is required. If you have questions about the PICA form, please contact OCR Compliance at psom-ocrcompliance@pobox.upenn.edu. Do not submit the PICA to the IRB.
-
Draft a progress report. This is a cover letter that should contain the following content:
- A narrative summary of the study activities that occurred during the approval year including notable comments, notable subject experiences, any delays in study activities, a summary of any deviations that required expedited reporting in the past year, a summary of any adverse events that required expedited reporting in the past year, and expected activities for the coming year. Please do not re-iterate the enrollment numbers provided in this form unless a specific clarification is needed.
- For all IRB submissions for Greater Than Minimal Risk: A complete list of documents being submitted for review. Each listed item must include the name of the document, version identifier and date (e.g. – Study Protocol version 7, dated 9/26/2017)
- A summary of any planned/outstanding modifications that will be submitted to the IRB for review including the planned timeline for submission and the impact the modifications have for enrolled subjects, as applicable.
-
After completing your progress report along with the continuing review submission form, save these documents to your computer.
-
Compile the remaining required documents for continuing review [standalone protocol (if applicable); investigator’s brochure(s), package insert(s) or device brochures (if applicable); and consent form(s) to be used for enrollment or reconsent].
- Please ensure that all documents provided are in a searchable format, and not a scanned PDF. It is the responsibility of the study team to keep current editable versions of study documents in case changes to study documents are needed.
- Please ensure that consent form(s) are submitted in Word version (preferred) or searchable PDF format. Please do not submit the currently stamped version of the consent form, as the document has to be re-stamped.
- The IRB strongly recommends the file names of the documents indicate the protocol number, document (e.g., CR form), and the date). This will facilitate IRB review processes.
-
Submit all documents in HSERA for studies originally submitted in HSERA. Submit paper studies as directed below.
Important Points to Remember
Prime Grant Continuing Review
If you have a study that is an Umbrella or Prime Grant that requires continuing review, please use the PRIME continuing review form. Please follow the applicable instructions for the format of your prime grant (HSERA vs. Paper)
Paper Submissions
Because the IRB office is closed to the research community, please submit electronic versions of all relevant study documents and a scanned version of the signed form for paper submissions to the IRB PO Box so that submissions may be reviewed electronically.
Continuing Review for Penn as sIRB
Submitting continuing review for studies where Penn serves as the central IRB of record for multiple sites requires specific documentation from each site. Please click on the link below to review our Post-Approval Submission Guidance when Penn is the Single IRB of Record prior to submitting continuing review for these studies. Associated forms are located on the IRB Forms page.
Continuing Review when Penn Relies
When Penn IRB relies on an external IRB, study teams are responsible for submitting continuing review approval letters to the Penn IRB to the Penn IRB. PICA forms are still required to be submitted to by Penn Medicine researchers to OCR for greater than minimal risk research. Please click on the link below to learn more and review the External IRB Review FAQs.
If a study lapses in approval at any time, research related activities must cease immediately, including enrollment of participants.
What if my study is expired / lapsed in approval?
Click below for guidance on lapsed approval and other continuing review frequently asked questions (FAQs).