Continuing Review & Closure
Continuing Review is a federally mandated re-evaluation of an approved study that is required to be conducted at least once per year. For most new non-exempt, minimal risk, and non-FDA regulated research projects, there will no longer be an expiration date and therefore, no requirement for annual continuing review. Otherwise, continuing Review is required until the Principal Investigator has completed all research-related interactions and interventions with participants or when the collection and analysis of identifiable private information, as described in the IRB-approved research protocol, has been completed.
This review allows the IRB to monitor the progress of the study and ensures that the study continues to meet the requirements for approval. The continuing review process begins when the Principal Investigator submits the Continuing Review information to the IRB Office through eIRB+.
- To ensure that there is adequate time for the IRB to process the Continuing Review, the information should be submitted no sooner than 60 days but no later than 30 days before the study’s expiration date. For studies that have an expiration date, it is located on the main study page of the study in eIRB+.
Deadlines and Reminders
When To Submit
The Principal Investigator is responsible for submitting the Continuing Review information no sooner than 60 days but no later than 30 days before the study’s current expiration date to ensure adequate time for the IRB to process the Continuing Review. For studies that have an expiration date, it is located on the main study page of the study in eIRB+
Reminder Notices
eIRB+ automatically generates continuing review reminder notices for each active study. The Principal Investigator and the Primary Contact will receive these notices.
Internal Reminders
Investigators are strongly encouraged to devise an additional system for ensuring the submission of continuing reviews. Suggestions include setting reminder notices in electronic calendars and frequent meetings with study staff to review expiration dates.
Preparing the Continuing Review in eIRB+
Before Submitting The Research For Continuing Review
- Determine whether any member of the study team has a financial interest related to the research. A "yes" or "no" answer is sufficient. There is no need to provide additional details.
- Determine if you need to submit a modification at the same time.
- If your first submission in eIRB+ is a continuing review, we ask that you submit a combined "Modification and Continuing Review" that includes the changes requested in the "NU eIRB+ Implementation Study Conversion Checklist for Research Personnel" document.
How Do I Submit My Continuing Review Submission?
- Access to eIRB+ is available via this site's eIRB+ page.
- After logging in, choose “My Studies” and filter by PI or Study Number to find the applicable study.
- Choose the applicable study from the resulting list.
- The “home” page for the study will appear. In the left-hand side of the study workspace, you may click "Create Modification/CR" button.
- Choose either "Continuing Review" to provide updates for an active study or when requesting to close a study. You may also select "Modifications and Continuing Review" if you wish to make also make changes to your study at the time of continuing review.
-
It is recommended that you submit study team member changes in a separate modification and not combine it with a CR. Study team member (Not PI’ or Co-I’s) modifications are approved automatically by the eIRB+ system.
-
- After clicking the appropriate button, the form will open. You must complete all questions.
- When you have reached the Final Page of the application, click "Finish". Neither of these activities actually submits the continuing review form to the IRB Office. You can always return to the application to make edits by clicking the "View Periodic Review" button.
- The "Printer version" button displays the form in an uneditable single continuous document:
- To submit the continuing review form to the IRB, the PI or PI proxy must click the "Submit" button on the main page of the new study.
Following Your eIRB+ Submission
The eIRB+ system uses states to classify where a submission is in the process. See Following Your eIRB+ Submission for typical study states and any required actions.
Continuing Review with Modifications
The eIRB+ system allows for the submission of a Modification during the processing of a Continuing Review. Access to eIRB+ is available via this site's eIRB+ page.
- After logging in, choose “My Studies” and filter by PI or Study Number to find the applicable study.
- Choose the applicable study from the resulting list.
- The “home” page for the study will appear. In the left-hand side of the study workspace, you will select "Create Modification/CR" to make any changes to your study at continuing review.
- After clicking the appropriate button, the form will open. You must complete all questions. You can make edits by clicking the "View Periodic Review" button.
- When you have reached the final page of the application, click "Finish" or "Exit". Neither of these activities actually submits the continuing review form to the IRB Office.
- To submit the Modification/CR to the IRB, the PI or PI proxy must click "Submit."
Note: It is recommended that you submit study team member changes in a separate modification and not combine it with a CR. Study team member (Not PI’ or Co-I’s) modifications are approved automatically by the eIRB+ system.
Closing a Study
When To Close A Study in eIRB+
If all research-related interventions or interactions with participants have been completed and collection and analysis of identifiable private data (as described in the IRB-approved protocol) are finished, the study should be closed with the IRB.
How To Close A Study in eIRB+
To close a study in eIRB+, a Continuing Review submission should be completed by the PI. At least the first 4 statements in the Research Milestones section should be selected and true. Selection of the first 4 statements will close the study.
The IRB may request additional information to ensure that the study is in good standing and ready to be closed. Once the submission is approved, the study is considered Closed by the IRB and will be archived. If an investigator wishes to resume the research after the study has been closed or if the study is closed in error, a new study will have to be submitted.
Industry sponsored initial studies submitted on/after September 1, 2021 will be charged a study closure. More information is on the IRB Fees webpage.
Once a study has been closed, investigators may keep the data collected (including identifiable, private data) if consistent with the IRB-approved protocol. Investigators should continue to honor any confidentiality protections of the data and any other commitments that were agreed upon as part of the approved research.
Additional guidance on study closure can be found on the Policies & Guidance page.Expired Studies
If IRB Approval Expires
If IRB approval expires before continuing review and approval occur, the investigator must stop all research activities related to that study, except when the investigator judges it to be in the best interest of current participants to continue. If the investigator judges it to be in the best interest of current participants to continues/he must notify the assigned IRB analyst promptly via email. If the Board determines it is not in the best interest of current participants to continue, all research activities must stop. This includes intervening / interacting with subjects and/or obtaining or analyzing identifiable private information about the participant(s). (see 45 CFR 46.103(b)).
How To Resume The Study
The investigator may resume the research activity once continuing review has been reviewed and approved by the IRB.
Time Limits
Investigators have up to 60 days after the study expires to obtain approval. After 60 days, the IRB will permanently close the study and a new study must be submitted for review.