RENEWALS AND CLOSURE REQUESTS
Federal regulations require an IRB to conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year. Recent changes to the Common Rule, however, allow for exceptions to this general rule. Specifically, continuing review of research is no longer required for:
- Minimal risk research reviewed and approved by the Expedited procedure; and
- Greater than minimal risk research (reviewed and approved by the Full Board) that
has progressed to the point that it involves only one or both of the following:
- data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
For these and also Exempt studies, however, LSUHSC IRB policy requires Study Status Updates every three years until Closure of the study.
Continuing Review/Renewals
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 a Renewal to the IRB Office as described below.
Continuing Review Date versus Expiration Date
The Continuing Review Date listed in KR is the last day the study has IRB approval. The Expiration Date is set to 60 days after the approval has lapsed; on this date, the study will be administratively closed if a Renewal application has not been received by the IRB.
How to Submit
Continuing reviews are submitted using the Renewal form in the Kuali Research (KR) electronic submission platform. Links to instructional material are provided below under Resources.
When to Submit
To ensure adequate time for the IRB to review a Renewal application, the Principal Investigator is required to submit the Renewal form no later than 30 days (for studies approved by the Full Board) or 15 days (for studies approved by the Expedited procedure) before the Continuing Review Date, the date which signifies the end of study approval.
Reminder Notices
As a couresty, to prompt submission of a Renewal application in a timely manner, KR sends continuing ceview reminder notices for active studies at 45, 30, and 15 days prior to the end of the study approval period (i.e., Continuing Review Date). All study team members will receive these notices and the team should initiate a Renewal or Closure Request (see below) application as applicable.
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.
Status Updates
For ongoing studies that are, or have become, exempt from continuing review, investigators must submit a Status Update every three years. Status Updates are submitted using the Renewal form in KR. Links to instructional material are provided below under Resources.
Lapse in IRB Approval
If IRB Approval Lapses
If IRB approval lapses (i.e., the Renewal application has not been approved by the Continuing Review Date), 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, in which case s/he must notify the IRB Office promptly. 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).
How to Resume the Study
The investigator may resume research activity once a Renewal application has been reviewed AND approved by the IRB. Renewal approval must be obtained before the study Expiration Date, which is 60 days after the Continuing Review Date.
Study Expiration and Administrative Closure
A lapsed study that has not obtained Renewal approval by the Expiration Date will be administratively and permanently closed. Please be mindful of these notifications and take appropriate actions to prevent permanent closure of the study. A study that is permanently closed cannot be re-activated. Continuation of research that is administratively closed will require submission, review and approval of a completely new protocol in KR.
Study Closure
When to Close a Study
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
Closure Requests are submitted in KR. Links to instructional material are provided below under Resources.
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.
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. Investigators should also honor any other commitments that were agreed upon as part of the approved research. For example, providing information about the study results to research participants or honoring reimbursement commitments for participation.
