RENEWALS AND CLOSURE REQUESTS
Renewal and Continuing Review
LSUHSC-NO IRB renewal or continuing review occurs through the submission of a Renewal or Renewal/Amendment (if changes are required) application in Kuali. Renewal or Renewal/Amendment submissions should be submitted at least 45 days prior to Expiration Date to allow sufficient time for review prior to lapse. If a submission is made 45 days prior, IRB staff will not close the study should it expire while under review.
LSUHSC-NO IRB authorization must remain active at all times in order for research activities to continue.
How to Submit
Continuing reviews are submitted using the Renewal or Renew/Amend form in the Kuali Research electronic submission platform. Links to instructional material are provided below under Resources.
Internal Reminders
LSUHSC-NO IRB authorization for research activities ends on the Expiration Date displayed in the Kuali protocol. Automated reminders are issued through Kuali 60 and 30 days prior to expiration or continuing review deadline, as applicable. A final notification is also sent on the day the protocol lapses.
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.
Lapse in IRB Approval
If IRB Approval Lapses
If LSUHSC-NO IRB approval or acknowledgement lapses, the investigator must cease all research activities immediately.
If the primary investigator (PI) determines that study continuation is necessary to protect participant safety, a temporary continuation of authorization of specific activities may be considered. In such cases, the PI should immediately contact the IRBOffice@lsuhsc.edu with subject line: Request for Study Continuation for Participant Safety Risk. The request must include, as applicable, a list of the affected subjects, their treatment/participation status, and an explanation of why it is in their best interest to continue participation.
Resuming Research Activities
The investigator may only resume research activity once LSUHSC-NO IRB authorization has been restored through approval of the Renewal (or Renew/Amend) submission.
Administrative Closure
A lapsed study that has not obtained the appropriate renewal approval by the Expiration Date will be administratively and permanently closed.
A study that is permanently closed cannot be re-activated. Any future conduct of the research will require submission, review and approval or acknowledgment of a completely new protocol in Kuali.
External Reliance
The above processes also apply to LSUHSC-NO IRB acknowledgement when LSUHSC serves as the relying institution. Local study activities must pause if LSUHSC-NO IRB acknowledgement lapses, as indicated by the Expiration Date listed in Kuali, even if approval from the IRB of Record remains current.
Revisions in Progress
Protocol submissions that remain in “Revisions in Progress” status for more than 60 days will be administratively abandoned. If additional time is needed due to extenuating circumstances, please contact the IRBOffice@lsuhsc.edu to request an extension, including a justification and an estimated timeframe for completion of the required revisions.
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 Kuali. 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.
