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CONTINUING REVIEW / CLOSURE


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

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.

 

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.

Reminder Notices

IRBManager automatically sends continuing review reminder notices for each active study at 45, 30, and 25 days prior to expiration. 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.

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. 
 

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.
 

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.
 

Lapse in IRB Approval

 

If IRB Approval Lapses

If IRB approval lapses 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 continue, s/he must notify the IRB Office 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).

How to Resume the Study

The investigator may resume research activity once a Renewal application has been reviewed and approved by the IRB.

Time Limits

Investigators have up to 60 days after the IRB approval lapses to obtain continuing approval. After 60 days, the IRB will permanently close (expire) the study and a new study must be submitted for review if the investigator wants to continue the research.

Resources