Continuing Review (Study Renewal) and Project Closure

The process for requesting continuing review and for closing out a project is made through the Cayuse IRB-Human Ethics online system. Information about this system can be found by visiting IRB Cayuse. The IRB reviews Renewals at its regularly scheduled meetings.

Project Status

The researcher must check the appropriate box on the form that reflects the current status of the study. Studies cannot be closed if any activity, including data analysis, is still underway or planned. If all data collection is complete, but the researcher is still analyzing data, the box “Active-Post-Enrollment” should be selected. A study may become exempt from future continuing review if all data has been de-identified.

Approval Period 

Federal regulations require that the IRB conduct ongoing reviews of all full board protocols at intervals appropriate to the degree of risk, but not less than once per year. The interval is set for each protocol. Most full board protocols at UNI are approved for one year, although the approval period may be less if the IRB deems more frequent reviews necessary. Modifications that may have occurred during the year do not change or advance the approval period. The phrase “not less than once per year” means that the research must be reviewed within one year of the date of the IRB meeting at which the research was approved (with or without conditions). Factors to be considered by the IRB in determining the appropriate interval for periodic review include the following:

• involvement of vulnerable populations;
• research conducted internationally;
• the involvement of recombinant DNA or other types of gene transfer protocols;
• any waivers of informed consent procedures;
• research for which participants would be exposed to additional serious risks, such as breach of confidentiality;
• previous suspension of the research due to compliance, record-keeping, or other concerns; and
• studies that pose a very high level of risk to individual participants or some risk to a large number of participants.

In addition, at its discretion the IRB may require review more frequently than annually for studies conducted by investigators that have not been in compliance with IRB requirements in the past or studies being conducted by new investigators.

The frequency of continuing review may be changed at any point in the future. Examples of reasons for a change in the length of the approval period may include the following: (a) a large number of participant withdrawals, (b) participant complaints, (c) new information that indicates a change in the participant risk/benefit ratio, (d) unanticipated adverse events/complications that would affect the risk/benefit ratio, (e) a change in investigators, and (f) notification of changes in the consent process, research plans, the procedures, or the data collection methods. This list should not be considered exhaustive. However, should a more frequent review be required, the researcher will be provided with a statement of the reasons for the change.

Approval Dates and Communications 

The approval and expiration dates for the study will be shown in a formal letter of approval emailed to the investigator. Investigators will be informed if a continuing review is required and that they are responsible for submitting a Continuing Review request in sufficient time for review to occur prior to the study’s expiration date. Continuing Review requests and attachments should be completed in the Cayuse IRB-Human Ethics online system, preferably 45 days prior to expiration, or otherwise in sufficient time to be distributed prior to the next scheduled board meeting. For studies expiring over the summer, researchers may submit their renewal requests in the spring, before they leave for summer break; doing so will result in a new annual expiration date.

Reminders.  Approximately 30-45 days prior to the expiration date for all open full board studies, a notification will be emailed to investigators as a reminder that the study is about to expire. If no email is available for the investigator (typically a student who has left campus), the notification is emailed only to the advisor. If a faculty investigator has left campus, the IRB office attempts to locate a forwarding email for the faculty member. If there is no response to the initial email, a second reminder email is sent to the same individual, noting that study expiration is pending and that the study file will be closed upon expiration. If still no response occurs, the file is closed with a notation that the investigator was non-responsive to the IRB renewal/closure requirements. If the study was approved by the full board, a third and final email is sent, notifying the investigator that the study has in fact expired and reminding them that no further research is permissible without a new review.

Study Expiration

It is the investigator’s responsibility to ensure that his or her research is submitted for review in time for continuing approval. In the event that the study is not approved either through continuing review or via a new review process by the study’s expiration date, all research activities must stop unless and until approval is again obtained. The only exception to this is if stopping the research would cause harm to participants (e.g., by removing them from a clinical trial), in which case the IRB must be notified of this
immediately.

Failure to follow these policies and procedures is considered noncompliance. If research activities were to continue without or before renewing the study that would represent serious noncompliance.

Review Process for Active Projects 

For most projects that require ongoing approval, the lead reviewer assigned to the study will receive a copy of the past protocol and modifications from the study file, as well as the current Continuing Review request and materials. (For active projects in which no participants have been enrolled, or participant enrollment has been completed, the reviewer may simply choose to review the request and materials without examining the overall file.) The lead reviewer may email preliminary questions to the investigator prior to the IRB meeting. At the meeting, all IRB members will receive all current materials plus, in some cases, a summary of the protocol provided by the member facilitating the review. The investigator(s) (and advisors if applicable) are encouraged but not required to attend the meeting as well. Continuing reviews are in other ways similar to initial reviews, in that materials are reviewed, any concerns raised, and a vote taken on the protocol.  

Continuing Approval Category 

Most studies will be approved at the continuing review point in the same regulatory category under which they were originally approved. However, there are exceptions to this when the circumstances, including risks/benefits for participants, have changed. For example, a study originally approved as expedited may be reviewed by the full board at the continuing review point if new components have been added such that expedited review is no longer allowed, or simply because the lead reviewer wishes to consult with the other members of the board. 

As another example, studies that were originally reviewed by the full board may be subsequently reviewed under expedited procedures (i.e., by one reviewer) under the following conditions:  a) no participants have yet been enrolled; b) the study is inactive; c) the study is completed; or d) participant enrollment is closed and the study is in data analysis only. The results of expedited reviews for original full board studies are reported to the committee members on the IRB monthly status sheets.

Studies that are in the Active-Post-Enrollment phase may be approved as exempt at the continuing review point if the study now meets the criteria for exempt studies, including that all identifiers and/or links to identifiers have been removed from the dataset.

Project Closure 

Investigators must submit a  Closure request at whatever point the project is complete. Student researchers and all others completing projects in the middle of the approval period are encouraged to do this to avoid having to subsequently receive reminder materials after the end of the study. Students are often difficult to contact at the expiration point since they may have left campus by that time, in which case advisors are expected to complete materials on their behalf. Upon receipt by the IRB, the request will be forwarded to an IRB committee member for review, who will either share any questions or concerns they may have about the study with the investigator, or will approve closure of the study and the file will be closed by the IRB office.

Exempt and Expedited Studies

Renewal and Closure

Exempt and Expedited studies do not require annual review under federal code, but the IRB requests that researchers submit Renewals for these studies as well. To differentiate the federal requirements that apply to Full-Board-reviewed studies we use Administrative Check-ins for Exempt and Expedited studies. Researchers will receive notifications through Cayuse when the Administrative Check-in date is approaching. Renewal submissions take about 5 minutes to complete and help the IRB maintain an
accurate record of active studies at UNI.

If you have completed your research, you can submit a closure. Once you close the project you no longer need to submit administrative check-ins or renewals. You should not close a research project until you have completed recruitment, all interactions with or observations of human subjects, and analysis of identifiable data. If you continue to analyze data, but it has been fully de-identified, you can close the project.

Administrative Closure

Exempt and Expedited studies that have not had any activity in Cayuse for more than three years are subject to Administrative Closure. The Office of Research and Sponsored Programs will periodically purge old studies. We will first email primary contacts and PIs to notify them of our intent to administratively close a study at least 30 days prior to initiating closure. If we receive no response, we will finalize the
Administrative Closure. At that point, the research activity identified in the IRB application is no longer authorized under UNI’s IRB. Researchers will be required to submit a new application if they wish to resume the research activity.