Study Renewal (Continuing Review) and Project Closure
All Expedited and Full Board studies must be reviewed at least annually by the IRB. Investigators are also required to close the project out with the IRB when the study ends. Exempt studies are exempt from these requirements, although approval is required before modifications are made for all studies, including Exempt projects.
The purpose of continuing review is to determine whether the risk/benefit ratio previously assessed has changed, to ensure that the measures taken to safeguard participants are adequate, that the approved IRB application/protocol is being followed, and that the project reflects any changes that have been made in the regulations for human subjects research since the last approval. In the event of Project Closure, the form provides a final report of how the study progressed and whether or not any problems arose.
Continuing Review of Ongoing Research
Continuing reviews are performed by the IRB Chair or one or more experienced reviewers designated by the IRB chairperson from among the IRB members (45 CFR 46.110(b)). The IRB chairperson or IRB members designated by the chairperson can approve or require modification in (to secure approval of) research, but may not disapprove research using the expedited procedures (45 CFR 46.110(b)). Disapproval of continuing research can only occur after review by the IRB at a convened meeting. All IRB members must be advised of research that has been approved under an expedited review procedure (45 CFR 46.100(c)).
Form and Attachments
The form for requesting continuing review and for closing out a project is the same, posted on the IRB forms page. The Continuing Review/Closure form and any required attachments must be submitted prior to the expiration date designated at last review. A current copy of all assent and consent forms must be attached for all Active studies (except those in data analysis only), even if no changes have been made. The form may be submitted at any point prior to expiration.
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 is de-identified.
Federal regulations require that the IRB conduct ongoing reviews of all non-Exempt protocols at intervals appropriate to the degree of risk, but not less than once per year. The interval is set for each protocol. Most 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 Expedited approval date or in the case of Full Board studies, the date of the IRB meeting at which the research was approved (with or without conditions) even though the research activities may not begin until after the IRB has given final approval. 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 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 primary 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 printed in a formal letter of approval sent to the investigator. Investigators will be informed if a continuing review is required and that s/he is responsible for submitting a Continuing Review form in sufficient time for review to occur prior to the study’s expiration date. For expedited studies, Continuing Review forms should typically be submitted 2 weeks prior to the expiration date. For full board studies, continuing review requests should be in to the IRB office at least 45-60 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 form early 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 non-exempt studies, a Continuing Review/Closure form 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 form 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 and form, a second reminder email is sent to the same individual(s), 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 him or her that no further research is permissible without a new review.
It is the investigator’s responsibility to ensure that his or her research is submitted for review in time for continuing approval. If the continuing review form is not received by the IRB office at least by the study expiration date, the study approval automatically expires and new application for review will be required in order to continue the study.
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 at that point 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.
Review Process for Active Projects
For most projects that require ongoing approval, the reviewer will receive a copy of the past protocol and modifications from the study file, as well as the current Continuing Review/Closure form and materials. (For active projects in which no participants have been enrolled, or participant enrollment has been completed, reviewers may simply choose to review the Continuing form and materials without examining the overall file.) During the review, the reviewer may email any questions or concerns to the investigator. If it is an expedited study, the reviewer may simply approve the study for continuation by sending an email to the investigator, which will be followed by a more formal letter of approval from the IRB office. If the study required full board review, one member of the IRB will receive all past materials and 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 invited but not required to attend the meeting as well. Full board 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.
Submitting the Continuing Review/Closure form prior to the expiration date is not optional. As noted above, investigators are required to return the form even if the study is completed and renewal is not needed. The form serves both purposes.
Investigators may return the Continuing Review/Closure form at whatever point the project is complete, rather than waiting until the end of the approval period to close the study. 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 form will be forwarded to an IRB committee member for review, who will either share any questions or concerns s/he 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 without further communication with the investigator.