Continuing Review

Generally, no continuing review of approved research is required if the research project meets any of the following criteria:

• The research was deemed exempt, with or without limited IRB review.
• The research was approved using the expedited review procedure.
• The research has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable.
• The research has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.

The IRB has the authority to require continuing review of research that is normally exempt from continuing review. If the IRB requires continuing review of a project that meets one of the above criteria, the IRB will document this decision and the rationale for this decision.

Projects that do not meet any of the above criteria must undergo continuing review not more than one year from the date of IRB approval. The primary investigator is responsible for seeing that the continuing review process is completed before the deadline. There is no grace period. If continuing review is not completed, the approval will have lapsed and the research cannot continue.
Projects of moderate or high risk involving adult subjects and projects of greater than minimal risk involving minor subjects may at the discretion of the IRB be reviewed more frequently, commensurate with the risk involved. The experience of the investigators will also be considered. At the time of initial IRB approval, the IRB will notify the investigator of the level of risk and the approval period assigned to the project. The IRB may modify the level of risk and length of approval period following review of changes to a project or following continuing review of a project, as appropriate. The research investigator will be notified of any such modifications.

In addition to scheduled continuing reviews, the IRB may elect to review the data accumulated by the investigator(s) or interview both the investigative staff and research subjects. The IRB may designate an IRB member or independent consultant to verify that no material changes in a research project have occurred since the previous review. IRB may check on any project at any time to assure it is meeting IRB guidelines.

Submission Requirements

For projects previously approved by expedited or full board review, continuing review materials should be submitted at least one month prior to the expiration date keeping in mind the date scheduled for the next IRB convened meeting. The research investigator is responsible for submitting the following documents as attachments to an email message to IRB@drake.edu for continuing review.

• A completed Continuation/Termination Form
• A clean copy of the current consent/assent document, if subjects are still enrolled in the study
• If research subjects were enrolled in the last approval period, copies of assent/consent forms available for IRB review upon request.

Failure to complete and submit the continuing review form in the time stipulated will lead to corrective action resulting in the research project being closed. If this occurs, the research investigator will have to resubmit a new application for full board review and receive IRB approval for that submission before continuing the research.
Please contact the IRB with any questions or concerns
515-271-DIRB (3472)
irb@drake.edu

Please contact IRB staff with any questions or concerns
515-271-2850
irb@drake.edu