Continuation

Not more than one year from the date of IRB action (not from the date of project initiation), previously approved and on-going protocols must be submitted for renewal. The research investigator is responsible for seeing that the continuing review approval is completed before the deadline. There is no grace period, the approval will have lapsed and research cannot continue.

Routine projects of minimal risk will be reviewed at 12-months, however, 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

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