All research protocols, once approved by the FUIRB, must be evaluated a minimum of once annually from the day of approval. Research protocols may be evaluated more often as dictated by the degree of risk associated with a specific protocol and with the populations being used as subjects in the study. If the project is ongoing, the investigator must submit a continuing progress report for review and approval prior to the anniversary of the prior approval (FUIRB Form A). Studies that do not have continued approval certified within 12 months of initial approval must be suspended immediately. The responsibility of the continuing review is that of the investigator.
The progress report serves to inform the FUIRB of the status of the project. FUIRB review and approval of the progress report extends the approval of the project for another period of time, up to 12 months (to be determined by the FUIRB). As part of the progress report, the investigator is required to incorporate the original protocol and modifications to the study during the previous 12 months (or less as determined by the FUIRB). The progress report must be on department letterhead and give a brief summary of the findings along with the reasoning behind any modifications.
Should the IRB approval lapse and the study is still going on, the study would no longer be eligible for the continuing review process and a new protocol must be submitted. Recruitment of participants and all other study procedures must cease until IRB approval is once again in place.
Renewal: Researchers who intend to resume an unaltered and previously approved investigation, in which IRB approval has expired, may submit a renewal request, if the research is being resumed within three-months of date of IRB expiration. A renewal request requires completion of FUIRB Form A, a brief summary of findings on department letterhead and submission of a copy of the original FUIRB approval notification. The responsibility of the renewal is that of the investigator.