Any new study must be submitted to and approved by the IRB before the Principal Investigator may begin the research
Any new study must be submitted to and approved by the IRB before the Principal Investigator may begin the research. Each new study must be submitted via www.irbplus.com.
After the IRB approves a study, an approval letter will be sent to the Principal Investigator. The approval letter states that the approval is for a specified period, never more than one year. The IRB may approve a study for less than one year at its discretion.
For the study to remain in active status, the PI must submit a periodic progress report, the “Continuing Review” within 60 days of the study expiration date.
The Continuing Review must be approved by the IRB no later than the date of expiration to remain in compliance with federal regulations. Federal regulations do not allow ANY grace period for renewal.
The IRB office will e-mail a Continuing Review notice approximately three months prior to the due date, a second notice approximately two months prior, and a final deadline notice approximately one month before the renewal deadline. If the PI fails to submit the appropriate renewal documentation, the study will be inactivated. The IRB must have time to review, meet, discuss and approve the study before the expiration date. If the expiration date of initial (or most recent) approval passes with no Continuing Review, the study will be administratively terminated. The IRB office will notify the PI by e-mail. All administrative terminations must be submitted to the appropriate Federal Regulatory Board (i.e. FDA, NIH and OHRP). The research study must stop when terminated by the IRB.
NOTE: The IRB must close any study for which the PI fails to complete a Continuing Review in a timely manner. No further research will be approved until all required reports are complete. The IRB must report to the FDA all items which have expired or administratively closed.
