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Renewals

By law, an IRB approval can be effective for no more than one year.  IRB "continuing review" must take place "not less than once per year." Researchers performing research that extents beyond one year of the date of IRB approval will need to receive a new IRB approval, often just as if they were submitting a proposal for the first time.  In addition, researchers seeking renewals need to address various aspects regarding the status of their projects, including the number of participants, whether or not there were any unanticipated or adverse events, changes (if any) in the subject population, changes in the proposal (if any) and other matters.

The most efficient way of preparing a renewal will likely be through the use of the full proposal form.  The final section of the full proposal form addresses renewals and how to submit a proposal for renewal.

Extensive details on OHRP Guidance on Continuing Review and renewals is provided.

Any proposal renewal submitted for IRB review should be accompanied by an email that addresses the following points.

1. What was the date of the previous IRB approval (MM/DD/YY)?
    
2. How many participants have participated in this study?
____ Number consented in last IRB period
____ Number of withdrawals in the last IRB period
____ Total completed in the last IRB period
     
3.  Were there any unanticipated or adverse effects reported by participants?
____ No
____ Yes
If you answered Yes above, provide a detailed explanation of the unanticipated/adverse effect, including how many participants were affected.
   
4. Is the subject population unchanged?
____ Yes
____ No
If you answered No above, provide a detailed explanations of the changes.
    
5. Is the substance of the proposal changed in any way?
____ No
____ Yes
If you answered Yes above, provide an explanation of each change in the proposal in the email that accompanies the renewal and submit a pdf of the renewal application with all changes highlighted in yellow.

A complete list of documents that may be required by the IRB to approve a project renewal can be accessed in the OHRP document "Guidance on IRB Continuing Review of Research" in the section, Submission of Documents to the IRB.

The expedited review process can be used for the renewal of certain projects, in accordance with OHRP guidance.  It has been the practice of the University of Richmond IRB that minor changes may be made to any proposal using the expedited review process.  For example, the addition of a researcher to a proposal that poses more than minimal risk would be considered a minor change that could be approved using the expedited process.