Renewals

URIRB requires that all research protocols be renewed or closed within one year of their initial approval date. Researchers performing research that extends 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.

In most cases, investigators should submit:

• The Renewal/Closure Form
• The original IRB Form (with any modifications to the protocol highlighted)
• The consent form currently in use in the project
• Any other necessary supporting documents, such as survey items, debriefing statement, recruitment message, and so on

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 limited or 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 limited or expedited review process.