Once approved, applications receiving either an expedited or full-committee review must maintain their approval status through data collection and analysis, on a yearly basis. For research projects lasting one year or less, this is not an issue since the research will be completed before the approval status expires. However, for those projects that will continue beyond a year, it is necessary to submit a Continuing Review Report so as to keep the approval status current.
Two months prior to expiration, a Continuing Review Report must be submitted to the Research and Strategic Partnerships. This form is available here, and hard-copies are available in RSP as well. A copy of the current consent form being used must be submitted along with the report, even if it is already on file with the HSRRC.
The review process and any revisions must be completed and re-approved before the approval status expires. If the approval status does expire, the HSRRC will terminate the study immediately according to the DHHS code of federal regulations (21 CFR 56.103 (a)). To continue the research or enroll new subjects after the expiration date, HSRRC policy requires the investigator to re-submit the protocol as a new application for a completely new review. This process is very time consuming for the committee and the investigator. Therefore, it is imperative that the Continuing Review Report be submitted on time.