Continuing Review (Renewal)

IRBs are required to review research protocols no less than once per year except for in the following circumstances.  Under the New Rule research protocols that meet one of the following may not be required to submit for annual continuing review after July 19, 2018:

  • Research eligible for expedited review,
  • Research that is limited to data analysis of indentifiable private information or identifiable biospecimens, or
  • Research that accesses follow-up clinical data that subjects undergo as a part of their clinical care

Note that release from the requirement for Continuing Review does not release the Investigator from other regulatory requirements such as submitting modifications and amendments for review and approval prior to implementation and submission of reportable events.  Failure to do so may result in a finding of non-compliance.  Investigators are also required to submit a Termination Report upon completion of the study. 

Determining the Need for Continuing Review

Note that the IRB will make the final determination on the need for ongoing Continuing Review

CR = continuing review
Status Funding Source Risk Level Action
Ongoing Federal or Non-Federal Minimal / Expedited Release from CR
Ongoing Federal or Non-Federal Greater than Minimal Annual CR
Data Analysis Only - Identifiable Data or Specimens Federal or Non-Federal Minimal Release from CR
Data Analysis Only - Deidentified Data (not including specimens) Federal or Non-Federal Minimal Close Study
Analysis Only - deidentified specimens Federal or Non-Federal Minimal Release from CR
Long Term Follow Up Federal or Non-Federal --- Release from CR

Protocols eligible for release from Continuing Review must be granted the release unless a valid reason to renew is documented by the IRB.  Issues that may prohibit release from Continuing Review include but are not limited to the following situations:

  • Require additional regulatory or ancillary oversight (e.g. RDRC, COI)
  • FDA Regulated
  • Include international or non-local sites
  • New findings require additional oversight
  • History of non-compliance