The FDA recently issued a final Guidance titled, “IRB Continuing Review after Clinical Investigation Approval.” The purpose of the Guidance is “to assist institutional review boards (IRBs) … by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations.” 

As the Guidance notes, an IRB’s work is not done when it approves a clinical trial. Rather, FDA regulations require an IRB to have written plans for reviewing clinical trials “at intervals appropriate to the degree of risk, but not less than once a year.” This Guidance contains detailed recommendations and requirements relevant to that continuing review, and cannot be easily summarized. The following list of the topics covered by the Guidance is adapted from its table of contents and provides a good sense of its scope:

• Key Topics to Consider During Continuing Review
  •  Risk Assessment
  • Adequacy of Process for Obtaining Informed Consent
  • Local Issues
  • Trial Progress
• When Expedited Review Procedures May Be Used for Continuing Review
  • Expedited Review Category (8)
  • Expedited Review Category (9)
• Frequency of Continuing Review
• Determining Continuing Review Dates
• Communicating the IRB's Continuing Review Determination
• Lapse, Suspension, or Termination of IRB Approval of Research

Those interested in more details are advised to consult the Guidance, a pdf copy of which is available here.