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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.