A more challenging environment for the ethical review and oversight of clinical trials in the US is behind new draft guidance from the Food and Drug Administration on how Institutional Review Boards (IRBs) should continue reviewing research once it is approved and underway.

Under existing FDA regulations, IRBs have to develop and follow written procedures for the continuing review of approved research “at intervals appropriate to the degree of risk, but not less than once a year”, the agency notes. For example, they must determine which clinical investigations require verification from sources other than the investigator that no material changes in the research have occurred since the previous IRB review.

However, points out the draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval, the FDA’s IRB regulations were first issued in 1981, “when the single investigator-single site study was the norm, and reporting requirements to IRBS were almost entirely and appropriately fulfilled by the investigator, who was in a position to know about all aspects of a study”.

Since then, the guidance adds, multi-site trials have become commonplace. As a result, while an individual investigator may inform the IRB about events at his/her particular site, the investigator and the IRB “may not generally be well informed about the far greater body of data reflecting events across all study sites”.

IRBS involved in multi-site studies may use co-operative review agreements or other mechanisms such as a centralised IRB review process to reduce or eliminate duplication of effort and to improve the consistency of the continuing review process, the draft guidance observes.

The full document, which is subject to a 60-day comment period, may be downloaded from the FDA’s website at: www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM197347.pdf.