IRB: Ethics & Human Research

Improving Rates of Lapse in IRB Continuing Reviews: The Department of Veterans Affairs’ Experience

Ten Veterans Affairs’ research facilities with institutional review board (IRB) continuing review lapse rates that were higher than the Veterans Affairs’ national average for three consecutive years, from 2011-2013, developed and implemented remedial action plans to improve their IRB continuing review lapse rates. Eight of these 10 facilities showed a markedly improved lapse rate after implementing remedial action plans. The other two facilities failed to fully implement their remedial action plans and did not show any improvement. Remedial measures that were considered to be most effective in improving these lapse rates included tracking expiration dates of IRB approval, notifying investigators at least 60 days prior to approval expiration, investigator training and education, follow-up with investigators to ensure the continuing review application was submitted in time for IRB review, and stopping all research activities for a study when a lapse occurs.