Update March 16, 2020: The process outlined below for urgent Amendments is being temporarily suspended until further notice. IRBMED has published new procedures and a workflow diagram for time-sensitive and urgent modifications to active research. This is available here.
NOTE: In light of the COVID19 situation, IRBMED is currently in the process of modifying urgent amendment procedures.
Urgency is based solely on urgent health needs of one or more subjects.
Sometimes situations arise which, while they do not meet the magnitude to constitute "an apparent immediate hazard," they do require changing the research in some way on an urgent basis. The most common example occurs when a patient does not meet all the eligiblity criteria for entry into a study andthe patient would need to be enrolled on the study prior to the usual time amendment approvals take to receive IRB review and approval (on average, 3-4 weeks). Follow the steps below to request an urgent amendment review.