An updated version of the University’s SOP for protocol deviations will be released in December 2023 for immediate implementation. Important changes are being made in response to recent FDA citations of investigators for deviating from the study procedures as established in the IRB-approved protocol.
The updated SOP will help to protect University of Utah investigators by requiring that any changes to study procedures must first be approved by the IRB through a full protocol amendment. This requirement for prior IRB-approval applies even when there is correspondence from the sponsor through a protocol administrative letter (or equivalent). However, the requirement for prior IRB-approval does not apply to deviations made for participant safety.
The full announcement is available on the SOP webpage: here.