UUSOP-07: Deviations and Reporting

The FDA has recently been observed to issue 483 letters to investigators that have deviated from the IRB-approved protocol with what is referred to as "sponsor approval." Sponsor approval is not an exemption from deviation. The FDA expects investigators to obtain IRB approval for alternate procedures before implementation.

In order to protect the Institution and University investigators, UUSOP-07 will be updated to require any departure from the IRB-Approved protocol first be sent to the IRB for review and approval prior to enactment.

This will require investigators and study teams to be thoughtful when reviewing protocols. If there are areas of the protocol that are unfeasible or unnecessarily limiting, such as eligibility criteria or treatment parameters, efforts should be made to correct them before enrolling participants.

In addition, study teams are required to request an amended protocol from the sponsor for any changes that are only included in protocol administrative letters (or equivalent). Records of these requests to the sponsor must be filed in the study's regulatory binder.

Strict adherence to the IRB-approved protocol is the most effective way to ensure research integrity and compliance, and to eliminate the risks associated with FDA investigation.