Protocol Exception / Deviation

 

Whenever the IRB approved protocol is not adhered to, for whatever reason, this information needs to be reported on the Exception/Deviation Form. Protocol Exception means the enrollment of a research subject in a protocol that fails to meet protocol inclusion criteria or a person who should NOT have been enrolled based on protocol exclusion criteria.

Examples:

• Enrolling a 70-year-old patient when the inclusion criteria specify 25-65 years of age.
• Enrolling a patient with serious disease that is precluded from participation in the protocol exclusion criteria.

Protocol Deviation means a departure from the protocol for a research subject once that subject has actually been satisfactorily enrolled. There is a non-adherence to the IRB approved study procedures, which do not involve inclusion/exclusion criteria.

Examples:

• Enrolling a greater number of subjects than the protocol states (i.e., enrolling 125 subjects when the protocol was approved for 100 subjects).
• Drawing a 13th tube of blood from a subject where the protocol specifies that 12 samples will be collected for the study.
• Instituting a procedure on one or more enrolled subjects that is not specified in the protocol.
• Absence of consent or alteration of the consent process without prior written IRB approval.
• Complaint from a research subject that cannot be resolved by the study staff that is directly related to activities described in the protocol and requires corrective action by the study staff.