Health Sciences IRB Chair

Protocol "Exceptions" and "Deviations"

At its March 31, 2003 meeting, the Health Sciences IRB adopted guidelines to assist researchers in determining when deviations or exceptions to approved clinical research protocols required submission to the IRB as a change of protocol. The guidance follows:

The Health Sciences IRB recognizes that investigators frequently enroll subjects, usually with permission from the study sponsor, who may deviate from the eligibility criteria in a minor way or who may have a study visit outside the timeframe required by the study. Consequently, the Health Sciences IRB determined that if the investigator and sponsor (when applicable) determine that the protocol "exception" or "deviation" does not present a significant safety risk to the subject or potential subject then the "exception" or "deviation" is not required to be reported to the Health Sciences IRB.