Institutional Review Board (IRB) and Human Subjects Protection

Protocol Change Request

Investigators may request approval to make changes (amendments) in various aspects of a project. All changes must be approved by the IRB prior to implementation. Amendments include but are not limited to: changes in experimental design, insertion of new information, correction of errors in text, change in primary investigator, change in study duration, change in numbers of subjects, or number of locations (site). A written request must be submitted using the Protocol Change Request. Upon completion of review (generally within 1 week of the submission), an approval notification will be sent to the primary investigator.