Amendments & Reporting Adverse Events

Once the IRB has approved a project, it must be carried out as planned. However, in some cases it is necessary to make a change to an approved project. Projects that are verified as Exempt status may be amended without notifying the IRB if the changes do not substantially alter the nature of the project.

Any changes to research approved through Expedited or Full review must be approved by the IRB as an amendment to the application prior to enacting the changes. For example, changes to members of the research team, subject population, data collection methods, consent documents or recruitment scripts, and location must be approved as amendments.

To make an amendment to an approved application, write an explanation of the changes and why they are needed and if these changes present new risks to subjects. Upload the document explaining the changes to the Mentor application using the link at the bottom of the screen for “Amendments.” The IRB will review the document and inform you if further documentation, such as a revised application form or consent form, are needed.

When an adverse event occurs it must be reported to the IRB immediately. To do this write an explanation of the event and the risks it presents to subjects and upload the report to the Mentor application using the link at the bottom of the screen.