All changes related to IRB approved research must be reviewed and approved by the IRB before the changes may be implemented. This includes, but is not limited to, changes in study staff, recruitment, procedures and funding.
Amendments involving minor changes that pose no more than minimal risk to subjects can be reviewed using expedited procedures. Proposed changes that might adversely affect the willingness of current participants to remain in the study or change the risk to benefit ratio for participants must be reviewed at a convened IRB meeting.
Investigators must complete an Amendment Form in eRA and submit the following documentation as applicable:
Amendments that may be reviewed using the expedited procedure may include:
Amendments that must be reviewed at a convened IRB meeting may include:
For step-by-step instructions for creating and submitting an Amendment submission refer to the eRA Amendment Submission Guide.