Making changes or updates to a study

• For updates involving a Continuing Review on an Approved Expedited or Full Board study, watch the Creating a Continuing Review video or read the Creating a Continuing Review guide.
• To make changes to Exempt studies
  • In general, investigators are not required to submit changes to an exempt study unless it is believed the changes will increase the risk to participants.
  • Examples that may substantially change the focus of the research study include: a change in hypothesis, study design, adding or changing an incentive, or adding a new study population. If the study is modified to add additional sites for the research, note that you may not begin the research at those sites until you receive the appropriate approvals/permissions from the sites.
  • Contact the IRB Office at researchintegrity@fau.edu if you have any questions about whether a change must be submitted for IRB review and approval.
• To make changes to Expedited or Full Board Studies
  • Watch the Creating an Amendment video or read the Creating an Amendment guide
• For updates to study personnel
  • Use Form 116, “Non-Key Study Personnel”to track changes and submit the form the next time you submit an amendment with a change to the protocol. For more information visit Questions about Using IRB Novelution.