Amendments

Definition

• Amendments relate to changes to the study protocol, IRB application, or contract after obtaining the initial IRB approval or contract signature, such as change of study staff, the addition of interventions, or a change in the study budget.

Policies/guidelines

• Investigators must seek Institutional Review Board (IRB) approval before making changes to the approved research protocol via an amendment. If you are working on a study that is utilizing a central IRB, the sponsor or prime recipient may submit the change to the central IRB. Changes must be approved by the central IRB prior to submitting locally.
• The modifications may not be implemented until the IRB has reviewed and approved the proposed changes.
  • When the modification involves the addition of investigators or study personnel, the investigators/personnel may not assume any study responsibilities involving human participants or their identifiable data until the IRB has approved their participation.
• If you are conducting an investigator-initiated Investigational New Drug or Investigational Device Exemption study, check with your Food and Drug Administration contact to determine if they also need to approve the protocol change.
• If the changes impact the study budget, contact the Office of Clinical Trials to re-negotiate the budget.

Training

• Contact the Human Research Office at (601) 984-2815 for more information on submitting amendments.