Amendments

Learn more about amendments

Adding or removing IU affiliated investigators

Key personnel update

During the course of your study you may need to add or remove an IU affiliated co-investigator or other key personnel by submitting an amendment in the KC IRB system. The following requirements must be met prior to any new personnel participating in the previously approved project:

  • Completion of the required CITI training modules
  • Submission of an annual Conflict of Interest disclosure form
  • Approval notification received from the HSO

Research (non-key) personnel update

The Human Subjects Office must be notified of the addition of any non-key personnel but prior approval is not required, and the research personnel may begin work on the project as soon as the notification has been received. The following conditions apply:

  • Non-key personnel who are directly interacting with subjects must complete the required CITI training modules
  • Non-key personnel are not required to complete the annual conflict of interest disclosure
  • No forms or attachments may be revised with a non-key personnel update; an amendment must be submitted instead
Please review the instructions for adding non-key personnel

Investigator Brochure updates

Study teams must submit the Investigator Brochure (IB) at the time of initial IRB review and with each subsequent renewal. The IU IRBs do not typically review updates to the IB, unless these changes affect the risk profile. In these cases, the revised IB should be included with the amendment as supporting documentation only.

Filing an amendment in KC IRB

To file an amendment to a previously approved research project, use IU’s KC IRB system:

  • Complete the amendment questionnaire in KC IRB
  • Attach supporting documentation e.g., study forms, documents, or questionnaires affected by the amendment.
  • Once you have uploaded your amendment in the KC IRB system, you will be contacted by the Human Subjects Office if additional information is needed. When you receive approval, you may begin using the amended materials.