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  1. A modification request may be submitted through IRBIS.  The change could be something as simple as adding a research team member (i.e. adding Research Assistant or Co-investigator) or more significant such as changing the study procedures or changes to documents used with the participants (consent forms, questionnaires, recruitment materials, etc.).  In all cases, you must have IRB approval of the change BEFORE implementing the change.

  2. As part of the modification process, carefully review your approved consent document and/or other approved study materials and makes updates as needed.  The revised consent and study materials must be uploaded to IRBIS as part of the modification request.  

  3. If the changes to your study are urgent without which participants are at risk, contact the Office of Research Compliance for assistance.