Amendment to approved research

All research applications must be submitted to the IRB through IRBNet, an externally-hosted software product. All IRB forms must be obtained from the IRBNet Forms and Templates library.

The IRB must review and approve all changes to previously approved research prior to implementing the change. Amendments to Human Research include any change from what was previously approved, including but not limited to: title, key personnel, study procedures, recruitment text or locations, data collection measures, or eligibility criteria.

If you are adding or removing researchers to your project, please see the Amendment of Project Personnel section below.

If you received an approval with conditions, create a new package within your conditionally-approved project and submit the condition requirements.

Amendment of research submission

To submit an amendment you will need to create a new package within your currently approved project.

All amendments require the following:

• Complete and upload the Amendment Request form.
• Any documents that your amendment affects. (Examples: Informed Consent form, recruitment flyer, project narrative, etc.) When revising documents, please use tracked changes to help facilitate the review process. View the tutorial on using tracked changes in Word.
• The PI must sign the package (Tip: Student projects must be signed by the faculty advisor as well as by the student PI.)
• Submit the package by clicking the “Submit” button in IRBNet. Select “Amendment/Modification” from the “Submission Type” dropdown options.

See Amending Approved Research for guidance.

Amendment of project personnel submission

To submit an amendment you will need to create a new package new package within your currently approved project.

All amendments of project personnel require the following:

• Complete and upload the Amendment of Project Personnel.
• Complete and upload the List of Project Personnel.
• The PI must sign the package.. (Tip: Student projects must be signed by the faculty advisor as well as by the student PI.)
• Submit the package by clicking the “Submit” button in IRBNet. Select “Amendment/Modification” from the “Submission Type” dropdown options.

Additional requirements:

• A CV or biosketch for the PI, all CO-PIs, Co-Investigators, and/or faculty advisor