All amendments and/or modifications to previously approved protocols must be reviewed and approved by the IRB prior to implementation except when necessary to eliminate apparent immediate hazards to the human subjects.

Submitting Amendments / Modifications via IRBNet:

  1. Log in to irbnet.org.
  2. Locate the project associated with the amendment you wish to submit. All previous IRBNet submissions can be viewed under "My Projects". Click the project title to enter the project. If you know the IRBNet ID for the project, you may also search using this ID number.
  3. Amendments / modifications are submitted by creating a new "package" within the existing IRBNet project. To create the amendment package, click "Create a New Package". 
  4. Click "Designer" to access the Amendment Modification form. Click "Download" to save this form to your local computer. (Note: the amendment form and other supplemental materials can also be found under the "Forms and Templates" menu option.)
  5. Once you have completed the amendment form in full, click "Attach New Document" to upload the completed amendment form as part of your submission package. Repeat to add all necessary new and/or modified supplemental documents (e.g. consent form(s), ethics training completion certificates, study materials, etc.)
  6. If you are including new personnel in the amendment who are students or staff, include copies of each person’s CITI training certificate. The PI may also choose to share the IRBNet package with new personnel (this is optional). If the PI wishes to add new faculty / student collaborators, click "Share this Project" to provide signature access to the new collaborators. 
  7. As of April 27, 2026, only PIs are required to sign the package, and all other personnel are no longer required to sign the IRBNet submission. PIs may add other personnel and request for them to sign the package at their discretion.
    The PI must click "Sign this Package" to indicate that all necessary application materials have been uploaded to the IRBNet package. Only faculty eligible to serve as Principal Investigator may fulfill the "Principal Investigator" role. All students and other personnel with whom the package was shared may also log in to IRBNet and sign the amendment package.
  8. Click "Submit this Package". Select "Lehigh University IRB" as the reviewing board. Select "Amendment / Modification" as the submission type. Once the package has been submitted, the Office of Research Integrity will conduct a pre-review of your amendment materials and notify you if any changes or additional information is necessary prior to IRB review.

Tutorial: Submitting Subsequent Packages and other Advanced Topics - update and revise project documents for resubmission; submit subsequent packages such as responses, amendment, or continuing reviews; review and manage messages, alerts, and reminders.
Tutorial: Additional Information on Submitting Subsequent Packages