IRB: Amendments / Modifications to Protocols

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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". Select "Amendment / Modification" as the submission type.
  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 the amendment involves the addition of any new faculty / student collaborators, click "Share this Project" to provide signature access to the amendment package to the new collaborators.
  7. Click "Sign this Package" to indicate that all necessary application materials have been uploaded to the IRBNet package. You will be asked to indicate your role at this time. Only faculty eligible to serve as Principal Investigator should select the "Principal Investigator" role. All students and other personnel should choose a different role from the list. All personnel whom you have shared the package with must also log in to IRBNet and sign the amendment package.
  8. Once ALL research team members have individually signed the package in IRBNet, click "Submit this Package". Be sure to select "Lehigh University IRB" as the reviewing board. Once the package has been submitted, the Research Integrity office 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