IACUC: Submit a New Protocol / 4th Year Renewal

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Protocol applications must be submitted through IRBNet.org. IRBNet is secure, web-based, easy to use, and accessible from virtually any computer.

The IACUC recommends submitting applications at least six weeks in advance of the anticipated research start date. New protocols often will need adjustments before they are considered review-ready; please plan accordingly. 

Research with vertebrate animals may not be conducted without the advance approval of the IACUC.

Submitting a New Protocol via IRBNet:

  1. Log in to irbnet.org. (If you have not used the system before, you'll first need to register for an account as a new user.)
  2. Click "Create New Project" and fill in the required information for your study. (New protocols must be submitted by the Principal Investigator.)
  3. Click "Designer" to access the "New Studies / 4th Year Renewal" Protocol Application form. Click "Download" to save the application to your local computer. (Note: the application can also be found under the "Forms and Templates" menu option within IRBNet.)
  4. Once you have completed the application form in full, click "Attach New Document" to upload the completed application form as part of your submission package. Repeat to add any necessary supplemental documents, as applicable.
  5. Click "Share this Project" to provide access to the submission materials to your department chair. If your work involves animals being housed in the Central Animal Facility (CAF) and/or CAF space is being used for surgery, the project must also be shared with the CAF director. Sharing the project allows these individuals to digitally sign the submission, a required step prior to IACUC review of any submissions.
  6. 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. Additionally, all individuals with whom you have shared the package (e.g. department chair, CAF director) must each log in to IRBNet and sign the submission package.
  7. Once the Principal Investigator, your department chair (and the CAF director, as applicable) have each signed the package in IRBNet, click "Submit this Package". Be sure to select "Lehigh University IACUC" as the reviewing board. Once the package has been submitted, the Research Integrity office will conduct a pre-review of your submission materials and notify you if any changes or additional information is necessary prior to IACUC review.

Submitting a 4th Year (de novo) Renewal via IRBNet:

Every three years, investigators are required to submit a new application to maintain IACUC approval for their ongoing research. PHS Policy states that the IACUC must perform a "de novo" review every three years (we call this a 4th year renewal). The process is similar to submitting a new protocol for IACUC review, but differs in several important ways.

  1. Log in to irbnet.org.
  2. Locate the project for which you wish to submit a 4th Year Renewal. All previous IRBNet IACUC 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. 4th year renewals are submitted by creating a new "package" within the existing IRBNet project. To create the renewal package, click "Create a New Package". Select "Continuing Review / Progress Report" as the submission type.
  4. Click "Designer" to access the "New Studies / 4th Year Renewal" Protocol Application form. Click "Download" to save the application to your local computer. (Note: the application can also be found under the "Forms and Templates" menu option within IRBNet.)
  5. Prior to completing the 4th year renewal application, be sure to fully review all previously approved amendments/modifications; these approved changes must be incorporated in your 4th year renewal application. Any new changes should be included in the 4th year renewal application for IACUC review and approval. Once you have completed the application form in full, click "Attach New Document" to upload the completed application form as part of your submission package. Repeat to add any necessary supplemental documents, as applicable.
  6. 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. Additionally, all individuals with whom you have previously shared the package (e.g. department chair, CAF director) must each log in to IRBNet and sign the submission package.
  7. Once the Principal Investigator, your department chair (and the CAF director, as applicable) have each signed the package in IRBNet, click "Submit this Package". Be sure to select "Lehigh University IACUC" as the reviewing board. Once the package has been submitted, the Research Integrity office will conduct a pre-review of your submission materials and notify you if any changes or additional information is necessary prior to IACUC review.


Tutorial: New User Registration – registering for IRBNet. Each individual user must register and affiliate with Lehigh University.
Tutorial: New Project Submission - creating, designing, sharing, signing, and submitting new IRBNet Projects to the IACUC. 
Tutorial: Submitting Subsequent Packages – *creating, designing, sharing, signing, and submitting new Packages on existing IRBNet Projects. You must create a new Package each time you submit a response to Modifications Required to Secure Approval on an IACUC submission, a Modification/Amendment to an IACUC-approved protocol, or an annual Renewal (including 4th year Renewals) on an IACUC-approved protocol.
Tutorial: Signing IRBNet Packages – reviewing and signing IRBNet packages that have been shared with you.