An approved animal care and use protocol is required to use any living vertebrate animals for research or instructional purposes.
Animal Care and Use Protocols are approved for a period of 3 years. This time cannot be extended. If work on a protocol is to go beyond the three-year point, a new protocol must be submitted and approved before the first protocols expires. If a new protocol has not been approved to continue by the time the protocol expires, all work on the project must stop and the animals will either have to be transferred to another protocol or euthanized. It is a violation of institutional policy and our OLAW assurance for a researcher to perform procedures on animals on an expired protocol. Also, if a PI performs work on these animals and it is federally funded, the IACUC may be required to inform the funding agency and OLAW of the violation. This reporting will be done by the Institutional Official with the support of the IACUC
Completion and e-Submission of a Animal Care and Use Protocol form and Animal Hazardous Material Addendum(If necessary): All protocols and Animal Hazardous Materials Addenda (AHA) must be submitted on the most up to date Form. All submissions to the IACUC must be submitted electronically via email to [email protected]. Electronic forms allow the PI and the IACUC to easily modify any part of the protocol during the review process. The most updated forms can be found under the Forms tab. It is important that the PI carefully read and answers each question on the protocol form. Incomplete answers may result in the protocol not being approved. If assistance is needed with the protocol form, the PI may contact the DLAM office (x3958 or email [email protected]). The Attending Veterinarian is available to discuss species/animal models, methodologies, anesthesia, analgesia and euthanasia to ensure that the procedures described meet with current veterinary standards. Contact the DLAM for contact information.
- Pre-Review (Optional): For new PI’s and researchers, we suggest that they have their new protocol pre-reviewed. The protocol will be reviewed and we will provide suggestions on preventing common mistakes and help with formatting of information and content. The pre-review does not guarantee approval, however, it may limit the number of clarifications that will be requested during an IACUC review. To request a pre-review, email a copy of your protocol to the Director of DLAM (at least 14 days before a scheduled NU-IACUC meeting). The protocol will be returned with appended feedback (i.e., comments, questions, and suggestions) via the Review features of Microsoft Word. The Pre-Review does not guarantee the protocol will approved.
- Protocol Signature Page: The signature page is to be completed as instructed on the form at protocol submission (fill in name)
- Submission of Protocol: When the protocol and AHA (if required) are ready to be submitted to the IACUC, the investigator must be submit the completed documents electronically, via email to [email protected]. The items will be then sent to the full IACUC for an expedited reveiw vote, typically every Tuesday. The committee will either approve the protocol be sent for Designated Member Review (DMR) or be sent for Full Committee Review (FCR) at a convened IACUC meeting. All meeting dates and submission deadlines are posted on the DLAM/IACUC Meeting Schedule page. If the committee votes to send the protocol for a FCR, then the the Chair will schedule a meeting to review and discuss the protocol.
- Protocol Review and Approval Process: When a protocol is approved for DMR, a subcommittee of the IACUC called the DRC (Designated Review Committee) will review the protocol and send questions to the PI for modifications or clarifications. Once those modifications/clarifications have been met, the protocol can be approved. If a protocol is sent for FCR, the Committee at the scheduled NU-IACUC meeting will review each protocol. The NU-IACUC may approve or not approve a protocol contingent upon modifications or clarifications. After review of the protocol at a fully convened meeting, the NU-IACUC will decide on one of the following actions:
- Approved: the protocol is approved as is and no clarifications are necessary.
- Non-Substantive with Re-Review by the DRC (Designated Review Committee): there are minor clarifications that need to be made and those changes can be reviewed and approved by the DRC. The DRC can give final approval to protocols reviewed by the NU-IACUC that were approved with either a “Non-Substantive changes requiring re-reviews by the DRC”. The DRC will review the investigator’s responses to the NU-IACUC’s requests for clarification and/or changes. When all listed requirements have been met, the DRC will give full approval. If these demands have not been met, the protocol will not be approved by the DRC. Protocols may be sent back to the Committee if the DRC feels the protocol has additional problems not recognized during the original review process.
- Substantive: requires significant changes that need to be re-reviewed by the Full IACUC at the next meeting.
- Disapproved: the protocol was not considered.
- For protocols requiring Non-Substantive changes, all requested clarifications and required modifications are emailed to the principal investigator along with the Word document that was reviewed and updated by the IACUC. The PI will make all required changes and clarifications directly in the protocol using the Track Changes and send the modified Word Document electronically to the DLAM Director at [email protected] to be reviewed by the DRC. The DRC will often ask for further clarifications using Track Changes and this correspondence will be done via email. Once the protocol has been approved by the DRC, The IACUC Office will email the PI the final copy of the document with an approval email.
- After approval of the protocols, the IACUC administrative office will send an approval email to the PI. We do not generate Protocol Approval Letters unless they are needed in support of a grant.
- If this protocol is to be used for the submission with a Federal grant, the PI must submit a copy of the Vertebrate Animal Section (VAS) of the grant and complete and submit the NU-IACUC Protocol/Grant Congruency Verification Form. The IACUC is required to confirm congruency by ensuring all animal work on the grant is covered by an approved animal care and use protocol. Basically what we do here is compare the VAS to the protocol and ensure the protocol covers the work in the VAS. If congruent, the IACUC will generate an approval letter with grant information in the letter. Please allow 1-2 weeks for this request.