Protocol and Amendment Review

Administrative Review

• Training/ OHS Review: A member of the IACUC Office team checks the names of the individuals named in the application against the list of names of individuals who have completed the required animal care and use training. The date of completion of animal care training must be within three years of the date of receipt of the submission.   The names of individuals listed on the protocol must also be checked against the names of faculty, students and personnel who are in compliance with enrollment in the Occupational Health and Safety program. If listed individuals are not in compliance with the training and/or Occupational Health and Safety program requirements, the IACUC Office sends a notification to the applicant (Principal Investigator – PI) regarding the requirements, informing them that IACUC approval will be withheld until the requirements are met. Notices on how to meet the requirements are sent to applicable personnel.
• The IACUC Office conducts an administrative review of the application or amendment to pick up gross omissions before the submission continues within the pre-review process. In cases where need for significant revision is apparent, the IACUC Office may recommend that the PI seek immediate assistance from a Committee member in revising the application or amendment.
• The IACUC Office indicates whether or not a protocol submission would be subject to USDA reporting, using the definition of “animal” included in 9 CFR 1.1. The designation is subject to change during the review process.  This designation is not final until the protocol is approved.  This designation is noted in the master record of the protocol in the RED system.

Pre-Review: Vet Review/ IACUC Member Pre-review

To facilitate the PI’s submission of the protocol or amendment, the IACUC Office first assigns a veterinary and IACUC member pre-reviewer to perform an additional level of pre-review prior to distribution to the larger committee by designated member review or Full committee review. The veterinary reviewer will conduct their review with regard to veterinary issues. The veterinarian will usually be a current IACUC member; however, other veterinary reviewers may be utilized as consultants. The IACUC member who conducts the pre-review will also serve as the designated reviewer to provide final approval if full committee review is not requested.  Initial contact with the PI for any review should occur within 5 working days of receipt of the review assignment.

Designated Member Review

The NC State IACUC conducts committee reviews of all Category C and D protocols under the Designated Member Review process

Category C and D Protocols

• If the pre-reviewers are satisfied that the application requires no further revision, they will recommend that the protocol or amendment be sent to all other members of the committee for Designated Member Review notification
• Members are notified by email that they have three (3) working days to review the submission and any member of the IACUC may request full committee review of those research projects.
• If full committee review is not requested, at least one member of the IACUC, designated by the Chairperson and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval) or request full committee review of those research projects.
• At any time during the Designated Member Review period, committee members may forward comments with requests for minor revisions (i.e. revisions that would not require discussion at a convened quorum). Any modifications required for approval are sent to the PI or their designee to address and return to the IACUC members for final review and approval by the designated member.
• Expedited Reviews: At times, the IACUC Office, in consultation with the IACUC Chair, will approve investigator requests for expedited review. The procedures are the same as above, with one exception. The committee will be allowed a shorter time to respond during Designated Member Review (1-4 working days), subject to determination by the Chair (or in their stead, the First or Second Vice-Chair) and the IACUC Director (or in their stead, an IACUC Coordinator).
• If Full Committee Review (discussion at a meeting) is requested during any part of the review process by the reviewers, the IACUC office is notified of the concerns raised, the PI is notified and the item is placed on the agenda for discussion at the next meeting.

Full Committee Review

Category E Protocols

• The IACUC Office should advise the PI that, in accordance with NC State IACUC guidelines, all protocols and amendments involving Category E animal use must be presented for discussion at a convened quorum (Full Committee Review). The IACUC Office will inform PIs that revisions to the protocol or amendment should be completed at least one week prior to the scheduled meeting, to allow all members adequate time to review the protocol or amendment. Otherwise, the protocol or amendment will be considered at a future convened quorum.
• Amendments to approved Category E protocols will only require discussion at a convened quorum if additional Category E animal use procedures are proposed.
• When the pre-reviewers are satisfied that the protocol or amendment requires no further revision, they will recommend that the item be placed on the agenda for the next meeting.
• Protocols and amendments involving Category E animal use, those for which the vet reviewer or Designated Member Reviewer have requested discussion at the next meeting, and any other protocols that have been flagged for discussion by any voting member of the committee during Designated Member Review are placed on the agenda for discussion at the next meeting.

Outcomes of Full Committee Review

• Item approved as submitted: Once a new protocol or amendment is approved, the IACUC staff notifies the PI. A copy of the approved protocol or amendment is forwarded to the animal facility identified in the protocol as the location/site of the animal use. The University Attending Veterinarian is copied on all approval notices.
• Requested modifications to secure approval: In such a situation, the IACUC may take the following actions:
  • If all members of the IACUC are present at a meeting, the committee may vote to require modifications to secure approval and have the revised research protocol reviewed and approved by designated member review, or returned for FCR at a convened meeting.
  • If all members of the IACUC are not present at a meeting, the committee may use DMR subsequent to FCR according to the following stipulation: All IACUC members agree in advance in writing that the quorum of members present at a convened meeting may decide by unanimous vote to use DMR subsequent to FCR when modification is needed to secure approval. However, any member of the IACUC may, at any time, request to see the revised protocol and/or request FCR of the protocol. The approval date is the date that the designated member(s) approve the protocol.
  • Withhold approval: If a protocol application or amendment is not approved during Full Committee Review, the IACUC Office contacts the investigator in writing regarding the IACUC’s decision. The communication includes the IACUC’s decision and informs the applicant regarding recommended modifications required to secure IACUC approval. The investigator may respond either in writing or in person at a convened quorum of the IACUC.