BACKGROUND

This Standard Operating Procedure (SOP) provides a detailed description of procedures for Full Committee Review (FCR) followed by the IACUC.

IACUC Procedure

Investigators submit new protocols and amendments ("submissions") via eProtocol.

• All protocols may be pre-reviewed by the IACUC office or a veterinarian prior to review by the IACUC. Protocols are then polled to determine if Designated Member Review (DMR) or FCR is appropriate for the submission.
• Amendments involving significant changes (see the Review of Significant Changes to Approved Protocols SOP) are polled to determine if DMR or FCR is appropriate for the submission.

Prior to the monthly meeting, at least one reviewer and a veterinarian are assigned to each FCR submission by the Chairperson (or designee). The submissions are provided to the full IACUC.

The reviewer(s) is responsible for reviewing the entire submission. All other members are expected to review each submission and provide comments if necessary.

Determinations

The IACUC reviews protocols and amendments per the Conducting IACUC Business During a Convened Meeting SOP. The submission will be placed in one of four categories based on the decision of the committee. They are:

• Recommended for Approval: The submission complies with all requirements of the Guide for the Care and Use of Laboratory Animals, PHS guidelines and USDA regulations and is written in such a way that only administrative questions or clarifications are required.
• Modifications Followed by DMR: The submission complies with all requirements of the Guide for the Care and Use of Laboratory Animals, PHS guidelines and USDA regulations, but is written in such a way that minor questions and/or clarifications must be resolved to secure approval. The committee members present at the meeting must decide by unanimous vote to use Designated Member Review (DMR) to review the submission after it has been modified.
• Tabled, Require FCR: The submission either does not comply with all requirements of the Guide for the Care and Use of Laboratory Animals, PHS guidelines or USDA regulations or is written in such a way that there are serious questions that must be resolved to secure approval. Subsequent approval must be decided by Full Committee Review at a convened meeting.
• Approval Withheld: The submission either does not comply with all requirements of the Guide for the Care and Use of Laboratory Animals, PHS guidelines or USDA regulations or the PI will not agree to comply with the IACUC's requirements.

Following the meeting

Investigators are notified as to the outcome of the submission review process and are provided with the questions and/or clarifications of the Committee. The categories are handled as follows:

• Recommended for Approval: The submission can be approved as soon as all administrative IACUC requirements have been completed (see "Final Approval Requirements" below). Principal Investigators who have submissions in this category will not receive an official letter from the office until Final Approval has been granted; however, a reminder as to what IACUC requirements are still outstanding will be sent to the PI.
• Modifications Followed by DMR: The submission must be revised per the Committee's questions and/or requests for clarifications and resubmitted for review by Designated Member Review (DMR) as assigned by the Chairperson (or designee). The reviewer will confirm that all questions and/or requests for clarification have been resolved. Once the reviewer is satisfied with the revision, the submission will be recommended for approval. The submission does not need to be submitted to another convened meeting for FCR unless the reviewer determines that the changes made by the investigator constitute a substantial alteration to the protocol or are unacceptable and cannot be resolved. Any member of the IACUC may, at any time, request to see the revised submission and/or request FCR.
• Tabled, Require FCR: The submission must be revised per the Committee's questions and/or requests for clarifications and resubmitted for FCR at a convened meeting.
• Approval Withheld: The submission is not eligible to be reviewed again by the Committee. The Institutional Official will be copied on the letter to the PI for any protocol where approval has been withheld.

IACUC Final Approval Requirements

Once a submission is "recommended for approval" it will receive Final Approval as soon as the Office of Environmental Health and Safety (OEHS) grants approval (i.e. Institutional Biosafety Committee, Radiation Safety, Chemical Hazards, Chemical Safety Committee, ANICON, training courses) and all IACUC-required training (i.e. CITI online modules, Division of Laboratory Resources hands-on training) has been completed. Final approval of renewal protocols may be "delayed" synchronizing with the expiration date of the associated expiring protocol, but only if the expiration date is within three weeks of the date of "recommended approval" of the renewal protocol. Approval of protocols is granted for a period of no more than three years and any changes must be submitted for review via the amendment process. Amendment submissions expire at the end of the original protocol approval period.

Annual Review and Approval of Protocols

After the first and second year, the investigator is only required to submit an annual/continuing review in the following circumstance:

• A protocol funded by the Department of Defense (DoD or the Veterans Administration (VA) and involving USDA-covered species.

All projects continuing beyond the third year must submit a new protocol to the Committee.

Approved: February 2009

Revision Approved: December 2012, November 2014, December 2015, October 2018, July 2019, June 2022, April 2023, September 2024