BACKGROUND

This Standard Operating Procedure (SOP) provides a detailed description of procedures for Designated Member Review (DMR) followed by the IACUC.

IACUC Procedure

The IACUC may use Designated Member Review to process the following:

1) A new protocol submission

2) An amendment request

3) A revised protocol that was reviewed by the Full Committee and categorized as Modifications Required followed by DMR. The committee members present at the meeting must decide by unanimous vote to use DMR to review the protocol after it has been modified, therefore the IACUC at large does not need to be polled regarding DMR.

4) A protocol that requires continuing/annual review:

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

Prior to using the Designated Member Review process for protocols or amendments, the IACUC at large is polled as to whether or not DMR is appropriate. If any member objects to DMR, the submission will automatically be reviewed by the full committee (FCR).

During the Designated Member Review process, at least one IACUC member is assigned by the Chairperson (or designee) to conduct the review. A veterinarian pre-reviews all protocols and reviews all amendment submissions except for the following circumstances:

• Changes in funding
• Changes in rooms (unless adding a non-DLAR room)
• Adding off-site collaboration
• Revisions to animal numbers
• Changes to or addition of tissue collection
• Changes to or addition of breeding (only pair or trio breeding in mice or pair breeding in rats)
• Changes to or addition of genotyping (unless toe clipping)

A protocol that was originally reviewed full committee (and was voted Modifications Followed by DMR) will be assigned to one (or both) of the IACUC member(s) who originally reviewed the protocol at the convened meeting.

During the DMR review process, IACUC members can call for Full Committee Review (FCR) at any time. The designated reviewer(s) can take any of the following actions:

• Recommend 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.
• Require 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.
• Require Full Committee Review

Final Approval

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.  Approval of new protocols is granted for a period of no more than three years with instructions that the protocol must be reviewed on an annual basis to remain active, 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 a USDA-covered species.

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

Approved: March 2009

Revisions Approved: 12/2012, 12/2015, 4/2016, 12/2017, 7/2019, 6/2021, 5/2022, 7/2022