BACKGROUND

This Standard Operating Procedure (SOP) provides a detailed description of procedures followed by the IACUC for conducting business during a convened meeting.

IACUC Procedure

1. The Chairperson will announce each item of business, following the agenda, and ask if anyone has a conflict of interest with any of the items of business. The member(s) with a conflict of interest will recuse himself/herself before the item of business is discussed.

2. Each item of business comes up for consideration.

a. Any member(s) with a conflict of interest will recuse himself/herself.

b. The Research Compliance Administrator (RCA) will count the voting members left to make sure that a quorum is still present.

c. If a quorum is not present, business on that item cannot be conducted, the Chairperson will notify the committee that the item has been tabled until the next meeting, and the Chairperson will introduce the next item of business. Otherwise, consideration of the item may continue.

d. The Chairperson shall ask for the primary reviewer's comments, followed by the secondary reviewer's comments (if a secondary reviewer has been assigned).

3. Following the presentation of the item of business, the Chairperson will solicit comments about the item from the entire committee, and will ensure that all opinions are heard as part of the deliberation. Once a consensus or a clear division in opinions is apparent, the Chairperson will solicit a motion.

a. Acceptable motions for protocols (or amendments) are: Recommend Approval; Require Modifications to Secure Approval (DMR); Table, (i.e., Request Major Revisions, Requires Full Committee Review); or Withhold Approval. See the Full Committee Review SOP for details.

b. Acceptable motions for issues of potential non-compliance presented by the Sr. Research Compliance Specialist are as follows (see the Investigation and Remediation of Non-Compliance and Animal Welfare Policy for more details):

i. The incident presented is not non-compliance.

ii. The incident presented is non-compliance; the motion can include a plan of action or affirm that the action already taken was appropriate; the severity of the incident will be one of the following:

1. Serious Non-Compliance

2. Continuing Non-Compliance

3. Minor Non-Compliance

All issues of serious or continuing non-compliance will be reported to the Institutional Official

c. Acceptable motions for other business items (e.g. IACUC minutes, policies, forms, semi-annual program review) are: approve, approve with modifications discussed, disapprove, or table.

i. Members can submit minority views regarding semi-annual program review and/or facilities' inspections for inclusion in the Program Review report to the Institutional Official (IO).

4. Once the reviewer makes a motion, it must be seconded by another voting member to remain active.

a. If the motion is seconded, then the Chairperson will ask for further discussion. The reviewer who made the motion may alter the motion if further discussion prompts a change. If the motion is altered, it must receive another second to be valid.

b. If the motion does not receive a second, then the Chairperson will ask for a motion from any voting member of the IACUC (go to item 4.a.). This process will continue until a motion has been successfully seconded.

5. The Chairperson will then ask the members to vote "in favor," "opposed," or "abstain."

a. For the motion to pass, a majority of the quorum present must vote "in favor". If the motion does not pass, the Chairperson will declare the motion dead, and solicit another motion (go to item 4).

i. The one exception to "majority rules" during a vote by the IACUC is the a motion to Require Modifications to Secure Approval (DMR) of a protocol or amendment must be decided by a unanimous vote so the protocol can be reviewed by Designated Member Review after modifications have been made. If the vote is not unanimous, the protocol or amendment requires Full Committee Review and, therefore, must be Tabled. This procedure fulfills the requirement outlined in NIH Notice Number NOT-OD-09-035.

b. The Chairperson will ask the Research Compliance Administrator (RCA) to record the Committee decision.

c. The Chairperson will then ask if any member wishes to submit a dissenting (minority) opinion for inclusion in the minutes. If no requests are made, the Chairperson will ask that any member(s) who recused himself/herself to return to the meeting, and then introduce the next item of business (go to item 2).

Approved: February 2008

Revision Approved: December 2012, October 2018, August 2022