Policy governing Full Committee Review (FCR) and Designated Member Review (DMR)

Reviewed and Adopted by IACUC on February 8, 2024

  1. Under normal conditions, all submitted AUPs would be reviewed by the full IACUC committee (FCR) method at its next regularly scheduled meeting, which are typically held remotely in compliance to NIH Guidance (NOT-OD-06-052).
  2. Deadlines for submission prior to a regularly scheduled meeting will be announced at regular intervals.
  3. If the PI requests earlier consideration than is possible at the next scheduled meeting, the chair will submit the AUP to the full committee for consideration of a designated review, as described below.
  4. Any member of the IACUC may request in writing a full committee review of the AUP within 5 working days from the distribution of the AUP.
  5. The new AUPs will be sent to all committee members for their initial review. We will conduct FCR if there is a request from IACUC. If there is no request, the Chair will appoint a member to perform DMR followed by a FCR at a convened meeting.
  6. Full committee review may result in approval, a requirement for modifications (to secure approval), or withholding of approval. Full committee review must occur during a convened meeting of a quorum of the IACUC members. The motion is passed with a formal majority vote following Robert’s Rule.
  7. It will be insufficient to poll each member individually in lieu of a convened quorum when using the FCR method. When substantive information is lacking from a protocol and the committee may have questions requiring response from the PI, the IACUC will take the following actions:
    • If all members of the IACUC are present at a meeting, the committee will vote to require modifications to secure approval and have the revised research protocol reviewed and approved by designated member review (DMR), or returned to 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 stipulations. 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 modifications is needed to secure approval. However, any member of IACUC may, at any time, request to see the revised protocol and/or request FCR of the approval.
    • If the IACUC uses the DMR, following FCR, the approval date shall be the date that the designated member(s) approve the study.
    • If IACUC elects to use DMR subsequent to FCR, the IACUC chair will appoint one or more appropriately qualified members to serve as the designated reviewer(s).
    • If a full committee review of the AUP is not requested by any member of the IACUC, the AUP may be reviewed by the designated reviewer method (DMR). The DMR may be utilized only after all members have been provided the opportunity to call for full-committee review. If any member requests full committee review then that method must be used. If not, the IACUC chair may appoint one or more appropriately qualified IACUC members to serve as the designated reviewer(s). Designated reviewers shall be appointed during a quorum meeting of the IACUC committee. Designated review may result in approval, a requirement for modifications (to secure approval) or referral to the full committee for review. Designated review may not result in withholding of approval. Approval or request for full committee review will be determined by unanimous decision of the designated review committee. If a full committee review is requested, a special meeting of the IACUC may be convened at the discretion of the IACUC Chair, otherwise the review will occur during the next regular meeting of the IACUC. The action taken by the designated review committee will be presented at the next convened meeting of the IACUC.
    • Both the FCR and DMR reviews of the animal protocols will strictly be governed by the following regulations.
      • No member may participate in the review of an AUP or project, except to provide information as requested by the IACUC, if that member has a vested or conflicting interest in the project. Nor may a member who has a vested or conflicting interest contribute to the constitution of the quorum (a majority of the members of the IACUC) for the approval or disapproval of the AUP or project being reviewed.
      • Each AUP or project that requires committee attention will be reviewed according to NIH regulations to ensure that proper care and humane treatment of animals used in research, testing and education is not violated. The IACUC will determine that AUP or the projects subject to review have satisfied regulations regarding animal husbandry, pain, and distress and literature review of alternative animal models for research. Such literature reviews shall be conducted with an emphasis on reduction, refinement or replacement of animal models.
  8. The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC committee.
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