Policy Number: 2002-020-c
Policy Title: Designated Review of Protocols

Purpose: Both the Public Health Service Policy on Humane Care and Use of Laboratory Animals and the Animal Welfare Act regulations regarding review and approval of animal activities, described in animal protocols, allow for the use of Designated Review of those activities. This policy details the circumstances under which the Designated Review process is practiced by the UW-Madison Animal Care and Use Committees (ACUCs), and how the Designated Review process is implemented.

POLICY: The Designated Review method of protocol review and approval is practiced in three circumstances, described below. On an annual basis each ACUC shall review and ratify this policy at a convened meeting.

Protocol amendments to identify procedures in a grant proposal to be performed in years beyond those of a current ACUC-approved protocol must be handled via method 1 of this policy. Such amendments must be clear that such procedures will not be performed without ACUC approval.

  1. Designated Review can be used as an alternative to review of a protocol at a legally convened meeting. The process described below will be used to facilitate Designated Review.
    1. All voting committee members will be provided with a full copy (electronic or hard-copy) of each protocol for which Designated Review is requested. Specific eligibility is left to the discretion of the individual school/college-level ACUC.
    2. Any voting committee member may request that a protocol undergo review at a legally convened meeting ("full-committee review"). If such a request is made, then the protocol will be reviewed by way of the normal full-committee review/approval process. Such full-committee review/approval will be conducted at a convened meeting with a constituted quorum of members present and eligible to vote.
    3. While a request for full-committee review of a protocol can be made anytime, for the purpose of keeping the review/approval timely, if the response deadline for voting committee members as designated by the chair has passed without a request for full-committee review, the chair will initiate the Designated Review process.
    4. To proceed with the Designated Review process, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, shall review the protocol, and have the authority to approve, require modifications in (to secure approval), or request full-committee review of the protocol. If the chair assigns multiple designated reviewers, there must be unanimous approval by all designated reviewers. If there is not unanimous agreement, the protocol will automatically go to the full committee for review. Disapproval of a protocol requires full-committee action.
    5. Animal use protocols that are submitted for the purpose of serving as umbrella grants (e.g., base training grants) will be reviewed via Designated Review by the appropriate ACUC Chair and Senior Program Veterinarian. Either may call for full-committee review of such protocols, in which case the protocol will be scheduled for the next legally convened ACUC meeting.
    6. Subsequent submissions (rewrites) of protocols that are deferred at a convened ACUC meeting cannot be approved for Designated Review at that meeting unless all voting members are present and unanimously vote to approve the rewrite for Designated Review and select those Reviewers at the time of the vote.
    At least quarterly, the full ACUC shall be provided for review a copy of the log of amendments reviewed and approved by the Designated Review described above. Any ACUC member may request a full-committee review of any previously approved amendment noted on the log.
  2. Designated Review by the ACUC Chair (or vice-chair if a conflict of interest exists) and Senior Program Veterinarian (or veterinary designee) can be used when an amendment to an ACUC-approved protocol is limited to one or more of the criteria below.
    • Addition of locations where procedures are conducted on animals, or where other animal activities of a duration less than 12 hours occur
    • Addition of an ACUC-approved housing location within the reviewing ACUC’s oversight
    • Qualifications and training of instructors invited by the university to teach specific procedures, generally for continuing education courses, in lieu of completing on-line animal user orientation for UW-Madison
    • The addition of adopting out animals at the end of a study following established school/college procedures and RARC veterinary approval
    • The addition of language to allow the transfer of animals between ACUC-approved protocols with RARC veterinary approval
    • Changing from one approved commercial source of animals to another
    • Changing brand names of materials or substances (e.g., “Kleenex” instead of “Puffs”)
    • Changing from a specific brand name to a generic term (e.g., from “Kleenex” to “tissue”)
    • Decreasing the frequency or volume of previously approved blood draws
    • Removal of procedures and/or procedure locations
    At their discretion, either the ACUC Chair or Senior Program Veterinarian may refer any amendment to full-committee review. Any amendment not falling within the guidelines will automatically require Designated Review via method 1 of this policy or at a convened meeting.

    At least quarterly the full ACUC shall be provided for review a copy of the log of amendments reviewed and approved by the ACUC Chair and Senior Program Veterinarian. Any ACUC member may request a full-committee review of any previously approved amendment noted on the log.
  3. Designated Review can be used following an ACUC approval of a motion to require modifications to secure approval. The Designated Reviewer in this circumstances shall be the Senior Program Veterinarian or other voting committee member as determined by the ACUC Chair.

See also ACAPAC Policy 2016-058, “Veterinary Verification and Consultation (VVC)”.

Author: H. McEntee
ePublication Date: 12/14/1999
History: amended 1/2010, 2/2010, 12/2012, 4/2013, 8/2014, 4/2016