The Designated Member Review method of protocol review and approval is practiced in three circumstances, described below. On an annual basis each IACUC 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 IACUC-approved protocol must be handled via method I of this policy. Such amendments must be clear that such procedures will not be performed without IACUC approval.
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Designated Member Review (DMR) 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 Member Review.
- All voting committee members will be provided with a full copy (electronic or hard-copy) of each protocol for which Designated Member Review is requested. Specific eligibility is left to the discretion of the individual school/college-level IACUC.
- Any voting committee member may request that a protocol undergo review at a legally convened meeting ("full-committee review" FCR). 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.
- 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 Member Review process.
- To proceed with the Designated Member 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.
- Animal use protocols that are submitted for the purpose of serving as umbrella grants (e.g., base training grants) will be reviewed via Designated Member Review by the appropriate IACUC 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 IACUC meeting.
- Subsequent submissions (rewrites) of protocols that are deferred at a convened IACUC meeting cannot be approved for Designated Member Review at that meeting unless all voting members are present and unanimously vote to approve the rewrite for Designated Member Review and select those Reviewers at the time of the vote.
- At least quarterly, the full IACUC shall be provided for review a copy of the log of amendments reviewed and approved by the Designated Member Review described above. Any IACUC member may request that a previously approved protocol be brought to a convened meeting for discussion. Following the full committee discussion, the committee votes to determine if the protocol should remain active, an amendment solicited, or protocol suspended. Review of active protocols at a meeting is considered part of the UW-Madison post-approval monitoring program.
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Designated Member Review by the IACUC 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 IACUC-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 IACUC-approved housing location within the reviewing IACUC’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 IACUC-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 IACUC Chair or Senior Program Veterinarian may refer any amendment to full-committee review. Any amendment not falling within the guidelines will automatically require Designated Member Review via method I of this policy or at a convened meeting.
- At least quarterly the full IACUC shall be provided for review a copy of the log of amendments reviewed and approved by the IACUC Chair and Senior Program Veterinarian. Any IACUC member may request a full-committee review of any previously approved amendment noted on the log.
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Designated Member Review can be used following an IACUC approval of a motion at a convened meeting to require modifications to secure approval.
In the third circumstance covered by this policy, modifications requested by the IACUC during FCR may be reviewed by DMR. All members have agreed 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 modification is needed to secure approval. At least one voting member of the IACUC, typically a laboratory animal veterinarian reviews the rewrite. Additional reviewers may be named by the chair, however, if there is more than one reviewer, all reviewers must be unanimous in approving the requested modifications. All members may view the rewrite and any IACUC member may request that the rewrite come back to the committee for FCR. The process for DMR following FCR is reviewed and reapproved by each of the IACUCs annually.
See also UW-4132 Veterinary Verification and Consultation (VVC)
