University of Wisconsin-Madison

Policy Number: 2002-020 [PDF]

Adoption Date: 12/14/1999

Effective Date: 12/14/1999

Expiration Date: ongoing

Review Date: Annually

Designated Review of Protocols

Purpose: The language of the Public Health Service Policy on Human Care and Use of Laboratory Animals and the Animal Welfare Act regulations on protocol review and approval is the following: " Prior to the review, each IACUC member shall be provided with a list of proposed research projects to be reviewed. Written descriptions of research projects that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full committee review of those research projects. If full committee review is not requested, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval) or request full committee review of those research projects. If full committee review is requested, approval of those research projects may be granted only after review at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present. No member may participate in the IACUC review or approval of a research project in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum." It is from this language that the alternative to the full-committee

review/approval method has its basis. This alternative method is commonly referred to as the "designated reviewer(s)" method. This policy details the U.W.-Madison's guidelines for conducting a "designated reviewer(s) approval of a protocol.

Policy:

1. All voting committee members will be provided with a list of all protocols that are eligible for the "designated reviewer(s) method of review/approval. Specific eligibility is left to the discretion of the individual school/college level ACUC. Committee members may also request a copy of the written protocol.
2. Any committee member may request that a protocol undergo a 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 committee members as designated by the chair has passed without a request for full-committee review, the chair will initiate the designated reviewer process.
4. To proceed with the designated reviewer 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 the base for 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 fully convened ACUC meeting.

Prepared by: R. Lane, H. McEntee

Reference Minutes: 12/14/1999, 05/04/07