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IACUC Review of Protocols

Upon receipt of a new protocol, the IACUC Chair will distribute the protocol by electronic means (e-mail) to the IACUC members with hard copies available also. The e-mail will contain a brief summary of the protocol and any explanatory information from the PI, and a request for a meeting to discuss the proposed protocol. The following topics within the protocol will be examined by the IACUC membership: the rationale and proposed use of animals; the sequence of steps within the protocol; an examination of the suitability of housing, husbandry, surgical procedures; and the adequacy of personnel training and plans to dispose of any hazardous materials generated, along with any specifics concerning the detailed protocol. Review procedures using either Designated Member Review (DMR) or Full Committee Review (FCR) will include:  a determination of whether the protocols are consistent with the OLAW Guidelines, whether they conform with LMU's Assurance, whether they will be conducted in accordance with the USDA Animal Welfare Regulations where applicable, and whether they meet the Public Health Service Policy IV.C.1-3 requirements. Procedures which have not met with IACUC approval cannot be carried out by the PI.

The Chair will solicit all of the IACUC members to determine whether any member wishes to call for a Full Committee Review (FCR). If an FCR is requested, the full committee will meet to discuss the protocol and deliberate on how to proceed. If at all possible, a physically-convened meeting is desirable. If a quorum of IACUC members cannot be physically present, then a telephone conference meeting of a quorum of members will be held. A majority vote by the convened quorum of the IACUC will determine the fate of the protocol. There are three possible outcomes:  approval of the protocolrequirement of modifications to secure approval, or the withholding of approval. A PI may resubmit a modified protocol to meet IACUC requirements or may choose not to modify the protocol in which case IACUC approval would not be granted and animal work may not be conducted.

The method of review of the subsequently revised protocol, as determined during the full committee review, to secure full approval is determined at the convened IACUC meeting. If all members are present, then the committee may vote to have the subsequently revised protocol reviewed by Designated Member Review (see below) or returned for FCR at a convened meeting. A written policy is in place that provides for the situation where only a quorum is present at the initial review meeting. In this case, as long as a quorum is present, the convened members have the authority to send a revised protocol, based upon the recommendations at the convened meeting, for additional review using the DMR.

If no member requests Full Committee Review, then the Designated Member Review (DMR) process will be employed. In this case, the IACUC Chair will designate the members who shall conduct the DMR, typically the Chair and the Veterinarian. The other committee members may submit comments and suggestions to the designated reviewers which the reviewers may choose to consider. The designated reviewers review identical versions of the protocol, and if one reviewer requests modifications then the second reviewer must agree to them as well. Additionally, the reviewers must be unanimous in all of their decisions. The DMR will usually result in either approval of the protocol, or a requirement for modifications to secure approval. If the reviewers cannot agree on the outcome or feel that the full committee should review the modified protocol, then it must go back for FCR.