Designated Member Review (DMR) is one method of approving animal use proposals that is compliant with US Department of Agriculture and PHS guidelines1,2. The DMR process gives the designated reviewer full authority to approve the protocol but also requires that all committee members have the opportunity to look at the protocol and call for FCR prior to assignment for DMR. It appears that in this case, Sean Smith forfeited his right to call for FCR as an IACUC member during this specific pre-DMR review period. He wrongly assumed that the designated reviewer, who is also the AV, would require analgesia in this study. This case illustrates the responsibility of each committee member to play his or her role independently, irrespective of perceptions of how other members might make decisions.
The Office of Laboratory Animal Welfare guidance that Liz used to support her contention that any IACUC member could request FCR of a protocol was taken out of context. The guidance that Liz quoted is specific to the use of DMR subsequent to FCR3 and does not apply in this scenario. The specific wording in the guidance refers to the situation that could arise if a committee had voted to allow use of the DMR process to review modifications required for approval that were stipulated by members during a convened meeting of the full committee. In that case, PHS allows for required modifications to be reviewed by the DMR process under two conditions: (i) 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 this method, and (ii) any member of the IACUC may, at any time, request to see the revised protocol or request FCR of the protocol. As stated previously, one required element of the DMR process is that all IACUC members must be given the opportunity to call for FCR. In our opinion, the provision presented in this guidance was stipulated specifically to allow members not present at the meeting the opportunity to call for FCR of any protocols sent for subsequent DMR during the FCR process. There is no provision in this guidance or in others that allows members more than one opportunity to call for FCR if they have second thoughts prior to approval. After approval, however, any member may request additional review of any protocol if he or she has concerns about animal welfare.
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